Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009880
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2001-02-02
Brief Title:
Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Non-Operative Therapy Of Local-Regional Carcinoma Of The Esophagus A Randomizd Phase II Study Of Two Paclitaxel-Based Chemoradiotherapy Regimens
Status:
COMPLETED
Status Verified Date:
2004-07
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 and radiation therapy may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach
Detailed Description:
OBJECTIVES
Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin paclitaxel and concurrent radiotherapy with or without fluorouracil
Compare the tolerance of these regimens by these patients
Compare the overall quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to percentage of weight loss less than 10 vs 10 or more disease histology adenocarcinoma vs squamous cell carcinoma and lesion size no more than 5 cm vs more than 5 cm Patients are randomized to one of two treatment arms
Arm I Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5 paclitaxel IV continuously over 24 hours on day 1 and filgrastim G-CSF subcutaneously daily on days 6-15 Treatment repeats every 4 weeks for up to 2 courses Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy Patients with local disease progression after the first course proceed to chemoradiotherapy
Beginning on day 29 of the last course of induction chemotherapy patients undergo radiotherapy 5 days a week for 55 weeks Patients also receive fluorouracil IV continuously over 24 hours on days 1-5 8-12 15-19 22-26 and 29-33 and paclitaxel IV over 3 hours on days 1 8 15 22 and 29
Arm II Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1 Treatment continues every 3 weeks for 2 courses as in arm I
Beginning on day 29 of the last course of induction chemotherapy patients undergo radiotherapy as in arm I Patients also receive cisplatin IV on days 1 8 15 22 29 and 36 and paclitaxel IV continuously over 96 hours on days 1-4 8-11 15-18 22-25 29-32 and 36-39
Quality of life is assessed at baseline within 1 week after radiotherapy at 6 weeks after study completion every 4 months for 1 year every 6 months for 2 years and then annually for 5 years
Patients are followed within 8 weeks every 4 months for 1 year every 6 months for two years and then annually thereafter
PROJECTED ACCRUAL A total of 84 patients 42 per treatment arm will be accrued for this study within 21 months
Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin paclitaxel and concurrent radiotherapy with or without fluorouracil
Compare the tolerance of these regimens by these patients
Compare the overall quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to percentage of weight loss less than 10 vs 10 or more disease histology adenocarcinoma vs squamous cell carcinoma and lesion size no more than 5 cm vs more than 5 cm Patients are randomized to one of two treatment arms
Arm I Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5 paclitaxel IV continuously over 24 hours on day 1 and filgrastim G-CSF subcutaneously daily on days 6-15 Treatment repeats every 4 weeks for up to 2 courses Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy Patients with local disease progression after the first course proceed to chemoradiotherapy
Beginning on day 29 of the last course of induction chemotherapy patients undergo radiotherapy 5 days a week for 55 weeks Patients also receive fluorouracil IV continuously over 24 hours on days 1-5 8-12 15-19 22-26 and 29-33 and paclitaxel IV over 3 hours on days 1 8 15 22 and 29
Arm II Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1 Treatment continues every 3 weeks for 2 courses as in arm I
Beginning on day 29 of the last course of induction chemotherapy patients undergo radiotherapy as in arm I Patients also receive cisplatin IV on days 1 8 15 22 29 and 36 and paclitaxel IV continuously over 96 hours on days 1-4 8-11 15-18 22-25 29-32 and 36-39
Quality of life is assessed at baseline within 1 week after radiotherapy at 6 weeks after study completion every 4 months for 1 year every 6 months for 2 years and then annually for 5 years
Patients are followed within 8 weeks every 4 months for 1 year every 6 months for two years and then annually thereafter
PROJECTED ACCRUAL A total of 84 patients 42 per treatment arm will be accrued for this study within 21 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068420 | None | None | None |