Evidence map›Paper›PMID 32160096›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer.

Steven H Lin, Brian P Hobbs, Vivek Verma, Rebecca S Tidwell, Grace L Smith, Xiudong Lei, Erin M Corsini, Isabel Mok, Xiong Wei, Luyang Yao and 17 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 146 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
146citing papers in PubMed, 11 pooled it
34.9field-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

146 citing papers in PubMed, 11 syntheses or guidelines pooled it, 254 citations in OpenAlex.

  1. Evidence-based indications for proton therapy in adults determined using the GRADE approach.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Pooled it
  2. Pooled it
  3. Guideline
  4. American Radium Society Appropriate Use Criteria on Cardiac Toxicity Prevention and Management After Thoracic Radiotherapy.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2024
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Health Economic Evaluation of Proton Therapy for Lung Cancer: A Systematic Review.International journal of environmental research and public health · 2023
    Pooled it
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Article
  17. Review
  18. Article
  19. Observational
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 5 institutions in 2 countries.

Steven H LinDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Brian P HobbsQuantitative Health Sciences, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.
Vivek VermaDepartment of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA.
Rebecca S TidwellDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Grace L SmithDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Xiudong LeiDepartment of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX.
Erin M CorsiniDepartment of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
Isabel MokDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Xiong WeiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Luyang YaoDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Xin WangDepartment of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.
Ritsuko U KomakiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Joe Y ChangDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Stephen G ChunDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Melenda D JeterDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Stephen G SwisherDepartment of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
Jaffer A AjaniDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Mariela Blum-MurphyDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Ara A VaporciyanDepartment of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
Reza J MehranDepartment of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
Albert C KoongDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Saumil J GandhiDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Wayne L HofstetterDepartment of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.
Theodore S HongDepartment of Radiation Oncology, Massachusetts General Hospital, Boston, MA.
Thomas F DelaneyDepartment of Radiation Oncology, Massachusetts General Hospital, Boston, MA.
Zhongxing LiaoDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Radhe MohanDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
The University of Texas MD Anderson Cancer Center · USMassachusetts General Hospital · USAllegheny General Hospital · USCleveland Clinic · USTianjin Medical University Cancer Institute and Hospital · CN

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
MDACC Clinical and Research Physics SupportU19CA021239 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI HONG, THEODORE S · 2014 to 2018
$11.2M
Economic Strain and Resilience in Cancer Patients: Assessing Patient-Reported Measures of the Burdens of TreatmentK07CA211804 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SMITH, GRACE · 2016 to 2020
$853k
NCI NIH HHS K07 CA211804NCI NIH HHS P30 CA016672NCI NIH HHS U19 CA021239
6 · The paper itself

Abstract

purposeWhether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer.

methodsThis phase IIB trial randomly assigned patients to PBT or IMRT (50.4 Gy), stratified for histology, resectability, induction chemotherapy, and stage. The prespecified coprimary end points were TTB and PFS. TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs) in operated patients, quantified the extent of AE severity experienced over the duration of 1 year following treatment. The trial was conducted using Bayesian group sequential design with three planned interim analyses at 33%, 50%, and 67% of expected accrual (adjusted for follow-up).

resultsThis trial (commenced April 2012) was approved for closure and analysis upon activation of NRG-GI006 in March 2019, which occurred immediately prior to the planned 67% interim analysis. Altogether, 145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable. Median follow-up was 44.1 months. Fifty-one patients (30 IMRT, 21 PBT) underwent esophagectomy; 80% of PBT was passive scattering. The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0). The mean POC score was 7.6 times higher for IMRT (19.1; 7.3-32.3) versus PBT (2.5; 0.3-5.2). The posterior probability that mean TTB was lower for PBT compared with IMRT was 0.9989, which exceeded the trial's stopping boundary of 0.9942 at the 67% interim analysis. The 3-year PFS rate (50.8%

conclusionFor locally advanced esophageal cancer, PBT reduced the risk and severity of AEs compared with IMRT while maintaining similar PFS.

Indexed as

AdultAgedAged, 80 and overEsophageal NeoplasmsFemaleHumansMaleMiddle AgedProton TherapyRadiotherapy, Intensity-Modulated

Identifiers

PMID32160096
PMCPMC7213588
OpenAlexW3012051758

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.