Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145769
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2005-09-02
Brief Title:
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This is a multi-centre randomised trial comparing long course LC preoperative chemoradiation with short course SC preoperative radiotherapy for patients with localised T3 rectal cancer
Detailed Description:
Objective
The objective is in patients with T3 clinically resectable carcinoma of the rectum to demonstrate that the local recurrence rate in patients treated with a long course LC of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course SC of pre-operative radiotherapy with early surgery
Eligibility Criteria
The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge and no evidence of distant metastases
Endpoints
Primary endpoint is local recurrence
Secondary endpoints are overall survival toxicity abdminoperineal resection rate quality of life
Treatment arms
SC arm Radiotherapy RT 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FUFolinic acid
LC arm RT 504 Gy in 28 fr in 5½weeks with 5FU 225 mgm2day throughout the course of RT to be followed by surgery 4-6 weeks after completion of RT 4 cycles of adjuvant 5FUFolinic acid will be given
The objective is in patients with T3 clinically resectable carcinoma of the rectum to demonstrate that the local recurrence rate in patients treated with a long course LC of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course SC of pre-operative radiotherapy with early surgery
Eligibility Criteria
The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge and no evidence of distant metastases
Endpoints
Primary endpoint is local recurrence
Secondary endpoints are overall survival toxicity abdminoperineal resection rate quality of life
Treatment arms
SC arm Radiotherapy RT 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FUFolinic acid
LC arm RT 504 Gy in 28 fr in 5½weeks with 5FU 225 mgm2day throughout the course of RT to be followed by surgery 4-6 weeks after completion of RT 4 cycles of adjuvant 5FUFolinic acid will be given
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 |
|---|---|---|---|
| NHMRC 209123 | OTHER_GRANT | National Health Medical and Research Council | None |