drugset / Trial / NCT01792934
Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases
Active not recruiting
478 enrolled
Radboud University Medical Center
Erasmus Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2013-05
- Primary completion
- 2025-01
- Completion
- 2027-07
Publications
- Gootjes EC, Bakkerus L, Adhin AA, Zonderhuis BM, Versteeg KS, Tuynman JB, Meijerink MR, Haasbeek CJA, de Wilt JHW, Grunhagen DJ, Smit EJ, Primrose JM, Bridgewater J, van Meerten E, de Groot JB, Hendriks MP, Oomen-de Hoop E, Buffart TE, Verhoef C, Verheul HMW; ORCHESTRA Study Group. Tumor Debulking in Combination With Chemotherapy in Multiorgan Metastatic Colorectal Cancer: The ORCHESTRA Randomized Clinical Trial. JAMA. 2026 Apr 21;335(15):1311-1320. doi: 10.1001/jama.2026.1929.
- Bakkerus L, Buffart LM, Buffart TE, Meyer YM, Zonderhuis BM, Haasbeek CJA, Versteeg KS, Loosveld OJL, de Groot JWB, Hendriks MP, Verhoef C, Verheul HMW, Gootjes EC. Health-Related Quality of Life in Patients With Metastatic Colorectal Cancer Undergoing Systemic Therapy With or Without Maximal Tumor Debulking. J Natl Compr Canc Netw. 2023 Oct;21(10):1059-1066.e5. doi: 10.6004/jnccn.2023.7050.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |
| Subject | fluorouracil | Small molecule | — | — |