CompletedPhase 2

Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases

South Korea38 participantsStarted 2010-01

Plain-language summary

To investigate the feasibility of preoperative chemoradiation with oxaliplatin plus capecitabine, with or without prior induction chemotherapy in patients with locally advanced or marginally resectable rectal cancer with resectable synchronous liver metastases.

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum Tumor located within 12 cm from anal verge Clinical stage of T3-4 or N+ by rectal MRI ± endorectal ultrasound Age over 18 years No prior systemic treatment or radiation Adequate major organ functions Borderline resectability of primary rectal cancer Complete resectability of liver metastases (measurable by RECIST 1.1) Exclusion Criteria: * Unresectable liver metastases (6 or more metastatic lesions, major vessel invasion) * Extrahepatic metastasis

What they're measuring

Quality of Surgery for Primary Tumor

Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)

Quality of Surgery for Liver Metastases

R0 Resection Rate of Both the Primary Tumor and Livermetastases

Trial details

NCT IDNCT01643070

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2021-02-14

View on ClinicalTrials.gov More Rectal Cancer trials