Surgical Interventions for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+185 other locations

Overseen by Allan L Covens

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Gynecologic Oncology Group

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical 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.

Research Team

Allan L Covens

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with early-stage cervical cancer (stage IA1 with LVSI+, IA2, IB1 with tumor ≤2cm). They must have had a cone biopsy or LEEP showing invasion ≤10mm and no metastasis on scans. Participants need to consent to surgery, have good performance status (0-2), and sign informed consent.

Inclusion Criteria

Patients who have met the pre-entry requirements

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

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

Treatment Details

Interventions

• Conization (Surgery)
• Quality-of-Life Assessment (Behavioural Intervention)
• Questionnaire Administration (Behavioural Intervention)
• Therapeutic Conventional Surgery (Surgery)
• Therapeutic Lymphadenectomy (Surgery)

Trial Overview The study focuses on the impact of surgery on physical function and quality of life in stage I cervical cancer patients. It involves assessments through questionnaires before and after surgical procedures like conization, lymphadenectomy, and other conventional surgeries.

Participant Groups

Group I: Treatment (cone biopsy/lymphadenectomy or hysterectomy) Experimental Treatment 5 Interventions

Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.

Who Is Running the Clinical Trial?

Gynecologic Oncology Group

Lead Sponsor

Trials

251

Recruited

65,400+

Dr. Larry J. Copeland

Gynecologic Oncology Group

Chief Medical Officer since 2017

MD from The Ohio State University

Dr. Thomas J. Herzog

Gynecologic Oncology Group

Chief Executive Officer since 2023

MD from University of Cincinnati

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School