Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069953
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2003-10-03
Brief Title:
Combination Chemotherapy Followed By Chemoradiotherapy With or Without Surgery in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as paclitaxel fluorouracil and cisplatin 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
PURPOSE This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy with or without surgery works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction
PURPOSE This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy with or without surgery works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction
Detailed Description:
OBJECTIVES
Determine the feasibility of treatment with paclitaxel cisplatin and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction
Determine the overall and disease-free survival of patients treated with this regimen
Determine the treatment-related toxicity of this regimen in these patients
Determine the tolerance to surgical salvage in patients treated with this regimen
Determine the morbidity and mortality of surgical salvage in patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive fluorouracil 5-FU IV continuously over 96 hours beginning on days 1 and 29 cisplatin IV over 1 hour on days 1-5 and 29-33 paclitaxel IV over 2 hours on days 1 and 29 and pegfilgrastim subcutaneously SC on days 6 and 34 OR filgrastim G-CSF SC on days 6-15 and 34-42 Treatment continues in the absence of unacceptable toxicity
Chemoradiotherapy Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61 64-68 71-75 78-82 85-89 and 92-96 Patients concurrently undergo external beam radiotherapy on days 57-61 64-68 71-75 78-82 85-89 and 92-96
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy
Patients are followed periodically
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study within 18 months
Determine the feasibility of treatment with paclitaxel cisplatin and fluorouracil followed by chemoradiotherapy and possible surgical salvage in patients with resectable locally advanced carcinoma of the esophagus or gastroesophageal junction
Determine the overall and disease-free survival of patients treated with this regimen
Determine the treatment-related toxicity of this regimen in these patients
Determine the tolerance to surgical salvage in patients treated with this regimen
Determine the morbidity and mortality of surgical salvage in patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive fluorouracil 5-FU IV continuously over 96 hours beginning on days 1 and 29 cisplatin IV over 1 hour on days 1-5 and 29-33 paclitaxel IV over 2 hours on days 1 and 29 and pegfilgrastim subcutaneously SC on days 6 and 34 OR filgrastim G-CSF SC on days 6-15 and 34-42 Treatment continues in the absence of unacceptable toxicity
Chemoradiotherapy Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV continuously on days 57-61 64-68 71-75 78-82 85-89 and 92-96 Patients concurrently undergo external beam radiotherapy on days 57-61 64-68 71-75 78-82 85-89 and 92-96
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy
Patients are followed periodically
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| CDR0000306455 | None | None | None |