A study comparing the effect of chemotherapy with the effect of chemotherapy plus local removal of metastases for patients with cancer of the large bowel which has spread to multiple organs.

A randomized multicenter clinical trial for patients with multi-organ, colorectal cancer metastases comparing the combination of chemotherapy and maximal tumor debulking versus chemotherapy alone.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005003-32-NL

Enrollment

478

Registered

2012-03-05

Start date

2012-06-14

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

multi-organ metastatic colorectal cancer MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Xeloda Product Name: capecitabin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: CAPECITABINE CAS Number: 154361-50-9 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with indication for first line palliative systemic treatment for metatastatic colorectal cancer, with CRC metastases in = 2 different organs, minimum age 18 years, life expectancy of at least 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 239 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 239

Exclusion criteria

Exclusion criteria: Prior (neo-)adjuvant chemotherapy < 6 months after last treatment and first detection of metastasis (except for neoadjuvant capecitabin in the context of chemoradiation for rectal carcinoma), candidates for HIPEC, evidence of brain metastases, history of cardiac disease, uncontrolled hypertension, uncontrolled infections, pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to compare overall survival rates of CRC patients with multi-organ metastases with indication for first line palliative systemic treatment for mCRC, 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 judgment according to a standardized treatment algorithm.;Secondary Objective: Progression free survival, counting from the date of study inclusion to the date of either progressive or recurrent disease. To determine safety and efficacy of additional local treatment in combination with chemotherapy . To determine quality of life in the two study arms. To study whether carcinoembryonic antigen (CEA) can predict for treatment response and progression free survival. ;Primary end point(s): Overall survival rates in both study arms. ;Timepoint(s) of evaluation of this end point: OS will be defined counting from the date of study inclusion to the date of death due to CRC or to the last day of follow-up. Follow-up information will be obtained in up to a mandated 3 years follow-up regimen.	—

Measure

Time frame

Main Objective: The main objective of this study is to compare overall survival rates of CRC patients with multi-organ metastases with indication for first line palliative systemic treatment for mCRC, 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 judgment according to a standardized treatment algorithm.;Secondary Objective: Progression free survival, counting from the date of study inclusion to the date of either progressive or recurrent disease. To determine safety and efficacy of additional local treatment in combination with chemotherapy . To determine quality of life in the two study arms. To study whether carcinoembryonic antigen (CEA) can predict for treatment response and progression free survival. ;Primary end point(s): Overall survival rates in both study arms. ;Timepoint(s) of evaluation of this end point: OS will be defined counting from the date of study inclusion to the date of death due to CRC or to the last day of follow-up. Follow-up information will be obtained in up to a mandated 3 years follow-up regimen.

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Secondary

Measure	Time frame
Secondary end point(s): - Progression free survival rates (PFS) - response rates - safety and efficacy of additional local treatment - quality of life;Timepoint(s) of evaluation of this end point: - PFS will be defined counting from the date of study inclusion to the first event defined as local recurrence or progression, distant recurrence or death from any cause. - response rates will be assessed after 6 weeks. In study arm A again after 4 or 5 cycles, then continuing with every 3 or 4 cycles. In study arm B after additional 3 or 4 cycles, after completing local treatment response will be evaluated every 3 months until progression. After 3 years of follow-up evaluation will be performed every 6 months. - after inclusion of 25,50 and 100 patients; when 30% of the total number of patients is included in the study for 12 months and at end of study. - QoL: every 3 months	—

Measure

Time frame

Secondary end point(s): - Progression free survival rates (PFS) - response rates - safety and efficacy of additional local treatment - quality of life;Timepoint(s) of evaluation of this end point: - PFS will be defined counting from the date of study inclusion to the first event defined as local recurrence or progression, distant recurrence or death from any cause. - response rates will be assessed after 6 weeks. In study arm A again after 4 or 5 cycles, then continuing with every 3 or 4 cycles. In study arm B after additional 3 or 4 cycles, after completing local treatment response will be evaluated every 3 months until progression. After 3 years of follow-up evaluation will be performed every 6 months. - after inclusion of 25,50 and 100 patients; when 30% of the total number of patients is included in the study for 12 months and at end of study. - QoL: every 3 months

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Countries

Netherlands, United States

Contacts

Public ContactDepartment of Medical Oncology

VU University Medical Center

h.verheul@vumc.nl00310204444321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026