Trials / Completed

CompletedNCT01414608

Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial

Status: Completed
Phase: Phase 3
Study type: Interventional
Enrollment: 926 (actual)

Sponsor: GOG Foundation · Network
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with cervical cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of \[cancer/tumor\] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. External radiation therapy uses high-energy x rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kills more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival. SECONDARY OBJECTIVES: I. To determine the progression-free survival rates. II. To determine acute and long-term toxicities. III. To determine patterns of disease recurrence. IV. To determine the association between radiation protocol compliance and outcomes. V. To determine patient quality of life, including psycho-sexual health. TERTIARY OBJECTIVES: I. To determine the association between the results of a follow-up positron emission tomography (PET) scan performed 4-6 months post completion of chemoradiation and outcomes for all patients in the trial. II. To determine the biological predictors of patients' outcomes based on translational laboratory studies of blood and tissue specimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cisplatin intravenously (IV) over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate, pulsed-dose rate, or low-dose rate intracavitary brachytherapy. ARM II: Patients receive cisplatin and undergo external-beam radiation and brachytherapy as in arm I. Beginning 4 weeks later, patients also receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo baseline tumor biopsy and blood collection for future correlative studies. Patients complete the European Organization for Research and Treatment of Cancer (EORTC) Core questionnaire (QLQ-C30), the EORTC cervix cancer module (CX24), the ovarian cancer module (OV28), and the Sexual function-Vaginal Changes Questionnaire (SVQ) questionnaires at baseline, during, and after completion of study treatment. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

Type	Name	Description
RADIATION	Brachytherapy	Undergo brachytherapy
DRUG	Carboplatin	Given IV
DRUG	Cisplatin	Given IV
RADIATION	External Beam Radiation Therapy	Undergo external beam radiation therapy
DRUG	Paclitaxel	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2012-01-09
Primary completion: 2021-07-09
Completion: 2021-07-09
First posted: 2011-08-11
Last updated: 2022-11-07
Results posted: 2022-11-07

Locations

326 sites across 5 countries: United States, Canada, China, Saudi Arabia, Singapore

Source: ClinicalTrials.gov record NCT01414608. Inclusion in this directory is not an endorsement.