RTOG-0724

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Principal Investigator

Anuja Jhingran

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine if adjuvant systemic chemotherapy following chemoradiation therapy will improve disease-free survival compared to chemoradiation therapy alone in patients with high-risk earlystage cervical carcinoma found to have positive nodes and/or positive parametria after a radical hysterectomy.

Protocol and Other Documents:

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

Patient Population:

Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery (this corresponds to surgical TNM staging of T1-T2, N1, M0): 

Positive pelvic nodes

Positive parametrium

Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)

Dual Enrollment to RTOG 0724 and RTOG 1203

Patients are permitted to be enrolled onto both RTOG 0724 and RTOG 1203, however careful consideration must be made to the following:

 
• In order to avoid protocol deviations, patients MUST be registered to 1203 first. The treatment arm that the patient is assigned to on 1203 will be the same treatment option used for stratification in 0724.

 

• Patients MUST meet eligibility criteria for both studies.

 

• The radiation guidelines (Section 6) in 1203 should be followed for BOTH studies.

 

Target Accrual

285