Evidence map›Paper›PMID 22585691›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection.

Stephen R Smalley, Jacqueline K Benedetti, Daniel G Haller, Scott A Hundahl, Norman C Estes, Jaffer A Ajani, Leonard L Gunderson, Bryan Goldman, James A Martenson, J Milburn Jessup and 3 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 399 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
399citing papers in PubMed, 13 pooled it
57.4field-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.

NCT03680261 phase3unknown statusnot on this mapstarted 2018, after this paper: background citation

Phase III Multicenter Randomized Controlled Trial of Adjuvant Chemoradiotherapy vs Chemotherapy for Radical Resected Advanced Gastric Carcinoma Concurrent With Lymph Node Metastasis and Lymphovascular Invasion

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2018 to 2023Enrolled556ConditionsGastric CancerArmschemoradiotherapy, chemotherapy
NCT05346874 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Prospective, Phase 2, Single Arm Trial.

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2025Enrolled37ConditionsGastric CancerArmsOxaliplatin, Teysuno, Transarterial chemoembolization (TACE)
NCT05396326 phase1unknown statusnot on this mapstarted 2022, after this paper: background citation

Neoadjuvant Transcatheter Arterial Chemoinfusion and Embolism (TACiE) for Patients With Locally Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction: a Pilot Study

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2025Enrolled20ConditionsGastric CancerArmsOxaliplatin, Teysuno, Transarterial arterial chemoinfusion and embolism (TACiE)
NCT07565857 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

SIGNAL GEC-101: Signatera-Guided De-escalation of Adjuvant Therapy in Resectable Stage II-IVa Gastric/Gastric-Esophageal Cancer

TypeinterventionalSponsorNatera, Inc.Ran2026 to 2034Enrolled1,000ConditionsGastric-Esophageal CancerArmsSignatera Genome ultra-sensitive ctDNA blood test
3 · Its place in the literature

Who cites it

399 citing papers in PubMed, 13 syntheses or guidelines pooled it, 852 citations in OpenAlex.

  1. Pooled it
  2. Health utility book: A systematic review and meta-analysis of health utilities in gastric cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
  3. SEOM-GEMCAD-TTD clinical guideline for the diagnosis and treatment of gastric cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
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  11. Adjuvant radiochemotherapy vs. chemotherapy alone in gastric cancer: a meta-analysis.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2019
    Pooled it
  12. Pooled it
  13. Pooled it
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Observational
  20. Review

339 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Stephen R SmalleyRadiation Oncology Center of Olathe, 20375 West 151st St, Suite 180, Olathe, KS 66061, USA. s_smalley@msn.com
Jacqueline K Benedetti
Daniel G Haller
Scott A Hundahl
Norman C Estes
Jaffer A Ajani
Leonard L Gunderson
Bryan Goldman
James A Martenson
J Milburn Jessup
Grant N Stemmermann
Charles D Blanke
John S Macdonald
Mayo Clinic · USMayo Clinic in Arizona · USNational Institutes of Health · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA015488NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035192NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035262NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045450NCI NIH HHS U10 CA045461NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058348NCI NIH HHS U10 CA058416NCI NIH HHS U10 CA058686NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA067663NCI NIH HHS U10 CA076447
6 · The paper itself

Abstract

purposeSurgical resection of gastric cancer has produced suboptimal survival despite multiple randomized trials that used postoperative chemotherapy or more aggressive surgical procedures. We performed a randomized phase III trial of postoperative radiochemotherapy in those at moderate risk of locoregional failure (LRF) following surgery. We originally reported results with 4-year median follow-up. This update, with a more than 10-year median follow-up, presents data on failure patterns and second malignancies and explores selected subset analyses. PATIENTS AND

methodsIn all, 559 patients with primaries ≥ T3 and/or node-positive gastric cancer were randomly assigned to observation versus radiochemotherapy after R0 resection. Fluorouracil and leucovorin were administered before, during, and after radiotherapy. Radiotherapy was given to all LRF sites to a dose of 45 Gy.

resultsOverall survival (OS) and relapse-free survival (RFS) data demonstrate continued strong benefit from postoperative radiochemotherapy. The hazard ratio (HR) for OS is 1.32 (95% CI, 1.10 to 1.60; P = .0046). The HR for RFS is 1.51 (95% CI, 1.25 to 1.83; P < .001). Adjuvant radiochemotherapy produced substantial reduction in both overall relapse and locoregional relapse. Second malignancies were observed in 21 patients with radiotherapy versus eight with observation (P = .21). Subset analyses show robust treatment benefit in most subsets, with the exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect.

conclusionIntergroup 0116 (INT-0116) demonstrates strong persistent benefit from adjuvant radiochemotherapy. Toxicities, including second malignancies, appear acceptable, given the magnitude of RFS and OS improvement. LRF reduction may account for the majority of overall relapse reduction. Adjuvant radiochemotherapy remains a rational standard therapy for curatively resected gastric cancer with primaries T3 or greater and/or positive nodes.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapy, AdjuvantFemaleFluorouracilGastrectomyHumansLeucovorinMaleStomach NeoplasmsSurvival AnalysisTreatment OutcomeFluorouracilLeucovorin

Identifiers

PMID22585691
PMCPMC4517071
OpenAlexW2144182296

What OpenQuestion holds

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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.