Evidence map›Paper›PMID 36581973›Full record

ArticleBMJ open2022

Multicentre single-arm phase II trial evaluating the safety and effiCacy of Panitumumab and iRinOtecan in NeoRAS Wild-type mEtaStatic colorectal cancer patientS (C-PROWESS trial): study protocol.

Hiroki Osumi, Naoki Ishizuka, Atsuo Takashima, Yosuke Kumekawa, Daisuke Nakano, Manabu Shiozawa, Tadamichi Denda, Ryoichi Sawada, Kota Ouchi, Takeru Wakatsuki and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.4field-weighted citation impact, top 17% 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

15 citing papers in PubMed, 14 citations in OpenAlex.

  1. Kinetic Profiling ofJCO precision oncology · 2024
    Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Current Status of Precision Medicine in Colorectal Cancer in Japan.International journal of molecular sciences · 2025
    Review
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Anti-epidermal growth factor receptor treatment for patients with NeoTherapeutic advances in medical oncology · 2023
    Article
  14. Article
  15. Review
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

14 authors at 9 institutions in 1 country.

Hiroki OsumiDepartment of Gastroenterology, Cancer Institute Hospital Gastroenterology Center, Koto-ku, Tokyo, Japan.ORCID 0000-0002-4742-0446
Naoki IshizukaDepartment of Clinical Trial Planning and Management, Cancer Institute Hospital Gastroenterology Center, Koto-ku, Tokyo, Japan.
Atsuo TakashimaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Yosuke KumekawaDivison of Gastrointestinal Oncology, Saitama Cancer Center, Saitama, Japan.
Daisuke NakanoDepartment of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Manabu ShiozawaDepartment of Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Ryoichi SawadaDivision of Gastroenterology and Hepatology, Jikei University Hospital, Tokyo, Japan.
Kota OuchiDepartment of Medical Oncology, Tohoku University Hospital, Miyagi, Japan.
Takeru WakatsukiDepartment of Gastroenterology, Cancer Institute Hospital Gastroenterology Center, Koto-ku, Tokyo, Japan.
Boku NarikazuDepartment of Medical Oncology and General Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
Kensei YamaguchiDepartment of Gastroenterology, Cancer Institute Hospital Gastroenterology Center, Koto-ku, Tokyo, Japan.
Eiji ShinozakiDepartment of Gastroenterology, Cancer Institute Hospital Gastroenterology Center, Koto-ku, Tokyo, Japan eiji.shinozaki@jfcr.or.jp.
The Cancer Institute Hospital · JPNational Cancer Center Hospital East · JPChiba Cancer Center · JPKanagawa Prefectural Hospital Organization · JPSaitama Cancer Center · JPThe Jikei University Hospital · JPTohoku University Hospital · JPTokyo Medical University · JPTokyo Metropolitan Komagome Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA new concept of 'NeoRAS wild-type (WT)', which means conversion of RAS status from RAS mutant to RAS WT after treatment, has been reported. Previous observational and proof-of-concept studies have demonstrated the efficacy of epidermal growth factor receptor inhibitors in patients with NeoRAS WT metastatic colorectal cancer (mCRC). Moreover, posthoc biomarker analyses of these studies have suggested that not only the RAS status in the circulating tumour DNA (ctDNA) but also other gene mutational status may be useful as biomarkers of epidermal growth factor receptor inhibitors for NeoRAS WT mCRC. METHODS AND ANALYSIS: This trial is a multicentre, single-arm, phase II trial to assess the efficacy and safety of panitumumab plus irinotecan therapy for patients with NeoRAS mCRC. The key eligibility criteria include RAS mutant mCRC initially proven in tumour tissue refractory or intolerant to fluoropyrimidine, oxaliplatin and irinotecan; RAS WT in ctDNA (defined as plasma mutant allele frequencies of all RAS ≤0.1%) within 28 days before enrolment and Eastern Cooperative Oncology Group performance status ≤2. The primary endpoint is the response rate. The target sample size is 30 patients. Biomarker analyses are planned to be performed using next-generation sequencing-based ctDNA analysis. ETHICS AND DISSEMINATION: This study was approved by the certified review board of National Cancer Center Hospital. The main results of the trial will be presented in international meetings and in medical journals. TRIAL REGISTRATION NUMBER: s031210565.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase II as TopicErbB ReceptorsHumansIrinotecanMulticenter Studies as TopicPanitumumabProgression-Free SurvivalProto-Oncogene Proteins p21(ras)ErbB ReceptorsIrinotecanPanitumumabProto-Oncogene Proteins p21(ras)chemotherapygastrointestinal tumours

Identifiers

PMID36581973
PMCPMC9438189
OpenAlexW4294051856

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.