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Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer

Status: Recruiting
Phase: N/A
Diagnosis: GYN: Cervical Cancer
NCT ID: NCT01649089 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-252

 

This trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Colleen Feltmate, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - Patient must consent for the appropriate surgery - Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade - All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (loop electrosurgical excision [LEEP]) and had negative margins for carcinoma and high-grade dysplasia; depth of invasion must be =< 10 mm - Patients must have no evidence of metastasis on magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging - Patients who have met the pre-entry requirements - Patients must have signed an approved informed consent and authorization permitting release of personal health information - Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 Exclusion Criteria: - Patients with Stage IA1 disease who are LVSI negative - Patients with Stage IB1 with tumor size (maximum visible or palpable) > 2 cm - Patients with >= stage IB2 disease - Patients with clear cell or neuroendocrine cell types - Patients with depth of invasion > 10mm on first cone biopsy (or LEEP) - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
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