Evidence map›Paper›PMID 38492812›Full record

Trial reportInternational journal of radiation oncology, biology, physics2024

Radiation Therapy Quality Assurance Analysis of Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Pancreas.

Leila T Tchelebi, Diana Segovia, Koren Smith, Qian Shi, T J Fitzgerald, Michael D Chuong, Tyler J Zemla, Eileen M O'Reilly, Jeffrey A Meyerhardt, Eugene J Koay and 4 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Surgical Outcomes Following Neoadjuvant Treatment for Locally Advanced and Borderline Resectable Pancreatic Ductal Adenocarcinoma.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2024
    Article
  12. Article
  13. Article
  14. Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer.Clinical and experimental gastroenterology · 2024
    Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

14 authors at 8 institutions in 1 country.

Leila T TchelebiNorthwell, New Hyde Park, New York. Electronic address: tchelebi@gmail.com.
Diana SegoviaAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.
Koren SmithUniversity of Massachusetts Chan Medical School, Worcester, Massachusetts.
Qian ShiAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.
T J FitzgeraldUniversity of Massachusetts Chan Medical School, Worcester, Massachusetts.
Michael D ChuongMiami Cancer Institute, Baptist Health South Florida, Miami, Florida.
Tyler J ZemlaAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.
Eileen M O'ReillyMemorial Sloan Kettering Cancer Center, New York, New York.
Jeffrey A MeyerhardtDana Farber Cancer Institute, Boston, Massachusetts.
Eugene J KoayUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Jessica LowensteinUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Ardaman ShergillUniversity of Chicago, Chicago, Illinois.
Matthew H G KatzUniversity of Texas MD Anderson Cancer Center, Houston, Texas.
Joseph M HermanNorthwell, New Hyde Park, New York.
Mayo Clinic · USThe University of Texas MD Anderson Cancer Center · USNorthwell Health · USUniversity of Massachusetts Chan Medical School · USBaptist Hospital of Miami · USDana-Farber Cancer Institute · USMemorial Sloan Kettering Cancer Center · USUniversity of Chicago · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Northwell Health NCORPUG1CA189850 · NCI · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI VINCENT P VINCIGUERRA · 2014 to 2026
$13.3M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180882NCI NIH HHS U24 CA180803NCI NIH HHS UG1 CA189850NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233329
6 · The paper itself

Abstract

purposeAlliance A021501 is the first randomized trial to evaluate stereotactic body radiation therapy (SBRT) for borderline resectable pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant chemotherapy. In this post hoc study, we reviewed the quality of radiation therapy (RT) delivered. METHODS AND MATERIALS: SBRT (6.6 Gy × 5) was intended but hypofractionated RT (5 Gy × 5) was permitted if SBRT specifications could not be met. Institutional credentialing through the National Cancer Institute-funded Imaging and Radiation Oncology Core (IROC) was required. Rigorous RT quality assurance (RT QA) was mandated, including pretreatment review by a radiation oncologist. Revisions were required for unacceptable deviations. Additionally, we performed a post hoc RT QA analysis in which contours and plans were reviewed by 3 radiation oncologists and assigned a score (1, 2, or 3) based on adequacy. A score of 1 indicated no deviation, 2 indicated minor deviation, and 3 indicated a major deviation that could be clinically significant. Clinical outcomes were compared by treatment modality and by case score.

resultsForty patients were registered to receive RT (1 planned but not treated) at 27 centers (18 academic and 9 community). Twenty-three centers were appropriately credentialed for moving lung/liver targets and 4 for static head and neck only. Thirty-two of 39 patients (82.1%) were treated with SBRT and 7 (17.9%) with hypofractionated RT. Five cases (13%) required revision before treatment. On post hoc review, 23 patients (59.0%) were noted to have suboptimal contours or plan coverage, 12 (30.8%) were scored a 2, and 11 (28.2%) were scored a 3. There were no apparent differences in failure patterns or surgical outcomes based on treatment technique or post hoc case score. Details related to on-treatment imaging were not recorded.

conclusionsDespite rigorous QA, we encountered variability in simulation, contouring, plan coverage, and dose on trial. Although clinical outcomes did not appear to have been affected, findings from this analysis serve to inform subsequent PDAC SBRT trial designs and QA requirements.

Indexed as

FluorouracilPancreatic NeoplasmsQuality Assurance, Health CareRadiation Dose HypofractionationRadiosurgeryAdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalFemaleHumansIrinotecanLeucovorinMaleNeoadjuvant TherapyOxaliplatinRadiotherapy Planning, Computer-AssistedFluorouracilfolfirinoxIrinotecanLeucovorinOxaliplatin

Identifiers

PMID38492812
PMCPMC11329353
OpenAlexW4392859777

What OpenQuestion holds

Textmetadata
LicenceTDM
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.