Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002631
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Cancer of the Esophagus
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III INTERGROUP RANDOMIZED COMPARISON OF COMBINED MODALITY THERAPY FOR CARCINOMA OF THE ESOPHAGUS HIGH-DOSE VS CONVENTIONAL-DOSE RADIATION THERAPY
Status:
COMPLETED
Status Verified Date:
2013-11
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 It is not known whether high-dose radiation therapy is more effective than standard dose radiation therapy in treating cancer of the esophagus
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy plus high- or standard-dose radiation therapy in treating patients with cancer of the esophagus
Detailed Description:
OBJECTIVES I Compare using a prospective controlled randomized study design the survival and failure patterns associated with conventional-dose radiotherapy and fluorouracilcisplatin 5-FUCDDP vs high-dose radiotherapy and 5-FUCDDP in patients with esophageal cancer II Compare the tolerance and quality of life of patients receiving these therapies
OUTLINE Randomized study Arm I Radiotherapy plus 2-Drug Combination ChemotherapyRadiosensitization Tumor irradiation using megavoltage photons of at least 6 MV electrons may be used if required to boost supraclavicular fossa dose plus Cisplatin CDDP NSC-119875 Fluorouracil 5-FU NSC-19893 High-dose radiotherapy Arm II Radiotherapy plus 2-Drug Combination ChemotherapyRadiosensitization Tumor irradiation as in Arm I plus CDDP5-FU Conventional-dose radiotherapy
PROJECTED ACCRUAL Up to 298 patients will be entered over 4 years
OUTLINE Randomized study Arm I Radiotherapy plus 2-Drug Combination ChemotherapyRadiosensitization Tumor irradiation using megavoltage photons of at least 6 MV electrons may be used if required to boost supraclavicular fossa dose plus Cisplatin CDDP NSC-119875 Fluorouracil 5-FU NSC-19893 High-dose radiotherapy Arm II Radiotherapy plus 2-Drug Combination ChemotherapyRadiosensitization Tumor irradiation as in Arm I plus CDDP5-FU Conventional-dose radiotherapy
PROJECTED ACCRUAL Up to 298 patients will be entered over 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064043 | None | None | None |
| E-R9405 | None | None | None |
| NCCTG-914051 | None | None | None |
| INT-0123 | None | None | None |