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Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 7, 2009
Last updated: July 8, 2011
Last verified: July 2011

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Condition Intervention Phase
Anal Cancer
Biological: cetuximab
Drug: cisplatin
Drug: fluorouracil
Other: laboratory biomarker analysis
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Secondary Outcome Measures:
  • Survival rate at 3 and 5 years
  • Colostomy-free survival at 3 and 5 years
  • Duration of objective response

Estimated Enrollment: 77
Study Start Date: March 2009
Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00955240

Institut Bergonie
Bordeaux, France, 33076
CHU Hopital A. Morvan
Brest, France, 29609
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Leon Berard
Lyon, France, 69373
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie Hopital
Paris, France, 75248
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Hopital Charles Nicolle
Rouen, France, 76031
Centre Hospitalier Prive Saint-Gregoire
Saint-Gregoire, France, 35768
Clinique Du Parc
Toulouse, France, 31078
Groupe Oncorad Garonne
Toulouse, France, 31300
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
Principal Investigator: Eric Deutsch, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00955240     History of Changes
Other Study ID Numbers: CDR0000642638
EUDRACT-2007-0 07029-38
Study First Received: August 7, 2009
Last Updated: July 8, 2011

Keywords provided by National Cancer Institute (NCI):
stage II anal cancer
stage IIIA anal cancer
stage IIIB anal cancer
squamous cell carcinoma of the anus

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017