Back to resultsPost-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
Primary Purpose
Head and Neck Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Iressa (Gefitinib)
chemoradiotherapy with cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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)
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
postop chemoradio with cisplatin
postop chemoradio (cisplatin)+gefitinib
Arm Description
postoperative chemoradiotherapy with cisplatin
postoperative chemoradiotherapy with cisplatin + gefitinib
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00169221
First Posted
September 12, 2005
Last Updated
November 14, 2011
Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00169221
Brief Title
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Collaborators
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postop chemoradio with cisplatin
Arm Type
Active Comparator
Arm Description
postoperative chemoradiotherapy with cisplatin
Arm Title
postop chemoradio (cisplatin)+gefitinib
Arm Type
Experimental
Arm Description
postoperative chemoradiotherapy with cisplatin + gefitinib
Intervention Type
Drug
Intervention Name(s)
Iressa (Gefitinib)
Intervention Description
postoperative chemoradiotherapy with cisplatin + gefitinib
Intervention Type
Radiation
Intervention Name(s)
chemoradiotherapy with cisplatin
Intervention Description
postoperative chemoradiotherapy with cisplatin
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene-Jean Bensadoun, MD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22855581
Citation
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.
Results Reference
derived
Learn more about this trial
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
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