Evidence map›Paper›PMID 33560877›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Primary Tumor Resection Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastases (JCOG1007; iPACS): A Randomized Clinical Trial.

Yukihide Kanemitsu, Kohei Shitara, Junki Mizusawa, Tetsuya Hamaguchi, Dai Shida, Koji Komori, Satoshi Ikeda, Hitoshi Ojima, Hideyuki Ike, Akio Shiomi and 11 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 101 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 3 pooled it
14.5field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 3 syntheses or guidelines pooled it, 191 citations in OpenAlex.

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  20. Frontiers in pharmacology · 2026
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41 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 1 country.

Yukihide KanemitsuNational Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-3366-3826
Kohei ShitaraNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-5196-3630
Junki MizusawaNational Cancer Center Hospital, Tokyo, Japan.
Tetsuya HamaguchiSaitama Medical University International Medical Center, Hidaka, Japan.
Dai ShidaNational Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-3294-1924
Koji KomoriAichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-6834-995X
Satoshi IkedaHiroshima Prefectural Hospital, Hiroshima, Japan.
Hitoshi OjimaGunma Prefectural Cancer Center, Ota, Japan.
Hideyuki IkeSaiseikai Yokohamashi Nanbu Hospital, Yokohama, Japan.
Akio ShiomiShizuoka Cancer Center Hospital, Shizuoka, Japan.
Jun WatanabeYokohama City University Medical Center, Yokohama, Japan.ORCID 0000-0002-7187-3664
Yasumasa TakiiNiigata Cancer Center Hospital, Niigata, Japan.ORCID 0000-0001-9712-8542
Takashi YamaguchiNational Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Kenji KatsumataTokyo Medical University, Tokyo, Japan.
Masaaki ItoNational Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-1101-2707
Junji OkudaOsaka Medical College Hospital, Osaka, Japan.
Ryoji HyakudomiShimane University Faculty of Medicine, Shimane, Japan.
Yasuhiro ShimadaKochi Health Sciences Center, Kochi, Japan.
Hiroshi KatayamaNational Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaNational Cancer Center Hospital, Tokyo, Japan.
JCOG Colorectal Cancer Study Group
Tokyo National Hospital · JPNational Cancer Center Hospital East · JPAichi Cancer Center · JPHiroshima Prefectural Hospital · JPHyogo Prefectural Cancer Center · JPKyoto Medical Center · JPNiigata Cancer Center Hospital · JPOsaka Medical and Pharmaceutical University · JPSaiseikai Ibaraki Hospital · JPSaitama Medical University · JPShimane University · JPShizuoka Cancer Center · JPTokyo Medical University · JPUniversity of Kochi · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIt remains controversial whether primary tumor resection (PTR) before chemotherapy improves survival in patients with colorectal cancer (CRC) with asymptomatic primary tumor and synchronous unresectable metastases. PATIENTS AND

methodsThis randomized phase III study investigated the superiority of PTR followed by chemotherapy versus chemotherapy alone in relation to overall survival (OS) in patients with unresectable stage IV asymptomatic CRC and three or fewer unresectable metastatic diseases confined to the liver, lungs, distant lymph nodes, or peritoneum. Chemotherapy regimens of either mFOLFOX6 plus bevacizumab or CapeOX plus bevacizumab were decided before study entry. The primary end point was OS, which was analyzed by intention-to-treat.

resultsBetween June 2012 and September 2019, a total of 165 patients were randomly assigned to either chemotherapy alone (84 patients) or PTR plus chemotherapy (81 patients). When the first interim analysis was performed in September 2019 with 50% (114/227) of the expected events observed among 160 patients at the data cutoff date of June 5, 2019, the Data and Safety Monitoring Committee recommended early termination of the trial because of futility. With a median follow-up of 22.0 months, median OS was 25.9 months (95% CI, 19.9 to 31.5) in the PTR plus chemotherapy arm and 26.7 (95% CI, 21.9 to 32.5) in the chemotherapy-alone arm (hazard ratio, 1.10; 95% CI, 0.76 to 1.59; one-sided

conclusionGiven that PTR followed by chemotherapy showed no survival benefit over chemotherapy alone, PTR should no longer be considered a standard of care for patients with CRC with asymptomatic primary tumors and synchronous unresectable metastases.

Indexed as

AgedAnemiaAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsCombined Modality TherapyFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingOutcome Assessment, Health CareBevacizumab

Identifiers

PMID33560877
PMCPMC8078424
OpenAlexW3128475185

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.