Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00169221
• Other study ID #: GORTEC 2004-02
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 14, 2011
• Start date: September 2005
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: July 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Iressa (Gefitinib)
postoperative chemoradiotherapy with cisplatin + gefitinib

Radiation:
• chemoradiotherapy with cisplatin
postoperative chemoradiotherapy with cisplatin

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		3 years	No