A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial
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 locally
advanced cervical cancer. Drugs used in chemotherapy, such as cisplatin, carboplatin, and
paclitaxel, work in different ways to stop the growth of tumour cells, either by killing the
cells or by stopping them from dividing. External radiation therapy uses high-energy x rays
to kill tumour cells. Internal radiation uses radioactive material placed directly into or
near a tumour to kill tumour cells. It is not yet known whether giving cisplatin and external
and internal radiation therapy together with carboplatin and paclitaxel kills more tumour
- Patterns of disease recurrence
- Progression-free survival rate
- Progression-free survival rate
- Quality of life including psychosexual health
- Radiation protocol compliance
- Rate of acute and long-term toxicities
I. To determine if the addition of adjuvant chemotherapy to standard cisplatin-based
chemoradiation improves overall survival.
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.
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.
This is a multicentre study. Patients are stratified according to pelvic or common
iliac nodal involvement (yes vs no), requirement for extended-field radiation therapy treatment
(yes vs no), International Federation of Gynecology and Obstetrics (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 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 tumour biopsy and blood collection for future correlative
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.
View this trial on ClinicalTrials.gov