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

M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

Cervical Adenocarcinoma

Stage IB1 Cervical Cancer AJCC V6 and V7

Cervical Squamous Cell Carcinoma, Not Otherwise Specified

Stage IA2 Cervical Cancer AJCC V6 and V7

Treatments

Procedure: Salpingo-Oophorectomy

Other: Quality-of-Life Assessment

Procedure: Lymph Node Mapping

Procedure: Therapeutic Conventional Surgery

Procedure: Sentinel Lymph Node Biopsy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01048853

NCI-2012-01254 (Registry Identifier)

2008-0118

Details and patient eligibility

About

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.

Full 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.

Enrollment

137 patients

Sex

Female

Volunteers

No 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)