Multicenter Phase II Study of Short Course Radiotherapy Followed by Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0000525
• Lead Sponsor: Korea Institute of Radiological & Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Pathologically confirmed adenocarcinoma of rectum
- Lower margin of tumor within 12 cm from anal verge
- Clinically locally advanced (T3-4 or N1-2) disease
- Potentially resectable and synchronous distant metastases in liver and/or lung
The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung funcion.
- Over 18 years
- ECOG 0-2
- Proper organ function (Hemoglobin = 10 g/dl, ANC = 1,500/mm3, Platent = 100,000/mm3, Creatinine = 1.5 mg/dl, Clearance of creatinine >50 ml/min using Cockcroft-Gault formula, Bilirubin = 1.5 x upper limit of normal (ULN), Liver enzyme (AST/ALT/ALP) = 2.5 x ULN)
- Subject who should sign on the informed consent form before participate the trial.

Exclusion Criteria

- Metastases in other organ except liver or lung
- History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
- Hereditary colorectal cancer (FAP, HNPCC, and etc)
- Bowel obstruction or impending bowel obstruction
- Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
- Subject pregnant or breast feeding, or incapable of appropriate contraception
- Unresected synchronous colorectal cancer
- History of prior pelvic radiotherapy
- History of prior chemotherapy for colorectal cancer
- Great surgery within 4 week before study enrollment
- Participant in other trial within 4 week before study enrollment

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 resection rate

Secondary Outcome Measures

Name	Time	Method
Overall survival rate;Progression free survival rate;Tumor regression grade(TRG);Toxicity