NCT01649089|Active Not RecruitingDMC

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

Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer

GOG Foundation ClinicalTrials.gov

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6 other identifiers

GOG-0278NCI-2012-01990CDR0000737208U10CA101165U10CA180868UG1CA189867

Study Type

interventional

Target

224

Locations

3 countries

Sites

185

Timeline

RegisteredJul 2012

StartedJun 2013

CompletionDec 2025

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

224

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach

3 countries

185 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.5 years study duration

First Submitted

Initial submission to the registry

July 21, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed

11 months until next milestone

Study Start

First participant enrolled

June 5, 2013

Completed

11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed

Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

11.5 years

First QC Date

July 21, 2012

Last Update Submit

May 2, 2024

Conditions

Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Lymphedema Stage IA1 Cervical Cancer AJCC v6 and v7 Stage IA2 Cervical Cancer AJCC v6 and v7 Stage IB1 Cervical Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (4)

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)
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Baseline to 3 years
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
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Baseline to 3 years
Lymphedema
Based on Cancer Lymphedema Questionnaire score.
Up to 3 years
Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema
Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
Up to 3 years after non-radical surgical procedure

Secondary Outcomes (7)

Maximum grade of treatment-related adverse events
Up to 30 days after surgical procedure
Change in overall quality of life
Baseline to 3 years
Change in cancer worries based on Impact of Events score
Baseline to 3 years
Change in reproductive concerns based on reproductive concerns (14 items) score
Baseline to 3 years
Site of first recurrence
Up to 3 years
+2 more secondary outcomes

Study Arms (1)

Treatment (cone biopsy/lymphadenectomy or hysterectomy)

EXPERIMENTAL

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

Procedure: ConizationOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationProcedure: Therapeutic Conventional SurgeryProcedure: Therapeutic Lymphadenectomy

Interventions

ConizationPROCEDURE

Undergo cone biopsy

Also known as: cone biopsy, Cone Biopsy of Cervix, Conization of Cervix, Conization of Uterine Cervix