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Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases

NCT01792934 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2025-04-15

No results posted yet for this study

Summary

The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and SBRT, depending on best clinical judgement according to a standardized treatment algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment with chemotherapy and biologicals will provide an improvement in progression free and overall survival in this patient group.

Conditions

  • Multi-organ Metastatic Colorectal Cancer

Interventions

DRUG

XELOX regimen according to standard procedures

DRUG

FOLFOX regimen according to standard procedures

PROCEDURE

Surgery

OTHER

radiofrequency ablation (RFA)

OTHER

transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE)

RADIATION

stereotactic body radiation therapy (SBRT)

DRUG

Bevacizumab

may be added to both regimens according to standard procedures

PROCEDURE

tumor biopsy

at baseline (diagnostic or study) biopsy and after 3 or 4 cycles an optional tumor biopsy

Sponsors & Collaborators

Principal Investigators

  • H.M.W. Verheul, MD PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2025-01-31
Completion
2027-07-31

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792934 on ClinicalTrials.gov