Conservative Surgery in Treating Patients With Low-Risk Stage IA2 or IB1 Cervical Cancer
NCT ID: NCT01048853
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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TERMINATED
NA
137 participants
INTERVENTIONAL
2010-04-15
2025-12-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Lymph Node Mapping
Undergo lymphatic mapping with sentinel lymph node biopsy
Quality-of-Life Assessment
Ancillary studies
Salpingo-Oophorectomy
Undergo hysterectomy with or without salpingo-oophorectomy
Sentinel Lymph Node Biopsy
Undergo lymphatic mapping with sentinel lymph node biopsy
Therapeutic Conventional Surgery
Undergo hysterectomy with or without salpingo-oophorectomy
Interventions
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Lymph Node Mapping
Undergo lymphatic mapping with sentinel lymph node biopsy
Quality-of-Life Assessment
Ancillary studies
Salpingo-Oophorectomy
Undergo hysterectomy with or without salpingo-oophorectomy
Sentinel Lymph Node Biopsy
Undergo lymphatic mapping with sentinel lymph node biopsy
Therapeutic Conventional Surgery
Undergo hysterectomy with or without salpingo-oophorectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kathleen M Schmeler
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
The Woman's Hospital of Texas
Houston, Texas, United States
MD Anderson in Katy
Houston, Texas, United States
MD Anderson League City
Nassau Bay, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
MD Anderson in The Woodlands
The Woodlands, Texas, United States
Hospital Italiano of Buenos Aires
Buenos Aires, , Argentina
Hospital Israelita Buenos Aires
Buenos Aires, , Argentina
Instituto de Oncologia Angel H Roffo
Buenos Aires, , Argentina
Royal Women's Hosptial
Melbourne, Victoria, Australia
Hosptial de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto Nacional De Cancerologia
Bogotá, , Colombia
Instituto Nacional De Cancerologia de Mexico
Mexico City, Tlalpan, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
King Chulalongkorn University
Bangkok, Pathumwan, Thailand
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2012-01254
Identifier Type: REGISTRY
Identifier Source: secondary_id
2008-0118
Identifier Type: OTHER
Identifier Source: secondary_id
2008-0118
Identifier Type: -
Identifier Source: org_study_id
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