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CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas


Inclusion Criteria:



- Patients with upper aerodigestive tract carcinomas (all sites included) having
surgical resection and eligible for post-operative radiation + cisplatin.

- Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of
surgical resection (patients with small tumors located in larynx for instance will
not be included)

- Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical
area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria:

- previous history of cancer (except skin basal cell carcinoma)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Rene-Jean Bensadoun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GORTEC 2004-02

NCT ID:

NCT00169221

Start Date:

September 2005

Completion Date:

July 2011

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma
  • Head and Neck Neoplasms

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