Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
- Determine the response rate, in terms of clinical or radiologic response at 12 weeks
after completion of study therapy, in patients with stage IB2-IVA cervical cancer
treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin
followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy.
- Determine the response rate in patients treated with this neoadjuvant chemotherapy
- Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients.
- Assess the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemotherapy: Patients receive neoadjuvant chemotherapy comprising
paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment
repeats weekly for up to 6 courses in the absence of disease progression or
- Chemoradiotherapy: Beginning in week 7, or as soon as blood counts recover, patients
receive cisplatin IV over 1 hour on day 1. Treatment repeats weekly for 4-6 courses in
the absence of disease progression or unacceptable toxicity. Patients also undergo
concurrent radiotherapy comprising pelvic external beam radiotherapy once daily for 5½
weeks (5 weeks for patients with positive para-aortic lymph nodes) and 2 applications
of high-dose rate intracavitary brachytherapy or low- or medium-dose rate
brachytherapy. Patients with parametrial or pelvic sidewall disease extension also
undergo external boost radiotherapy for 3 days.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)
Mary McCormack, MD
University College London Hospitals