Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
18 Years
N/A
Female
Cervical Cancer
Trial Information
Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed carcinoma of the cervix, including any of the following
subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Adenosquamous cell carcinoma
- Locally advanced disease (i.e., FIGO stage IB2-IVA disease)
- Stage confirmed by examination under anesthesia, cystoscopy, and sigmoidoscopy
with biopsy of any suspicious lesions in the bladder, vagina, or rectum
- Disease suitable for treatment with radical intent using chemoradiotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Platelet count > 100,000/mm^3
- Hemoglobin > 12.5 g/dL
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Bilirubin < 1.25 times upper limit of normal (ULN)
- Glomerular filtration rate (GFR) normal by ethylenediaminetetraacetic acid (EDTA) OR
creatinine clearance ≥ 60 mL/min
- Placement of ureteric stents required for all patients with hydronephrosis,
regardless of renal function
- ALT or AST < 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No prior diagnosis of cancer, except basal cell skin cancer
- No active cardiac disease
- Deemed fit to receive chemoradiotherapy
- ECG normal
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)
Safety Issue:
No
Principal Investigator
Mary McCormack, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
Unspecified
Study ID:
CDR0000540233
NCT ID:
NCT00462397
Start Date:
June 2005
Completion Date:
Related Keywords:
- Cervical Cancer
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- cervical squamous cell carcinoma
- stage IB cervical cancer
- stage IIA cervical cancer
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- recurrent cervical cancer
- Uterine Cervical Neoplasms
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