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.

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. - ORCHESTRA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54652

Enrollment

408

Registered

2012-03-05

Start date

2013-05-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

multi-orgaan gemetastaseerd colorectaal carcinoom multi-organ metastatic colorectal cancer

Interventions

After study inclusion, diagnostic biopsies or study biopsies will be obtained from a metastatic site. All patients will receive 3 cycles of capecitabine and oxaliplatin (XELOX) or comparable intrave

Eligibility

Age

18 Years to 99 Years

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

Exclusion criteria

Exclusion criteria: Prior (neo-)adjuvant chemotherapy for

Design outcomes

Primary

Measure	Time frame
The primary objective is overall survival counting from the date of study inclusion to the date of death.	—

Secondary

Measure	Time frame
Secondary objectives include: 1) Progression free survival (PFS), 2) To determine the safety and efficacy of the additional local treatment, 3) To determine quality of life in the two study arms, 4) To study whether CEA can predict for treatment response and survival, 5) To determine the relation of genomic (instability) profiles and response to therapy, 6) To study the relation of miRNA profiles and response to therapy, 7) To study (phospho)proteomic profiles in relation to response to therapy, 8) To study circulating endothelial cells (CECs) and cellular immunity in relation to response to therapy.	—

Measure

Time frame

Secondary objectives include: 1) Progression free survival (PFS), 2) To determine the safety and efficacy of the additional local treatment, 3) To determine quality of life in the two study arms, 4) To study whether CEA can predict for treatment response and survival, 5) To determine the relation of genomic (instability) profiles and response to therapy, 6) To study the relation of miRNA profiles and response to therapy, 7) To study (phospho)proteomic profiles in relation to response to therapy, 8) To study circulating endothelial cells (CECs) and cellular immunity in relation to response to therapy.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)