Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01271192
Status:
UNKNOWN
Last Update Posted:
2011-01-06
First Post:
2011-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Randomized Multicenter Clinical Trial of Direct Surgical Resection Compared to Neoadjuvant Followed by Surgical Resection in Treating Patients With Operable Local Recurrent Carcinoma Of The Rectum
Status:
UNKNOWN
Status Verified Date:
2010-12
Last Known Status:
RECRUITING
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:
NARC
Brief Summary:
RATIONALE: Surgical resection and adjuvant therapy has become the main treatment for resectable local recurrent rectal cancer. However the efficacy and safety of adjuvant therapy is still unknown.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.
PURPOSE: This randomized multicenter clinical trial is studying surgical resection followed by chemo radiotherapy or neoadjuvant chemo radiotherapy followed by surgery and postoperative chemotherapy, comparing them to see the efficacy and safety, then to investigate the effect of adjuvant chemoradiotherapy for resectable local recurrent rectal cancer.
Detailed Description:
OBJECTIVES:
Primary
\- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Secondary
* Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
* Compare the postoperative complications in patients treated with these regimens.
* Compare the recurrent rate in patients treated with these regimens.
* Compare the distant metastatic rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation.
* Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for at least 3 years.
The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate and 5-year survival rate will be investigated.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.
Primary
\- Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.
Secondary
* Compare the side effect of chemo radiotherapy according to the Common Toxicity Criteria(CTC) version 2.0 in patients treated with these regimens.
* Compare the postoperative complications in patients treated with these regimens.
* Compare the recurrent rate in patients treated with these regimens.
* Compare the distant metastatic rate in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter clinical trial. Patients are stratified according to participating center, gender, age. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive surgical resection and undergo FOLFIRI for 12 cycles, from 2-4 weeks after operation. Patients undergo radiotherapy once daily 5 days a week for 5-6 weeks, from 8-12 weeks after operation.
* Arm II: Patients receive neoadjuvant chemoradiotherapy (mFOLFIRI for 5 cycles and undergo radiotherapy as in arm I from the second cycle of FOLFIRI), surgery and FOLFORI for 7 cycles from 2-4 weeks after operation.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for at least 3 years.
The side effect of chemo radiotherapy, postoperative complications, recurrent rate, distant metastatic rate and 5-year survival rate will be investigated.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 5 year.
Study Oversight
Has Oversight DMC:
True
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?: