Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003627
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
1999-11-01
Brief Title:
Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Advanced Cancer of the Oropharynx or Hypopharynx
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase III Randomized Study of Radiotherapy With or Without Cisplatin and Fluorouracil for Locally Advanced Nonresectable Squamous Cell Cancer of the Oropharynx or Hypopharynx
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die 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 whether radiation therapy with combination chemotherapy is more effective than radiation therapy alone in treating cancer of the oropharynx or hypopharynx that cannot be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin and fluorouracil with radiation therapy alone in treating patients who have advanced cancer of the oropharynx or hypopharynx that cannot be surgically removed
Detailed Description:
OBJECTIVES
Compare the overall survival and survival without relapse for 1 3 and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil
Compare the presence of distant metastases at 1 3 and 5 years in these patients after these treatments
Compare the local control and duration of control in these patients after these treatments
Compare the clinical changes and histological changes at 6 months in these patients after these treatments
Determine the rate of complete response in these patients after these treatments
Determine the early and late toxic effects of these regimens in these patients
Determine the quality of life of these patients
Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center and primary site of disease oropharynx vs hypopharynx
Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy twice a day 6 hours apart 5 days a week for 7 weeks
Arm II Patients undergo radiotherapy as in arm I plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5 Courses are repeated every 3 weeks for 3 courses
Patients are followed every month for 1 year every 2-3 months for 2 years then every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 160 patients 80arm will be accrued for this study within 45 years
Compare the overall survival and survival without relapse for 1 3 and 5 years of patients with squamous cell cancer of the oropharynx or hypopharynx after treatment with twice a day radiotherapy with or without cisplatin and fluorouracil
Compare the presence of distant metastases at 1 3 and 5 years in these patients after these treatments
Compare the local control and duration of control in these patients after these treatments
Compare the clinical changes and histological changes at 6 months in these patients after these treatments
Determine the rate of complete response in these patients after these treatments
Determine the early and late toxic effects of these regimens in these patients
Determine the quality of life of these patients
Determine the pharmacokinetics of fluorouracil and tolerability of this regimen in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center and primary site of disease oropharynx vs hypopharynx
Patients are randomized to one of two treatment arms
Arm I Patients undergo radiotherapy twice a day 6 hours apart 5 days a week for 7 weeks
Arm II Patients undergo radiotherapy as in arm I plus concurrent chemotherapy consisting of cisplatin IV on day 1 and fluorouracil by continuous infusion over 24 hours on days 1-5 Courses are repeated every 3 weeks for 3 courses
Patients are followed every month for 1 year every 2-3 months for 2 years then every 6 months for at least 2 years
PROJECTED ACCRUAL A total of 160 patients 80arm will be accrued for this study within 45 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98027 | None | None | None |
| FRE-FNCLCC-96003 | None | None | None |