Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-05-08 @ 8:52 PM
Study NCT ID:
NCT00123318
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2005-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Study Overview
Official Title:
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The purpose of this study is to determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.
Detailed Description:
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques.
The specific objectives of the study are:
* To detail the acute toxicity associated with this treatment.
* To determine the feasibility of the proposed concurrent chemoradiation regimen.
* To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
The specific objectives of the study are:
* To detail the acute toxicity associated with this treatment.
* To determine the feasibility of the proposed concurrent chemoradiation regimen.
* To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
Study Oversight
Has Oversight DMC:
False
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?: