Cancer of Cervix
Conditions
Brief summary
The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.
Interventions
DRUGGemcitabine
DRUGCisplatin
RADIATIONBrachytherapy
Brachytherapy, 30-35 Gy over 1 week
RADIATIONPelvic radiation
Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with cancer of cervix * tumor that can be measured * no previous treatment with chemotherapy or radiation for this cancer * Karnofsky Performance Status Score \>=70 * able to give written consent * willing and able to participate in the study, both during the active treatment and the follow-up period.
Exclusion criteria
* impairment such as hearing loss from prior cisplatin therapy * damage to nerves such as being unable to distinguish hot and cold to touch * used other experimental medication in past 30 days * lab test results are not within the limits required for this study * pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented. |
| Local Failure Rate | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b). |
| Tumor Response | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response. |
| Number of Participants Who Died From Any Cause at Various Time Points | baseline to date of death from any cause (includes 60 month follow-up period) | Original outcome was Overall Survival, which was defined as time from baseline to death from any cause. |
| Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively | Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause. |
Countries
Argentina, Bosnia and Herzegovina, India, Mexico, Pakistan, Peru, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine/Cisplatin/Radiation Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles | 259 |
| Cisplatin/Radiation Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week | 256 |
| Total | 515 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 1 |
| Overall Study | Clinical Relapse | 2 | 1 |
| Overall Study | Death from Other Cause | 1 | 0 |
| Overall Study | Death from Study Drug Toxicity | 2 | 0 |
| Overall Study | Lack of Efficacy, Progressive Disease | 1 | 2 |
| Overall Study | Lack of Efficacy, Stable Disease | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Patient Moved | 0 | 1 |
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Protocol Entry Criteria Not Met | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Reason Not Specified | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 3 |
Baseline characteristics
| Characteristic | Cisplatin/Radiation | Gemcitabine/Cisplatin/Radiation | Total |
|---|---|---|---|
| Age Continuous | 46.5 years STANDARD_DEVIATION 9.2 | 45.8 years STANDARD_DEVIATION 9.8 | 46.1 years STANDARD_DEVIATION 9.5 |
| Grade of Histological Diagnosis Moderately Differentiated | 119 participants | 114 participants | 233.0 participants |
| Grade of Histological Diagnosis Poorly Differentiated | 44 participants | 48 participants | 92.0 participants |
| Grade of Histological Diagnosis Undifferentiated | 0 participants | 2 participants | 2.0 participants |
| Grade of Histological Diagnosis Unknown | 69 participants | 69 participants | 138.0 participants |
| Grade of Histological Diagnosis Well Differentiated | 24 participants | 26 participants | 50.0 participants |
| Height | 154.6 centimeters STANDARD_DEVIATION 6.7 | 155.2 centimeters STANDARD_DEVIATION 6.6 | 154.9 centimeters STANDARD_DEVIATION 6.6 |
| Karnofsky Performance Status Scale 100 - Normal no complaints; no evidence of disease | 101 participants | 103 participants | 204.0 participants |
| Karnofsky Performance Status Scale 70 - Unable to carry on normal activity | 1 participants | 0 participants | 1.0 participants |
| Karnofsky Performance Status Scale 80 - Activity with effort; some signs of disease | 9 participants | 8 participants | 17.0 participants |
| Karnofsky Performance Status Scale 90 - Normal activity; minor signs of disease | 145 participants | 147 participants | 292.0 participants |
| Karnofsky Performance Status Scale Unknown (Missing) | 0 participants | 1 participants | 1.0 participants |
| Pathological Diagnosis Adenocarcinoma of Cervix | 15 participants | 17 participants | 32.0 participants |
| Pathological Diagnosis Adeno/Squamous Cell Carcinoma | 199 participants | 198 participants | 397.0 participants |
| Pathological Diagnosis Other - Poorly Differentiated Carcinoma | 0 participants | 1 participants | 1.0 participants |
| Pathological Diagnosis Other - Squamous | 42 participants | 43 participants | 85.0 participants |
| Race/Ethnicity Caucasian | 29 participants | 33 participants | 62.0 participants |
| Race/Ethnicity East/Southeast Asian | 33 participants | 34 participants | 67.0 participants |
| Race/Ethnicity Hispanic | 109 participants | 105 participants | 214.0 participants |
| Race/Ethnicity Western Asian | 85 participants | 87 participants | 172.0 participants |
| Region of Enrollment Argentina | 18 participants | 17 participants | 35.0 participants |
| Region of Enrollment Bosnia and Herzegovina | 28 participants | 33 participants | 61.0 participants |
| Region of Enrollment India | 56 participants | 60 participants | 116.0 participants |
| Region of Enrollment Mexico | 31 participants | 28 participants | 59.0 participants |
| Region of Enrollment Pakistan | 29 participants | 27 participants | 56.0 participants |
| Region of Enrollment Panama | 30 participants | 31 participants | 61.0 participants |
| Region of Enrollment Peru | 31 participants | 29 participants | 60.0 participants |
| Region of Enrollment Thailand | 33 participants | 34 participants | 67.0 participants |
| Sex: Female, Male Female | 256 Participants | 259 Participants | 515.0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0.0 Participants |
| Stage of Disease Stage IIB | 156 participants | 160 participants | 316.0 participants |
| Stage of Disease Stage IIIA | 1 participants | 1 participants | 2.0 participants |
| Stage of Disease Stage IIIB | 94 participants | 94 participants | 188.0 participants |
| Stage of Disease Stage IVA | 5 participants | 4 participants | 9.0 participants |
| Weight | 62.4 kilograms STANDARD_DEVIATION 13 | 61.2 kilograms STANDARD_DEVIATION 11.3 | 61.8 kilograms STANDARD_DEVIATION 12.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 259 / — | 251 / — |
| serious Total, serious adverse events | 44 / — | 17 / — |
Outcome results
Primary
Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted Measure Type, so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.
Time frame: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Population: Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | 3 Years: Number of Patients with Event | 55 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | 3 Years: Number of Patients at Risk | 149 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | 3 Years: Number of Patients with Event | 83 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | 3 Years: Number of Patients at Risk | 141 participants |
p-value: 0.02995% CI: [0.01, 0.179]Z Statistic
Secondary
Local Failure Rate
Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b).
Time frame: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Population: Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Local Failure Rate | 0.113 proportion of participants with PD |
| Cisplatin/Radiation | Local Failure Rate | 0.166 proportion of participants with PD |
Comparison: Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure.p-value: 0.096Fisher Exact
Secondary
Number of Participants Who Died From Any Cause at Various Time Points
Original outcome was Overall Survival, which was defined as time from baseline to death from any cause.
Time frame: baseline to date of death from any cause (includes 60 month follow-up period)
Population: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 3 Months: Number of Patients with Event | 3 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 3 Months: Number of Patients at Risk | 253 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 6 Months: Number of Patients with Event | 9 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 6 Months: Number of Patients at Risk | 241 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 12 Months: Number of Patients with Event | 22 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 12 Months: Number of Patients at Risk | 226 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 18 Months: Number of Patients with Event | 33 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 18 Months: Number of Patients at Risk | 207 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 24 Months: Number of Patients with Event | 39 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 24 Months: Number of Patients at Risk | 200 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 36 Months: Number of Patients with Event | 53 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 36 Months: Number of Patients at Risk | 175 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 36 Months: Number of Patients with Event | 75 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 3 Months: Number of Patients with Event | 0 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 18 Months: Number of Patients with Event | 46 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 3 Months: Number of Patients at Risk | 254 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 24 Months: Number of Patients at Risk | 182 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 6 Months: Number of Patients with Event | 4 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 18 Months: Number of Patients at Risk | 195 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 6 Months: Number of Patients at Risk | 248 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 36 Months: Number of Patients at Risk | 158 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 12 Months: Number of Patients with Event | 25 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 24 Months: Number of Patients with Event | 58 participants |
| Cisplatin/Radiation | Number of Participants Who Died From Any Cause at Various Time Points | 12 Months: Number of Patients at Risk | 222 participants |
p-value: 0.0224Log Rank
Secondary
Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points
Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause.
Time frame: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Population: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 3 Months: Number of Patients with Event | 8 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 3 Months: Number of Patients at Risk | 221 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 6 Months: Number of Patients with Event | 14 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 6 Months: Number of Patients at Risk | 204 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 12 Months: Number of Patients with Event | 29 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 12 Months: Number of Patients at Risk | 186 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 18 Months: Number of Patients with Event | 34 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 18 Months: Number of Patients at Risk | 176 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 24 Months: Number of Patients with Event | 42 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 24 Months: Number of Patients at Risk | 167 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 36 Months: Number of Patients with Event | 55 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 36 Months: Number of Patients at Risk | 149 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 36 Months: Number of Patients with Event | 83 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 3 Months: Number of Patients with Event | 8 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 18 Months: Number of Patients with Event | 63 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 3 Months: Number of Patients at Risk | 238 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 24 Months: Number of Patients at Risk | 158 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 6 Months: Number of Patients with Event | 25 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 18 Months: Number of Patients at Risk | 170 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 6 Months: Number of Patients at Risk | 218 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 36 Months: Number of Patients at Risk | 141 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 12 Months: Number of Patients with Event | 45 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 24 Months: Number of Patients with Event | 72 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | 12 Months: Number of Patients at Risk | 195 participants |
p-value: 0.0227Log Rank
Secondary
Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points
Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented.
Time frame: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Population: Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 3 Months: Number of Patients with Event | 5 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 3 Months: Number of Patients at Risk | 221 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 6 Months: Number of Patients with Event | 10 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 6 Months: Number of Patients at Risk | 204 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 12 Months: Number of Patients with Event | 21 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 12 Months: Number of Patients at Risk | 186 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 18 Months: Number of Patients with Event | 24 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 18 Months: Number of Patients at Risk | 176 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 24 Months: Number of Patients with Event | 31 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 24 Months: Number of Patients at Risk | 167 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 36 Months: Number of Patients with Event | 40 participants |
| Gemcitabine/Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 36 Months: Number of Patients at Risk | 149 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 36 Months: Number of Patients with Event | 78 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 3 Months: Number of Patients with Event | 8 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 18 Months: Number of Patients with Event | 62 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 3 Months: Number of Patients at Risk | 238 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 24 Months: Number of Patients at Risk | 158 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 6 Months: Number of Patients with Event | 25 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 18 Months: Number of Patients at Risk | 170 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 6 Months: Number of Patients at Risk | 218 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 36 Months: Number of Patients at Risk | 141 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 12 Months: Number of Patients with Event | 44 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 24 Months: Number of Patients with Event | 69 participants |
| Cisplatin/Radiation | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | 12 Months: Number of Patients at Risk | 195 participants |
p-value: 0.0008Log Rank
Secondary
Tumor Response
Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response.
Time frame: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Population: Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Radiation | Tumor Response | Complete Response | 223 participants |
| Gemcitabine/Cisplatin/Radiation | Tumor Response | Partial Response | 22 participants |
| Cisplatin/Radiation | Tumor Response | Complete Response | 217 participants |
| Cisplatin/Radiation | Tumor Response | Partial Response | 20 participants |
p-value: 0.25Fisher Exact