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

NCT00169221 | Terminated Phase 2

• 1 other identifier: GORTEC 2004-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  3 years

Study Arms (2)

postop chemoradio with cisplatin

ACTIVE COMPARATOR

postoperative chemoradiotherapy with cisplatin

Radiation: chemoradiotherapy with cisplatin

postop chemoradio (cisplatin)+gefitinib

EXPERIMENTAL

postoperative chemoradiotherapy with cisplatin + gefitinib

Drug: Iressa (Gefitinib)

Interventions

Iressa (Gefitinib) DRUG

postoperative chemoradiotherapy with cisplatin + gefitinib

postop chemoradio (cisplatin)+gefitinib

chemoradiotherapy with cisplatin RADIATION

postoperative chemoradiotherapy with cisplatin

postop chemoradio with cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• AstraZeneca: collaborator

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Thariat J, Bensadoun RJ, Etienne-Grimaldi MC, Grall D, Penault-Llorca F, Dassonville O, Bertucci F, Cayre A, De Raucourt D, Geoffrois L, Finetti P, Giraud P, Racadot S, Moriniere S, Sudaka A, Van Obberghen-Schilling E, Milano G. Contrasted outcomes to gefitinib on tumoral IGF1R expression in head and neck cancer patients receiving postoperative chemoradiation (GORTEC trial 2004-02). Clin Cancer Res. 2012 Sep 15;18(18):5123-33. doi: 10.1158/1078-0432.CCR-12-1518. Epub 2012 Aug 1.

  PMID: 22855581 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Gefitinib; Chemoradiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Rene-Jean Bensadoun, MD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2011
• Last Updated: November 15, 2011

Record last verified: 2011-11

Locations

FR (1)