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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cone biopsy/lymphadenectomy or hysterectomy)Experimental Treatment5 Interventions
Patients undergo cone biopsy and pelvic lymphadenectomy or simple hysterectomy and pelvic lymphadenectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Conization
1998
N/A
~690
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870

Find a Location

Who is running the clinical trial?

Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
71,162 Total Patients Enrolled
4 Trials studying Lymphedema
1,177 Patients Enrolled for Lymphedema
GOG FoundationLead Sponsor
45 Previous Clinical Trials
17,210 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,177 Total Patients Enrolled
31 Trials studying Lymphedema
14,106 Patients Enrolled for Lymphedema

Media Library

Therapeutic Conventional Surgery Clinical Trial Eligibility Overview. Trial Name: NCT01649089 — N/A
Lymphedema Research Study Groups: Treatment (cone biopsy/lymphadenectomy or hysterectomy)
Lymphedema Clinical Trial 2023: Therapeutic Conventional Surgery Highlights & Side Effects. Trial Name: NCT01649089 — N/A
Therapeutic Conventional Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01649089 — N/A
Lymphedema Patient Testimony for trial: Trial Name: NCT01649089 — N/A
~7 spots leftby Dec 2024