Evidence map›Paper›PMID 40130723›Full record

Trial reportCancer2025

A phase 2 study of adjuvant chemotherapy with 5-fluorouracil/leucovorin and oxaliplatin after lung metastasectomy for colorectal cancer (WJOG5810G).

Nozomu Machida, Takehiro Okumura, Narikazu Boku, Junji Kishimoto, Tomohiro Nishina, Koichi Suyama, Yasuhisa Ohde, Katsunori Shinozaki, Hideo Baba, Shinya Tokunaga and 9 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
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.

Nozomu MachidaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.ORCID https://orcid.org/0000-0001-9570-3670
Takehiro OkumuraDepartment of Surgery, University Hospital Mizonokuchi, Teikyo University School of Medicine, Kawasaki City, Kanagawa, Japan.ORCID https://orcid.org/0000-0002-2920-4926
Narikazu BokuDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki City, Kanagawa, Japan.ORCID https://orcid.org/0000-0002-1438-707X
Junji KishimotoCenter for Clinical and Translational Research, Kyushu University Hospital, Higashi-ku, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-3833-4052
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, NHO Shikoku Cancer Center, Matsuyama City, Ehime, Japan.ORCID https://orcid.org/0000-0002-4073-3757
Koichi SuyamaDepartment of Medical Oncology, Toranomon Hospital, Minato-ku, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1788-1911
Yasuhisa OhdeDivision of Thoracic Surgery, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.ORCID https://orcid.org/0000-0002-1664-2628
Katsunori ShinozakiDivision of Clinical Oncology, Hiroshima Prefectural Hospital, Minami-ku, Hiroshima, Japan.ORCID https://orcid.org/0000-0003-0596-3423
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Chuo-ku, Kumamoto, Japan.ORCID https://orcid.org/0000-0002-3474-2550
Shinya TokunagaDepartment of Medical Oncology, Osaka City General Hospital, Miyakojima-ku, Osaka, Japan.
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama City, Osaka, Japan.ORCID https://orcid.org/0000-0002-3280-4850
Takashi TsudaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki City, Kanagawa, Japan.ORCID https://orcid.org/0000-0001-7396-7675
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe City, Hyogo, Japan.ORCID https://orcid.org/0000-0001-5976-613X
Hiroyuki OkudaDepartment of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo City, Hokkaido, Japan.ORCID https://orcid.org/0000-0001-8452-6189
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe City, Hyogo, Japan.ORCID https://orcid.org/0000-0001-5563-5802
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan.ORCID https://orcid.org/0000-0001-6269-9345
Shuichi HironakaClinical Trial Promotion Department, Chiba Cancer Center, Chuo-ku, Chiba, Japan.ORCID https://orcid.org/0000-0001-9714-231X
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya City, Aichi, Japan.ORCID https://orcid.org/0000-0002-5572-743X
Ichinosuke HyodoDivision of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba City, Ibaraki, Japan.ORCID https://orcid.org/0000-0001-8210-0731

Funding

West Japan Oncology Group
6 · The paper itself

Abstract

backgroundThe clinical significance of adjuvant chemotherapy after lung metastasectomy for colorectal cancer remains unknown. This phase 2 study evaluated adjuvant chemotherapy with modified 5-fluorouracil/leucovorin and oxaliplatin (mFOLFOX6) after lung metastasectomy.

methodsEligibility criteria included colorectal adenocarcinoma, first curative resection of ≤4 lung metastases, and no prior chemotherapy. Treatment consisted of 12 cycles of mFOLFOX6. The primary endpoint was the 5-year overall survival (OS) rate, with the expectation of 50% (threshold, 35%) and a planned sample size of 100 (90% power; alpha error, 5%).

resultsFifty-two patients were enrolled between July 2011 and July 2014; patient enrollment was closed prematurely because of slow accrual. Excluding four ineligible patients, the characteristics of the 48 patients in the efficacy analysis set were a median age of 62 years (range, 43-75 years), Eastern Cooperative Oncology Group performance status of 0 in 45 patients, prior resection of extrathoracic metastasis in four patients, and postoperative carcinoembryonic antigen within normal range in 43 patients; the status of lung metastasis was single in 34 patients, unilateral in 40 patients, and metachronous in 41 patients; and a disease-free interval between primary tumor resection and diagnosis of lung metastasis of <2 years in 33 patients. The 5-year OS rate was 85.2% (95% confidence interval [CI], 71.4%-92.6%), and the 5-year disease-free survival rate was 60.2% (95% CI, 44.9%-72.4%). Forty-one of the 52 patients (78.8%) in the safety analysis set completed 12 cycles of mFOLFOX6. Grade ≥3 adverse events were neutropenia (50.0%), fatigue (7.7%), peripheral sensory neuropathy (7.7%), and other (<5%).

conclusionsAdjuvant chemotherapy with mFOLFOX6 is feasible, and may be effective after lung metastasectomy for colorectal cancer.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsLung NeoplasmsAdultAgedChemotherapy, AdjuvantFemaleFluorouracilHumansLeucovorinMaleMetastasectomyMiddle AgedOrganoplatinum CompoundsOxaliplatinFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatinadjuvant chemotherapycolorectal cancerlung metastasectomymodified 5‐fluorouracil/leucovorin and oxaliplatin (mFOLFOX6)oligometastasis

Identifiers

PMID40130723
PMCPMC11934843

What OpenQuestion holds

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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.