Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IA2 Cervical Cancer AJCC v6 and v7, Stage IB1 Cervical Cancer AJCC v6 and v7
Conditions
Brief summary
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features. SECONDARY OBJECTIVES: I. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features. II. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy. III. To estimate the sensitivity of sentinel lymph node biopsy in the determination of pelvic lymph node metastases in this group of patients. IV. To compare the treatment-associated morbidity in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy. V. To assess quality of life factors, sexual functioning, symptoms and satisfaction with healthcare decisions in this group of patients. OUTLINE: Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy. After completion of study treatment, patients are followed up every 3 months for 2 years and then yearly for 3 years.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
PROCEDURESalpingo-Oophorectomy
Undergo hysterectomy with or without salpingo-oophorectomy
PROCEDURESentinel Lymph Node Biopsy
Undergo lymphatic mapping with sentinel lymph node biopsy
PROCEDURELymph Node Mapping
Undergo lymphatic mapping with sentinel lymph node biopsy
PROCEDURETherapeutic Conventional Surgery
Undergo hysterectomy with or without salpingo-oophorectomy
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix * International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease * Tumor diameter =\< 2 cm on physical exam and on imaging studies * No lymphovascular space invasion (LVSI) present on biopsy or previous cone * Less than 10 mm of cervical stromal invasion * Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within 1.0 mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ \[AIS\] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted) * Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria * Patients must sign an approved informed consent document * If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study * Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment
Exclusion criteria
* Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies * Grade 3 adenocarcinoma * FIGO stage IA1, IB2, II, III or IV disease * Tumors \> 2 cm in diameter on physical exam or imaging studies * Presence of LVSI * Greater than or equal to 10 mm of cervical stromal invasion * Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted) * Neoadjuvant radiation therapy or chemotherapy for cervical cancer * Patients unwilling or unable to provide informed consent for the study * Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment * Patients who have had a simple hysterectomy (cut through hysterectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | Approximately 9 years | The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | 2 years | Recurrence rate was estimated and was measured from the date of surgery to the earliest date of the last clinic visit, date of first recurrence, or date of death. |
| Number of Participants With All-Cause Mortality | Approximately 9 years | Total patient morbidity within 30 days following conservative surgery |
Countries
Argentina, Australia, Brazil, Colombia, Mexico, Peru, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fertility Sparing Conization followed by lymph node assessment only | 44 |
| Conization + Hysterectomy + Lymph Node Assessment Conization followed by hysterectomy and lymph node assessment | 40 |
| Simple Hysterectomy Inadvertent simple hysterectomy followed by lymph node dissection | 16 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Fertility Sparing | Total | Simple Hysterectomy | Conization + Hysterectomy + Lymph Node Assessment |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 99 Participants | 16 Participants | 39 Participants |
| Age, Continuous | 31 years | 39 years | 47 years | 43 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 52 Participants | 5 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 32 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 16 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 28 Participants | 2 Participants | 13 Participants |
| Race (NIH/OMB) White | 28 Participants | 65 Participants | 12 Participants | 25 Participants |
| Region of Enrollment Argentina | 6 participants | 7 participants | 0 participants | 1 participants |
| Region of Enrollment Australia | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Brazil | 10 participants | 19 participants | 3 participants | 6 participants |
| Region of Enrollment Colombia | 4 participants | 14 participants | 2 participants | 8 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Mexico | 1 participants | 4 participants | 0 participants | 3 participants |
| Region of Enrollment Peru | 4 participants | 13 participants | 1 participants | 8 participants |
| Region of Enrollment Thailand | 1 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 17 participants | 40 participants | 10 participants | 13 participants |
| Sex: Female, Male Female | 44 Participants | 100 Participants | 16 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 44 | 0 / 40 | 0 / 16 |
| other Total, other adverse events | 5 / 44 | 5 / 40 | 4 / 16 |
| serious Total, serious adverse events | 5 / 44 | 3 / 40 | 1 / 16 |
Outcome results
Primary
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment.
Time frame: Approximately 9 years
Population: Fertility Sparing - hysterectomy not performed. Simple Hysterectomy - hysterectomy performed prior to study enrollment.~Conization + hysterectomy + lymph node assessment group was only group assessed as Fertility Sparing did not have hysterectomy and the Simple Hysterectomy group had hysterectomy performed prior to study enrollment making them inevaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conization + Hysterectomy + Lymph Node Assessment | Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | 2.5 percentage of participants |
Secondary
Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
Recurrence rate was estimated and was measured from the date of surgery to the earliest date of the last clinic visit, date of first recurrence, or date of death.
Time frame: 2 years
Population: Only 42 participants out of 44 in the fertility sparing group were evaluated; 1 participant expired following the surgical procedure and 1 participant was lost to follow up prior to the 2 year interval. In the conization + hysterectomy group, 4 participants of the 40 in this group were lost to follow up prior to the 2 year interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fertility Sparing | Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | 2.4 percentage of participants |
| Conization + Hysterectomy + Lymph Node Assessment | Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | 0 percentage of participants |
| Simple Hysterectomy | Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features | 12.5 percentage of participants |
Secondary
Number of Participants With All-Cause Mortality
Total patient morbidity within 30 days following conservative surgery
Time frame: Approximately 9 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fertility Sparing | Number of Participants With All-Cause Mortality | 1 Participants |
| Conization + Hysterectomy + Lymph Node Assessment | Number of Participants With All-Cause Mortality | 0 Participants |
| Simple Hysterectomy | Number of Participants With All-Cause Mortality | 0 Participants |