|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
AstraZeneca |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00681967 |
Purpose
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
| Condition | Intervention | Phase |
|
Head and Neck Cancer |
Drug: Gefitinib |
Phase I |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| ChemIDplus related topics: | Cisplatin ZD1839 Tyrosine Triiodothyronine Liothyronine sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial |
| Enrollment: | 31 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Cohort 1: Experimental
post operative combination of gefinib and RT
|
Drug: Gefitinib
250 mg; oral
|
|
Cohort 2: Experimental
combination of gefitinib with RT and Chemotherapy in non operated patients
|
Drug: Gefitinib
250mg; oral
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland | |||||
| Research Site | |||||
| Basel, Switzerland | |||||
| Research Site | |||||
| Bern, Switzerland | |||||
| AstraZeneca |
| Principal Investigator: | Christoph Rochlitz, Prof Dr med | University Hospital of Basel |
| Study Director: | Madeleine Billeter, MD | AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland |
| Study Chair: | Verena Renggli | AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland |
More Information
| Responsible Party: | AstraZeneca AG Switzerland ( Madeleine Billeter, MD, Medical & Regulatory Affairs Director ) |
| Study ID Numbers: | 1839IL/0525 |
| First Received: | May 20, 2008 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00681967 |
| Health Authority: | Switzerland: Swissmedic |
|
|
|
|
|
|