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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

Phase 2
18 Years
80 Years
Open (Enrolling)
Anal Cancer

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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



- 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


- 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

- 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

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


- 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


- 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


- 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:


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:


Principal Investigator

Eric Deutsch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




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