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

Trial Information

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

OBJECTIVES:

Primary

- To determine if the addition of adjuvant chemotherapy to standard cisplatin-based
chemoradiation improves overall survival.

Secondary

- To determine the progression-free survival rates.

- To determine acute and long-term toxicities.

- To determine patterns of disease recurrence.

- To determine the association between radiation protocol compliance and outcomes.

- To determine patient quality of life, including psycho-sexual health.

Tertiary

- To determine the association between the results of a follow-up PET scan performed 4 -
6 months post completion of chemoradiation and outcomes for all patients in the trial.

- To determine the biological predictors of patients' outcomes based on translational
laboratory studies of blood and tissue specimens.

OUTLINE: This is a multicenter study. Patients are stratified according to pelvic or common
iliac nodal involvement (yes vs no), requirement for extended-field radiotherapy treatment
(yes vs no), FIGO stage (IB/IIA vs IIB vs IIIB/IVA), age (< 60 years of age vs ≥ 60 years of
age), and hospital/site. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin 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 therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.