In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 4_suppl ( 2016-02-01), p. TPS788-TPS788
Abstract:
TPS788 Background: In the current multidisciplinary approach of mCRC, local treatment of oligometastases is common practice. Results of large case series of selected patients treated with complete surgical resection of metastatic lesions suggest that this approach substantially improves survival rates to around 30-60%. Other techniques such as radiofrequency or microwave ablation (RFA, MWA), transarterial chemoembolization (TACE) or radiotherapy can also be applied in local treatment. Curative treatment options are generally not available for patients with extensive hepatic and/or extrahepatic mCRC. These patients primarily receive palliative systemic treatment consisting of combination chemotherapy as well as targeted agents. So far, reports on the benefit of local treatment for metastases in multi-organ mCRC have major limitations, including being small, non-randomized, single-center and retrospective. The benefit from local treatment of metastases for these patients should be established to allow for interruption of the standard systemic therapy and exposure to possible adverse events from local treatment. Methods: The ‘ORCHESTRA’ trial is a randomized multicenter clinical trial for patients with multi-organ mCRC, comparing the combination of chemotherapy and maximal tumor debulking versuschemotherapy alone (NCT01792934). We will examine the interplay of both efficacy and toxicity for the combination of systemic chemotherapy and locoregional therapy. Our study design incorporates systemic as well as local therapy in the experimental arm and combines local treatment modalities to pursue maximal tumor debulking. We aim to improve overall survival of patients with multi-organ mCRC by maximal tumor debulking after induction chemotherapy with at least six months. A total of 478 patients will be included to meet the primary endpoint (power 80%, type I error rate 5%). We define local treatments feasible when they can be performed within a 3-month time period to prevent extensive delay of systemic therapy. Currently, 60 patients are included in 22 participating Dutch hospitals. Clinical trial information: NCT01792934.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2016.34.4_suppl.tps788
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2016
detail.hit.zdb_id:
2005181-5
detail.hit.zdb_id:
604914-X
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