Evidence map›Paper›PMID 32490570›Full record

Trial reportThe oncologist2020

Safety and Feasibility of Additional Tumor Debulking to First-Line Palliative Combination Chemotherapy for Patients with Multiorgan Metastatic Colorectal Cancer.

Elske C Gootjes, Eric P van der Stok, Tineke E Buffart, Lotte Bakkerus, Mariette Labots, Barbara M Zonderhuis, Jurriaan B Tuynman, Martijn R Meijerink, Peter M van de Ven, Cornelis J A Haasbeek and 9 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01792934 (A Randomized Multicenter Clinical Trial for Patient With Multi-organ, Colorectal Cancer Metastases Comparing the Combination of Chemotherapy and Maximal Tumor Debulking Versus Chemotherapy Alone.), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01792934 naactive not recruitingnot on this map

A Randomized Multicenter Clinical Trial for Patient With Multi-organ, Colorectal Cancer Metastases Comparing the Combination of Chemotherapy and Maximal Tumor Debulking Versus Chemotherapy Alone.

TypeinterventionalSponsorRadboud University Medical CenterRan2013 to 2028Enrolled478ConditionsMulti-organ Metastatic Colorectal CancerArmsXELOX regimen according to standard procedures, FOLFOX regimen according to standard procedures, Surgery, radiofrequency ablation (RFA), transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 2 countries.

Elske C Gootjes *Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Eric P van der Stok *Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Tineke E BuffartDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Lotte BakkerusDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Mariette LabotsDepartment of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.
Barbara M ZonderhuisDepartment of Surgery, VU University Medical Center, Amsterdam, The Netherlands.
Jurriaan B TuynmanDepartment of Surgery, VU University Medical Center, Amsterdam, The Netherlands.
Martijn R MeijerinkDepartment of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
Peter M van de VenDepartment of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
Cornelis J A HaasbeekDepartment of Radiotherapy, VU University Medical Center, Amsterdam, The Netherlands.
Albert J Ten TijeDepartment of Medical Oncology, Amphia Hospital, Breda, The Netherlands.
Jan-Willem B de GrootDepartment of Medical Oncology, Isala, The Netherlands.
Mathijs P HendriksDepartment of Medical Oncology, Northwest Clinics, Alkmaar, The Netherlands.
Esther van MeertenDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Joost J M E NuyttensDepartment of Radiotherapy, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Dirk J GrunhagenDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Cornelis Verhoef *Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Henk M W Verheul *Department of Medical Oncology, VU University Medical Center, Amsterdam, The Netherlands.ORCID 0000-0001-5981-922X
ORCHESTRA study group
Amsterdam UMC Location VUmc · NLErasmus MC Cancer Institute · NLAmphia Ziekenhuis · NLIsala · NLNorthwest Hospital · USRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLocal treatment of metastases is frequently performed in patients with multiorgan metastatic colorectal carcinoma (mCRC) analogous to selected patients with oligometastatic disease for whom this is standard of care. The ORCHESTRA trial (NCT01792934) was designed to prospectively evaluate overall survival benefit from tumor debulking in addition to chemotherapy in patients with multiorgan mCRC. Here, we report the preplanned safety and feasibility evaluation after inclusion of the first 100 patients.

methodsPatients were eligible if at least 80% tumor debulking was deemed feasible by resection, radiotherapy and/or thermal ablative therapy. In case of clinical benefit after three or four cycles of respectively 5-fluorouracil/leucovorin or capecitabine and oxaliplatin ± bevacizumab patients were randomized to tumor debulking followed by chemotherapy in the intervention arm, or standard treatment with chemotherapy.

resultsTwelve patients dropped out prior to randomization for various reasons. Eighty-eight patients were randomized to the standard (n = 43) or intervention arm (n = 45). No patients withdrew after randomization. Debulking was performed in 82% (n = 37). Two patients had no lesions left to treat, five had progressive disease, and one patient died prior to local treatment. In 15 patients (40%) 21 serious adverse events related to debulking were reported. Postoperative mortality was 2.7% (n = 1). After debulking chemotherapy was resumed in 89% of patients.

conclusionTumor debulking is feasible and does not prohibit administration of palliative chemotherapy in the majority of patients with multiorgan mCRC, despite the occurrence of serious adverse events related to local treatment. IMPLICATIONS FOR PRACTICE: This first prospective randomized trial on tumor debulking in addition to chemotherapy shows that local treatment of metastases is feasible in patients with multiorgan metastatic colorectal cancer and does not prohibit administration of palliative systemic therapy, despite the occurrence of serious adverse events related to local treatment. The trial continues accrual, and overall survival (OS) data and quality of life assessment are collected to determine whether the primary aim of >6 months OS benefit with preserved quality of life will be met. This will support evidence-based decision making in multidisciplinary colorectal cancer care and can be readily implemented in daily practice.

Indexed as

Colorectal NeoplasmsCytoreduction Surgical ProceduresAntineoplastic Combined Chemotherapy ProtocolsBevacizumabFeasibility StudiesFluorouracilHumansLeucovorinProspective StudiesQuality of LifeBevacizumabFluorouracilLeucovorinCytoreductionDebulkingMetastatic colorectal cancerRadiofrequency ablationStereotactic ablative radiotherapy

Identifiers

PMID32490570
PMCPMC7418352
OpenAlexW3032123541

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.