Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
NCT00002839 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 564
Last updated 2018-07-09
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells and allow doctors to preserve the part of the body where the cancer started. It is not yet known which regimen of cisplatin and fluorouracil combined with radiation therapy is more effective in treating resectable cancer of the hypopharynx or larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of cisplatin and fluorouracil combined with radiation therapy in preserving the larynx in patients who have resectable cancer of the hypopharynx or larynx.
Conditions
Interventions
- DRUG
- DRUG
- PROCEDURE
-
conventional surgery
- PROCEDURE
-
neoadjuvant therapy
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
European Organisation for Research and Treatment of Cancer - EORTC
lead NETWORK
Principal Investigators
-
Jean-Louis Lefebvre, MD · Centre Oscar Lambret
-
Jean-Claude Horiot, MD, PhD · Centre Georges Francois Leclerc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1996-07-31
- Primary Completion
- 2004-05-31
Countries
- Belgium
- France
- Israel
- Italy
- Netherlands
- Switzerland
Study Locations
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