Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008047
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy Combined With Radiation Therapy in Treating Patients Who Have Stage II or Stage III Cancer of the Esophagus
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multicentre Phase II Study Of Concomitant Radio-Chemotherapy Associating Continuous Infusion 5-FU With Hydroxyuree Via Bone Marrow With Or Without Paclitaxel In Treatment Of Inoperable Epidermoid Carcinoma Of Esophagus
Status:
UNKNOWN
Status Verified Date:
2001-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy with or without paclitaxel combined with radiation therapy in treating patients who have stage II or stage III cancer of the esophagus
Detailed Description:
OBJECTIVES
Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with or without paclitaxel in terms of survival without dysphagia in patients with inoperable stage II or III epidermoid carcinoma of the esophagus
Compare the overall survival response rate toxicity and quality of life in this patient population treated with these regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to weight loss less than 10 vs at least 10 and inoperability criteria nonresectable vs due to anatomical terrain Patients are randomized to one of two treatment arms
Arm I Patients receive fluorouracil IV continuously oral hydroxyurea and concurrent radiotherapy daily on days 1-5
Arm II Patients receive fluorouracil hydroxyurea and radiotherapy as in arm I Patients also receive paclitaxel IV on day 1
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with possible resectable disease undergo surgical resection at 4-6 weeks following the last course of chemoradiotherapy Patients with continued unresectable disease receive 2 additional courses of chemoradiotherapy as above within 8-17 days following the last course of chemoradiotherapy
Quality of life is assessed at baseline monthly during therapy every 2 months for 6 months every 4 months for 1 year and then every 6 months thereafter
Patients are followed every 2 months for 6 months every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 90 patients will be accrued for this study
Compare the efficacy of concurrent radiotherapy with fluorouracil and hydroxyurea with or without paclitaxel in terms of survival without dysphagia in patients with inoperable stage II or III epidermoid carcinoma of the esophagus
Compare the overall survival response rate toxicity and quality of life in this patient population treated with these regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to weight loss less than 10 vs at least 10 and inoperability criteria nonresectable vs due to anatomical terrain Patients are randomized to one of two treatment arms
Arm I Patients receive fluorouracil IV continuously oral hydroxyurea and concurrent radiotherapy daily on days 1-5
Arm II Patients receive fluorouracil hydroxyurea and radiotherapy as in arm I Patients also receive paclitaxel IV on day 1
Treatment continues every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients with possible resectable disease undergo surgical resection at 4-6 weeks following the last course of chemoradiotherapy Patients with continued unresectable disease receive 2 additional courses of chemoradiotherapy as above within 8-17 days following the last course of chemoradiotherapy
Quality of life is assessed at baseline monthly during therapy every 2 months for 6 months every 4 months for 1 year and then every 6 months thereafter
Patients are followed every 2 months for 6 months every 4 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 90 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20021 | None | None | None |
| FRE-GERCOR-D99-1 | None | None | None |