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Surgical Interventions for Cervical Cancer

N/A

Waitlist Available

Led By Allan L Covens

Research Sponsored by Gynecologic Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how surgery for early-stage cervical cancer affects patients' quality of life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not directly related to side effects from medication, surgical interventions may include risks such as infection, bleeding, pain at the surgery site, possible damage to nearby organs or tissues, and lymphedema.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)

Change in sexual function and activity based on Female Sexual Function Index (19 items) score plus 2 Patient Reported Outcomes Measurement Information System screener items

Lymphedema

+1 more

Secondary study objectives

Change in cancer worries based on Impact of Events score

Change in overall quality of life

Change in reproductive concerns based on reproductive concerns (14 items) score

+4 more