Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IB Cervical Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7
Conditions
Brief summary
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival. SECONDARY OBJECTIVES: I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes. V. To determine patient quality of life, including psycho-sexual health. TERTIARY OBJECTIVES: I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4-6 months post completion of chemoradiation and outcomes for all patients in the trial. II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy. ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo baseline tumor biopsy and blood collection for future correlative studies. Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Interventions
RADIATIONBrachytherapy
Undergo brachytherapy
DRUGCarboplatin
Given IV
DRUGCisplatin
Given IV
RADIATIONExternal Beam Radiation Therapy
Undergo external beam radiation therapy
DRUGPaclitaxel
Given IV
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
GOG Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to: * Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive, IB2, IIA, IIB, IIIB, or IVA disease * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix * White blood cells (WBC) \>= 3.0 x 10\^9/L * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelet count \>= 100 x 10\^9/L * Bilirubin =\< 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x ULN (if both tests are done, both results need to be =\< 2.5 x ULN) * Creatinine =\< ULN (Common Toxicity Criteria \[CTC\] grade 0) OR calculated creatinine clearance (Cockcroft-Gault formula) \>= 60 mL/min OR \>= 50 mL/min by ethylenediaminetetraacetic acid (EDTA) creatinine clearance * Written informed consent
Exclusion criteria
* Any previous pelvic radiotherapy * Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or \>= 15 mm short-axis diameter on computed tomography \[CT\]) * FIGO 2008 stage IIIA disease * Patients assessed at presentation as requiring interstitial brachytherapy treatment * Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria * Previous chemotherapy for this tumor * Evidence of distant metastases * Prior diagnosis of Crohn's disease or ulcerative colitis * Peripheral neuropathy \>= grade 2 (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]4) * Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years * Patients who are pregnant or lactating * Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy * Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Patients who are known to be human immunodeficiency virus (HIV) positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate at 5 Years | 5 years from study randomization | Estimate for probability of overall survival at 5 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival Rate at 5 Years | 5 years from study randomization | Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study. |
| Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | 1 year after randomization | Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0. |
| Patterns of Disease Recurrence | through study completion an average of 60 months | Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of progression. |
| Radiation Protocol Compliance | Average duration of 7 weeks | Radiation protocol compliance measured by external beam dose delivered |
| Quality of Life for Global Health Status | Baseline and 12 months | Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome. |
Countries
Canada, China, Saudi Arabia, Singapore, United States
Participant flow
Recruitment details
Study was open to accrual on January 9th 2012. Accrual ended on June 28th 2017
Participants by arm
| Arm | Count |
|---|---|
| Standard Chemoradiation patients receive 45 - 50.4 Gy external beam radiation therapy (EBRT) delivered in fractions of 1.8 Gy to the pelvis, followed by brachytherapy. Cisplatin was given during the radiation at a dose of 40mg/m2 weekly for 5 doses to all patients. | 456 |
| Standard Chemoradiation With Adjuvant Chemotherapy patients receive 45 - 50.4 Gy external beam radiation therapy (EBRT) delivered in fractions of 1.8 Gy to the pelvis, followed by brachytherapy. Cisplatin will be given during the radiation at a dose of 40mg/m2 weekly for 5 doses to all patients. Within 4 weeks of completion of all radiation treatment, and following recovery from toxicities, patients in Arm B were treated with an additional 4 cycles of 3 weekly adjuvant chemotherapy using carboplatin AUC 5 and paclitaxel 155 mg/m2. | 463 |
| Total | 919 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 5 | 2 |
Baseline characteristics
| Characteristic | Standard Chemoradiation | Standard Chemoradiation With Adjuvant Chemotherapy | Total |
|---|---|---|---|
| Age, Customized 40 - 49 years | 148 Participants | 130 Participants | 278 Participants |
| Age, Customized < 40 years | 139 Participants | 146 Participants | 285 Participants |
| Age, Customized 50 - 59 years | 103 Participants | 117 Participants | 220 Participants |
| Age, Customized > 60 years | 66 Participants | 70 Participants | 136 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 31 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 68 Participants | 53 Participants | 121 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 29 Participants | 58 Participants |
| Race (NIH/OMB) White | 326 Participants | 337 Participants | 663 Participants |
| Sex: Female, Male Female | 456 Participants | 463 Participants | 919 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 123 / 456 | 109 / 463 |
| other Total, other adverse events | 438 / 453 | 360 / 361 |
| serious Total, serious adverse events | 98 / 453 | 107 / 361 |
Outcome results
Primary
Overall Survival Rate at 5 Years
Estimate for probability of overall survival at 5 years by Kaplan-Meier method, where overall survival is defined as the time from randomization to time of death due to any cause or the date of last contact, whichever occurs first.
Time frame: 5 years from study randomization
Population: Eligible subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Chemoradiation | Overall Survival Rate at 5 Years | 71 Percentage of participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Overall Survival Rate at 5 Years | 72 Percentage of participants |
Secondary
Number of Participants With Adverse Events (Grade 3 or Higher) in First Year
Number of participants with a maximum grade of 3 or higher for pre-specified adverse events that occurred during the first year after randomization. Adverse events are graded and categorized using CTCAE v4.0.
Time frame: 1 year after randomization
Population: Arm A:eligible participants who received at least one dose of cisplatin and/or any dose of radiotherapy. Arm B: eligible participants who received at least one dose of adjuvant chemotherapy (carboplatin, paclitaxel, cisplatin or docetaxel)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Cystitis noninfective | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Abdominal pain | 13 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Alanine aminotransferase increased | 4 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Allergic reaction/hypersensitivity | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Alopecia | 0 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Anemia | 32 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Aspartate aminotransferase increased | 3 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Colitis | 2 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Colonic obstruction | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Creatinine Increased | 3 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Proctitis | 2 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Dehydration | 13 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Dermatitis radiation | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Diarrhea | 21 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Enterocolitis | 2 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Fatigue | 7 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Febrile Neutropenia | 9 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Female genital tract fistula | 4 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hearing impaired | 0 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hemorrhage bladder | 3 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hemorrhage rectum | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Lymphocyte count decreased | 208 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Mucositis oral | 2 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Myalgia | 0 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Nausea | 11 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Neutrophil count decreased | 33 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Pain in extremity | 3 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Pelvic pain | 11 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Perineal pain | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Peripheral motor neuropathy | 0 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Peripheral sensory neuropathy | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Platelet count decreased | 5 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Small intestinal obstruction | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Thrombosis/Thrombus/Embolism | 7 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Tumor pain | 6 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Urinary tract pain | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Uterine obstruction | 1 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal Dryness | 0 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal pain | 3 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal stricture | 4 Participants |
| Standard Chemoradiation | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vomiting | 9 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hemorrhage rectum | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vomiting | 15 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Urinary tract pain | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Abdominal pain | 14 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Lymphocyte count decreased | 211 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Alanine aminotransferase increased | 2 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Platelet count decreased | 16 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Allergic reaction/hypersensitivity | 2 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Mucositis oral | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Alopecia | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Proctitis | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Anemia | 64 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Myalgia | 3 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Aspartate aminotransferase increased | 2 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal stricture | 4 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Colitis | 2 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Nausea | 11 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Colonic obstruction | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Small intestinal obstruction | 4 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Creatinine Increased | 3 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Neutrophil count decreased | 71 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Cystitis noninfective | 3 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Uterine obstruction | 2 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Dehydration | 9 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Pain in extremity | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Dermatitis radiation | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Thrombosis/Thrombus/Embolism | 7 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Diarrhea | 20 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Pelvic pain | 6 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Enterocolitis | 3 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal pain | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Fatigue | 9 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Perineal pain | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Febrile Neutropenia | 9 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Tumor pain | 0 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Female genital tract fistula | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Peripheral motor neuropathy | 4 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hearing impaired | 4 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Vaginal Dryness | 1 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Hemorrhage bladder | 3 Participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Number of Participants With Adverse Events (Grade 3 or Higher) in First Year | Peripheral sensory neuropathy | 16 Participants |
Secondary
Patterns of Disease Recurrence
Number of patients for the site of disease recurrence. Disease was considered as persistent if participant had evidence of disease at study entry and disease did not progress during study. Disease status was considered locoregional alone if a participant had disease progression in the pelvis region including vagina after study entry. Disease status was considered distant if a participant had disease progression outside the pelvis (for example the abdomen and lung) after study entry. Criteria used to determine the no progression group includes participants that expired without documentation of progression.
Time frame: through study completion an average of 60 months
Population: Eligible participants. The No Progression recorded group included participants who died due to any causes without documented progression.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Chemoradiation | Patterns of Disease Recurrence | Distant with or without locoregional | 51 participants |
| Standard Chemoradiation | Patterns of Disease Recurrence | Other/Unknown | 53 participants |
| Standard Chemoradiation | Patterns of Disease Recurrence | No Progression recorded | 304 participants |
| Standard Chemoradiation | Patterns of Disease Recurrence | Persistent | 15 participants |
| Standard Chemoradiation | Patterns of Disease Recurrence | Locoregional alone | 33 participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Patterns of Disease Recurrence | Locoregional alone | 47 participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Patterns of Disease Recurrence | Persistent | 5 participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Patterns of Disease Recurrence | Other/Unknown | 37 participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Patterns of Disease Recurrence | Distant with or without locoregional | 42 participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Patterns of Disease Recurrence | No Progression recorded | 332 participants |
Secondary
Progression-free Survival Rate at 5 Years
Estimate for probability of progression free at 5 years by Kaplan-Meier method, where progression-free survival is defined as the time from randomization to the time of disease progression, death from any cause or date of last contact, whichever occurs first. Disease progression is defined by increasing clinical, radiological or pathological evidence of disease from participant entry to when investigator deems a progression. RECIST V1.0 was not used to determine response on this study.
Time frame: 5 years from study randomization
Population: Eligible participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Chemoradiation | Progression-free Survival Rate at 5 Years | 62 Percentage of participants |
| Standard Chemoradiation With Adjuvant Chemotherapy | Progression-free Survival Rate at 5 Years | 63 Percentage of participants |
Secondary
Quality of Life for Global Health Status
Quality of Life measured by change of global health status score from baseline to 12 months follow-up. A cancer-specific questionnaire with 30 items which summarize as five functioning scales, a global health status/quality of life scale, three symptom scales and six single items assessing additional symptoms and perceived financial impact. The minimum global health status score was 0 and the maximum global health status score was 100. A higher global health status score means better outcome.
Time frame: Baseline and 12 months
Population: Eligible participants with Quality of Life at baseline and 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Chemoradiation | Quality of Life for Global Health Status | 1.7 score on a scale | Standard Deviation 22.8 |
| Standard Chemoradiation With Adjuvant Chemotherapy | Quality of Life for Global Health Status | 2.4 score on a scale | Standard Deviation 26.3 |
Secondary
Radiation Protocol Compliance
Radiation protocol compliance measured by external beam dose delivered
Time frame: Average duration of 7 weeks
Population: Eligible and received radiotherapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Chemoradiation | Radiation Protocol Compliance | 45.6 Gray |
| Standard Chemoradiation With Adjuvant Chemotherapy | Radiation Protocol Compliance | 45.7 Gray |