Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
18 Years
80 Years
Both
Anal Cancer
Trial Information
Phase II Nonrandomized Multicenter Study of the Impact of Radiochemotherapy (65 Gy + Cisplatin + 5FU) Combined With Cetuximab in Patients Presenting With Locally Advanced Anal Cancer
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) 8 weeks after completion of
study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and
cetuximab followed by additional radiotherapy in patients with locally advanced anal
cancer.
Secondary
- Evaluate colostomy-free survival.
- Evaluate the local control rate (objective response and stabilization) at 8 weeks.
- Evaluate relapse-free survival at 5 years.
- Evaluate the intermediate objective response at the end of week 5 of radiotherapy.
- Evaluate overall survival at 5 years.
- Evaluate the duration of response.
- Evaluate acute toxicities according to CTCAE v3.0.
- Evaluate late toxicities at 5 years according to CTCAE v3.0.
- Study the tumor markers associated with response (survival without relapse) and
toxicity.
- Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their
association with skin toxicity, objective survival, and relapse-free survival.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10
and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also
undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this
treatment, patients undergo additional radiotherapy* 5 days a week for 2 weeks (weeks 9 and
10).
NOTE: *Some patients may undergo brachytherapy.
Blood and tissue samples are collected for further analysis.
After completion of study treatment, patients are followed up for 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed anal cancer
- Squamous cell disease
- Locally advanced, non-metastatic disease
- One of the following clinical TNM stages:
- T2, N0, M0 (largest diameter ≥ 3 cm)
- T3-T4, N0, M0
- Any T, N1-N3, M0
- No undifferentiated small cell carcinoma or adenocarcinoma
- Measurable disease according to RECIST criteria
- Undergone endorectal ultrasound or MRI to evaluate the primary tumor
- Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension
- Disease suitable to receive radiotherapy and chemotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Leukocytes ≥ 4,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Creatinine clearance > 60 mL/min
- ALT and AST ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No history of cancer within the past 8 years except for in situ cervical cancer or
previously treated basal cell carcinoma of the skin
- No contraindications to any component of study therapy
- No serious uncontrolled illness
- No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2
- No congestive heart failure
- No peripheral sensory neuropathy
- No uncontrolled diabetes
- No HIV positivity
- No geographical, social, or psychological situations that preclude medical follow up
- Affiliated with a social security system
- No patient deprived of liberty or under trusteeship
PRIOR CONCURRENT THERAPY:
- Patients with a diverting colostomy are eligible
- No prior excision of this tumor
- No prior chemotherapy or radiotherapy for the treatment of this cancer or any other
history of radiotherapy or pelvic brachytherapy
- No concurrent coumarin anticoagulants, phenytoin, sorivudine or brivudine, antacids,
or allopurinol
- Not registered in another clinical trial with an experimental drug
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment
Safety Issue:
No
Principal Investigator
Eric Deutsch, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
CDR0000642638
NCT ID:
NCT00955240
Start Date:
March 2009
Completion Date:
Related Keywords:
- Anal Cancer
- stage II anal cancer
- stage IIIA anal cancer
- stage IIIB anal cancer
- squamous cell carcinoma of the anus
- Anus Neoplasms
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