Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer

• ClinicalTrials.gov Identifier: NCT01048853
• Recruitment Status: Active, not recruiting
• First Posted: January 14, 2010
• Last Update Posted: April 13, 2023
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: January 12, 2010
• First Posted Date: January 14, 2010
• Last Update Posted Date: April 13, 2023
• Actual Study Start Date: August 25, 2009
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2022)

• Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen [ Time Frame: Up to 7 days ]
  The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%.
• Recurrence rate [ Time Frame: 2 years ]
  Will estimate with an exact 95% binomial confidence interval.
• Short Form Health Survey SF-12 Questionnaires [ Time Frame: Baseline up to 5 years ]
  Will summarize each of the quality of life instruments (12-Item Short Form Health Survey [SF12], using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval. Short Form Health Survey SF-12: This 12-item questionnaire was developed from the longer SF-36. Scale Score (Excellent 1 Very Good 2 Good 3 Fair 4 , Poor 5)The SF-12 estimates each of eight health domains (physical functioning, role-physical, role-emotional, mental health, bodily pain, vitality, social functioning and general health) using a tool that takes less than 2 minutes to administer. Scores are given in each domain as well as summary scores for overall physical and mental status. Empirical cross-validation studies have shown correlations between the SF-12 and SF-36 surveys ranging from 0.93 to 0.97 [23]
• Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires [ Time Frame: Baseline up to 5 years ]
  Will summarize each of the quality of life instruments Functional Assessment of Cancer Therapy-Cervix [FACT-CX] using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval. Functional Assessment of Cancer Therapy (FACT-CX): The FACT-G is the generic score to measure quality of life for patients with cancer. This instrument contains 27 questions from 4 domains: physical well-being, social/family well-being, emotional well-being, and function well-being. Scale Score ( Not at all 0- A little bit 1, Somewhat 2, Quite a bit 3, Very Much 4)The FACT instruments are well regarded particularly because several disease specific subscales exist, including cervix cancer (FACTCX). The cervix cancer subscale consists of 15 questions pertaining to patients with cervix cancer. The FACT-CX should take about 5 minutes to complete.
• MD Anderson Symptom Inventory MDASI Questionnaires [ Time Frame: Baseline up to 5 years ]
  Will summarize each of the quality of life instruments MD Anderson Symptom Inventory [MDASI], using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval. MD Anderson Symptom Inventory (MDASI): The MD Anderson Symptom Inventory (MDASI) is a 19-item questionnaire. The first 13 items assess patient symptoms during the prior 24 hours and should take less than 3 minutes to complete. Scale Score(Not Present 0-10 Bad as you can imagine) Symptoms assessed include pain, fatigue, nausea/vomiting, anorexia, sleep symptoms, and distress. The last 6 items assess how those symptoms have interfered with the patient's general well-being, including their general activity, mood, ability to walk and perform normal work, as well as their relationships with others and enjoyment of life. The validity and reliability of the MDASI have been well-established [24].
• Female Sexual Functioning Index (FSFI) Questionnaires [ Time Frame: Baseline up to 5 years ]
  Will summarize each of the quality of life instruments Female Sexual Functioning Index [FSFI]) using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval. Female Sexual Functioning Index (FSFI): Sexual functioning will be assessed using the Female Sexual Function Index (FSFI), a 19-item multiple-choice survey that takes approximately 5 minutes to complete [25]. The questionnaire measures sexual desire, arousal (both subjective and physiological), lubrication, orgasm, satisfaction, and pain. Validation studies on sexually dysfunctional and matched control women aged 21 to 70 have demonstrated excellent internal consistency (0.89 to 0.97) and 2 to 4 week test-retest reliability (0.79 to 0.88) for each subscale [25
• Satisfaction with Decision(SWD)Scale Questionnaires [ Time Frame: Baseline up to 5 years ]
  Will summarize each of the quality of life instruments Satisfaction with Decision(SWD)Scale using tabulations, descriptive statistics, and boxplots at each evaluation time. Will estimate the mean score for each instrument at each evaluation time with a 95% confidence interval. Satisfaction with Decision (SWD) Scale: The Satisfaction with Decision scale is a six-item survey that measures the patient's satisfaction with health care decisions. The instrument has been shown to have excellent reliability and validity [26].
• Proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent in sentinel lymph nodes [ Time Frame: Up to 5 years ]
  Will classify each patient as having metastases present, micrometastases present, isolated tumor cells present, or no tumor present according to the histopathology of the sentinel lymph nodes. Will tabulate the number and percent of patients in each of these 4 categories. Will estimate the proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent with 95% confidence intervals.

• Original Primary Outcome Measures (submitted: January 12, 2010): Immediate Failure Rate [ Time Frame: 5 Years ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: January 12, 2010): Cervix Cancer Recurrence Rate [ Time Frame: At 2 Years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
• Official Title: Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• 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

Intervention

• Procedure: Lymph Node Mapping
  Undergo lymphatic mapping with sentinel lymph node biopsy
  Other Name: lymphatic mapping
• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment
• Procedure: Salpingo-Oophorectomy
  Undergo hysterectomy with or without salpingo-oophorectomy
• Procedure: Sentinel Lymph Node Biopsy
  Undergo lymphatic mapping with sentinel lymph node biopsy
  Other Names:

  • Sentinel Node Biopsy
  • Sentinel node biopsy alone
  • SLNB
  • SNB
• Procedure: Therapeutic Conventional Surgery
  Undergo hysterectomy with or without salpingo-oophorectomy

Study Arms

Experimental: Treatment (conservative surgery)

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.

Interventions:

• Procedure: Lymph Node Mapping
• Other: Quality-of-Life Assessment
• Procedure: Salpingo-Oophorectomy
• Procedure: Sentinel Lymph Node Biopsy
• Procedure: Therapeutic Conventional Surgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 26, 2022): 137
• Original Estimated Enrollment (submitted: January 12, 2010): 100
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Brazil, Colombia, Mexico, Peru, Thailand, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01048853
• Other Study ID Numbers: 2008-0118; NCI-2012-01254 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 2008-0118 ( Other Identifier: M D Anderson Cancer Center )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Kathleen Schmeler, MD / Professor, UT MD Anderson Cancer Center
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kathleen M Schmeler; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: April 2023