Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002839
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy To Preserve the Larynx in Patients With Cancer of the Hypopharynx or Larynx
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PHASE II STUDY ON LARYNX PRESERVATION COMPARING INDUCTION CHEMOTHERAPY AND RADIOTHERAPY VERSUS ALTERNATING CHEMO-RADIOTHERAPY IN RESECTABLE HYPOPHARYNX AND LARYNX CANCERS
Status:
COMPLETED
Status Verified Date:
2018-07
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 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
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
Detailed Description:
OBJECTIVES
Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy
Compare the health-related quality of life in patients treated with these regimens
Compare the cost-effectiveness of these regimens
OUTLINE This is a randomized multicenter study Patients are stratified by performance status disease site tumor stage node stage and center
Patients are randomized to one of two treatment arms Both groups may receive either conventional radiotherapy in single daily fractions 5 days per week for 7 weeks option 1 or hyperfractionated radiotherapy in 2 daily fractions 5 days per week for 4-5 weeks option 2 according to institutional policy
Arm I Patients receive cisplatin and fluorouracil every 3 weeks Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80 After radiotherapy patients with a complete remission enter follow-up those with a partial remission proceed to surgery Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy
Arm II Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy those with a complete remission enter follow-up while all others proceed to surgery Patients treated on option 2 are evaluated on day 42 those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7
Patients are followed every 3 months for 3 years and at least every 6 months thereafter
PROJECTED ACCRUAL A total of 564 patients will be accrued for this study within 4 years
Compare relapse-free survival and larynx preservation in patients with resectable hypopharyngeal or laryngeal cancer treated with sequential vs alternating cisplatin and fluorouracil and radiotherapy
Compare the health-related quality of life in patients treated with these regimens
Compare the cost-effectiveness of these regimens
OUTLINE This is a randomized multicenter study Patients are stratified by performance status disease site tumor stage node stage and center
Patients are randomized to one of two treatment arms Both groups may receive either conventional radiotherapy in single daily fractions 5 days per week for 7 weeks option 1 or hyperfractionated radiotherapy in 2 daily fractions 5 days per week for 4-5 weeks option 2 according to institutional policy
Arm I Patients receive cisplatin and fluorouracil every 3 weeks Patients with a complete or partial response on day 42 receive 2 additional courses of chemotherapy followed by 7 weeks of radiotherapy beginning on day 80 After radiotherapy patients with a complete remission enter follow-up those with a partial remission proceed to surgery Patients with stable or progressive disease proceed immediately to surgery with or without postoperative radiotherapy
Arm II Patients receive cisplatin and fluorouracil every 3 weeks for 4 courses Patients treated on radiotherapy option 1 are evaluated 2 months after completion of radiotherapy those with a complete remission enter follow-up while all others proceed to surgery Patients treated on option 2 are evaluated on day 42 those with a partial or complete response complete chemoradiotherapy and are then evaluated and treated like option 1 patients Patients with stable or progressive disease on day 42 proceed to surgery with or without a third course of chemotherapy on week 7
Patients are followed every 3 months for 3 years and at least every 6 months thereafter
PROJECTED ACCRUAL A total of 564 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None