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

  • participants needed
  • sponsor
    Sun Yat-sen University
Updated on 8 November 2020
adenocarcinoma of rectum


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.




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


  • 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.

Condition Rectal Cancer
Treatment surgical resection and adjuvant therapy, Neoadjuvant followed by operation
Clinical Study IdentifierNCT01271192
SponsorSun Yat-sen University
Last Modified on8 November 2020


Yes No Not Sure

Inclusion Criteria

Diagnosis of Adenocarcinoma of the rectum
Age:18-80 years old
Received curative resection when diagnosed as rectal cancer
Local recurrence happened >6 months after operation,without distant metastasis
Local recurrent mass is resectable confirmed by surgeon and radiologist 6.15 days prior recruit, meet the following criteria
Absolute neutrophil count 1,500/mm^3
Platelet count 100,000/mm^3
Total bilirubin 1.5 times upper limit of normal (ULN)
Alkaline phosphatase 2 times ULN
AST 2.5 times ULN
ALT 2.5 times ULN
No hepatic disease that would preclude study treatment or follow-up
No uncontrolled coagulopathy
Creatinine clearance > 50 mL/min
No renal disease that would preclude study treatment or follow-up
ECOG status: 01

Exclusion Criteria

Other rectal cancers (i.e.sarcoma,lymphoma,carcinoid,squamous cell carcinoma,or cloacogenic carcinoma)
Synchronous colon cancer
Hypersensitivity to fluorouracil
No More than 4 weeks since prior participation in any investigational drug study
Clear indication of involvement of the pelvic side walls by imaging With distant metastasis
History of invasive rectal malignancy, regardless of disease-free interval Fertile patients must use effective contraception
Uncontrolled hypertension
Cardiovascular disease that would preclude study treatment or follow-up
Lack of upper gastrointestinal tract integrity or malabsorption syndromeactive upper gastrointestinal tract bleeding
Pregnant or nursing, Fertile patients do not use effective contraception
Other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum
No psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation
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