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

NCT01643070 | Completed Phase 2 Results DMC

• 1 other identifier: XELOX-RT
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Liver Metastases

Keywords

Rectal cancer; Liver metastases; Capecitabine; Oxaliplatin

Outcome Measures

Primary Outcomes (3)

• Quality of Surgery for Primary Tumor

  R0 = complete resection with grossly and microscopically negative margins of resection; R1 =grossly negative but microscopically positive margins of resection; R2 = grossly and microscopically positive margins of resection

  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 = complete resection with grossly and microscopically negative margins of resection; R1 =grossly negative but microscopically positive margins of resection; R2 = grossly and microscopically positive margins of resection

  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)

• R0 Resection Rate of Both the Primary Tumor and Livermetastases

  synchronous complete R0 resection rate, R0 = complete resection with grossly and microscopically negative margins of resection

  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)

Secondary Outcomes (2)

• Pathologic Complete Response Rate of Primary Tumor

  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)

• Tumor Regression Grade (Primary Tumor)

  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)

Study Arms (2)

XELOX RT

ACTIVE COMPARATOR

Concurrent XELOX-RT (Capecitabine, Oxaliplatin, radiotherapy)

Drug: Capecitabine, Oxaliplatin; Radiation: Radiotherapy

Induction XELOX

ACTIVE COMPARATOR

Induction XELOX(Capecitabine, Oxaliplatin) followed by XELOX-RT (Capecitabine, Oxaliplatin, radiotherapy)

Drug: Capecitabine, Oxaliplatin; Radiation: Radiotherapy

Interventions

Capecitabine, Oxaliplatin DRUG

Induction chemotherapy - Induction XELOX (Capecitabine 1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - XELOX RT (Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.)

Induction XELOX; XELOX RT

Radiotherapy RADIATION

Preoperative radiotherapy, 5040 cGy with 28 fractions

Induction XELOX; XELOX RT

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Unresectable liver metastases (6 or more metastatic lesions, major vessel invasion)
• Extrahepatic metastasis

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa, 138736, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOX; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Tae Won Kim
• Organization: Asan Medical Center

twkimmd@amc.seoul.kr

+82-2-3010-3910

Study Officials

• Tae Won Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: July 17, 2012
• Study Start: January 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Locations

KR (1)