Cervical Cancer Clinical Trial
Official title:
Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with
carboplatin followed by cisplatin and radiation therapy works in treating patients with
stage IB, stage II, stage III, or stage IVA cervical cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the response rate in patients treated with this neoadjuvant chemotherapy
regimen.
- 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
unacceptable toxicity.
- 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
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