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Irinotecan

Fluorouracil

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

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.

Postoperative:

Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

surgical resection and adjuvant therapy

Preoperative:

Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks

Postoperative:

Drug: fluorouracil Given IV continuously,Irinotecan Given IV

Neoadjuvant followed by operation

Ping Lan, M.D.

Pang Lan, M.D.

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.

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.

Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer

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

Compare the 5-year survival rate in patients with resectable local recurrent rectal cancer treated with either surgical resection or neoadjuvant.

* Compare the postoperative complications in patients treated with these regimens
* Compare the recurrent rate in these patients
* Compare the distant metastatic rate in these patients
* Compare preoperative quality of life (QOL) of patients.
* Compare the toxic effects of these regimens in these patients.
* Compare the convenience of care in patients treated with these regimens

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer	NCT01271192	Rectal Cancer	surgical resect... Neoadjuvant fol...	18 Years - 80 Years	Sun Yat-sen University
Efficacy and Safety Study of Neoadjuvant in Treating Patients With Resectable Local Recurrent Rectal Cancer	NCT01271192	Rectal Cancer	surgical resect... Neoadjuvant fol...	18 Years - 80 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for surgical resection and adjuvant therapy