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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000525

Enrollment

Registered

2012-09-06

Start date

2012-09-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Radiation : 1. Radiotherapy - Radiotherapy must be started within 2 week from study enrollment - Patients have radiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 wo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
R0 resection rate	—

Secondary

Measure	Time frame
Overall survival rate;Progression free survival rate;Tumor regression grade(TRG);Toxicity	—

Countries

Korea, Republic of

Contacts

Public ContactWONIL JANG

Korea Institute of Radiological & Medical Sciences

Outcome results