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

Primary Purpose

Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IA2 Cervical Cancer AJCC v6 and v7

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lymph Node Mapping
Quality-of-Life Assessment
Salpingo-Oophorectomy
Sentinel Lymph Node Biopsy
Therapeutic Conventional Surgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Adenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Baptist MD Anderson Cancer Center
  • Nebraska Methodist Hospital
  • MD Anderson Cancer Center at Cooper-Voorhees
  • Northwell Health Imbert Cancer Center
  • Lyndon Baines Johnson General Hospital
  • M D Anderson Cancer Center
  • The Woman's Hospital of Texas
  • MD Anderson in Katy
  • MD Anderson League City
  • MD Anderson in Sugar Land
  • MD Anderson in The Woodlands
  • Hospital Italiano of Buenos Aires
  • Hospital Israelita Buenos Aires
  • Instituto de Oncologia Angel H Roffo
  • Royal Women's Hosptial
  • Hosptial de Cancer de Barretos
  • Instituto Nacional De Cancerologia
  • Instituto Nacional De Cancerologia de Mexico
  • Instituto Nacional de Enfermedades Neoplasicas
  • King Chulalongkorn University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (conservative surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%.
Recurrence rate
Will estimate with an exact 95% binomial confidence interval.
Short Form Health Survey SF-12 Questionnaires
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
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
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
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2010
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01048853
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2009 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (conservative surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lymph Node Mapping
Other Intervention Name(s)
lymphatic mapping
Intervention Description
Undergo lymphatic mapping with sentinel lymph node biopsy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Salpingo-Oophorectomy
Intervention Description
Undergo hysterectomy with or without salpingo-oophorectomy
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Other Intervention Name(s)
Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Intervention Description
Undergo lymphatic mapping with sentinel lymph node biopsy
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo hysterectomy with or without salpingo-oophorectomy
Primary Outcome Measure Information:
Title
Feasibility of study treatment by determining the immediate failure rate, defined as residual disease in the sample hysterectomy specimen
Description
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%.
Time Frame
Up to 7 days
Title
Recurrence rate
Description
Will estimate with an exact 95% binomial confidence interval.
Time Frame
2 years
Title
Short Form Health Survey SF-12 Questionnaires
Description
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]
Time Frame
Baseline up to 5 years
Title
Functional Assessment of Cancer Therapy-Cervix [FACT-CX] Questionnaires
Description
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.
Time Frame
Baseline up to 5 years
Title
MD Anderson Symptom Inventory MDASI Questionnaires
Description
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].
Time Frame
Baseline up to 5 years
Title
Female Sexual Functioning Index (FSFI) Questionnaires
Description
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
Time Frame
Baseline up to 5 years
Title
Satisfaction with Decision(SWD)Scale Questionnaires
Description
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].
Time Frame
Baseline up to 5 years
Title
Proportion of patients identified with metastases present, micrometastases present, isolated tumor cells, and tumor absent in sentinel lymph nodes
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Schmeler
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper-Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Northwell Health Imbert Cancer Center
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026-1967
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Woman's Hospital of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
MD Anderson in Katy
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
MD Anderson League City
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
MD Anderson in Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
MD Anderson in The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Hospital Italiano of Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1181
Country
Argentina
Facility Name
Hospital Israelita Buenos Aires
City
Buenos Aires
ZIP/Postal Code
1407
Country
Argentina
Facility Name
Instituto de Oncologia Angel H Roffo
City
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
Royal Women's Hosptial
City
Victoria
State/Province
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Hosptial de Cancer de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784
Country
Brazil
Facility Name
Instituto Nacional De Cancerologia
City
Bogota
ZIP/Postal Code
99999
Country
Colombia
Facility Name
Instituto Nacional De Cancerologia de Mexico
City
Mexico City
State/Province
Tlalpan
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
King Chulalongkorn University
City
Bangkok
State/Province
Pathumwan
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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