Evidence map›Paper›PMID 36622529›Full record

Trial reportAnnals of surgical oncology2023

Adjuvant Chemoradiation in Patients with Lymph Node-Positive Biliary Tract Cancers: Secondary Analysis of a Single-Arm Clinical Trial (SWOG 0809).

Sepideh Gholami, Sarah Colby, David P Horowitz, Katherine A Guthrie, Edgar Ben-Josef, Anthony B El-Khoueiry, Charles D Blanke, Philip A Philip, Lisa A Kachnic, Syed A Ahmad and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Annals of surgical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07636824 (Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT07636824 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study

TypeinterventionalSponsorCancer Institute and Hospital, Chinese Academy of Medical SciencesRan2026 to 2029Enrolled92ConditionsExtrahepatic Cholangiocarcinoma and Gallbladder CarcinomaArmsPostoperative radiotherapy, Capecitabine or S-1
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Role of Radiation Therapy for Biliary Tract Cancers.Current oncology (Toronto, Ont.) · 2025
    Review
  3. Article
  4. New trends in diagnosis and management of gallbladder carcinoma.World journal of gastrointestinal oncology · 2024
    Review
  5. Article
  6. 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

11 authors at 9 institutions in 1 country.

Sepideh GholamiDepartment of Surgery, University of California, Davis, CA, USA. sgholami@northwell.edu.
Sarah ColbySWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA, USA.
David P HorowitzDepartment of Radiation Oncology, Columbia University Irving Medical Center, New York City, NY, USA.
Katherine A GuthrieSWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Edgar Ben-JosefDepartment of Radiation Oncology, University of Pennsylvania, Philadelphia, PA, USA.
Anthony B El-KhoueiryDepartment of Clinical Medicine, University of Southern California, Los Angeles, CA, USA.
Charles D BlankeSWOG Group Chair's Office, Oregon Health Sciences University, Knight Cancer Institute, Portland, OR, USA.
Philip A PhilipDepartment of Oncology and Department of Pharmacology, School of Medicine, Wayne State University, Karmanos Cancer Center, Detroit, MI, USA.
Lisa A KachnicDepartment of Radiation Oncology, Columbia University Irving Medical Center, New York City, NY, USA.
Syed A AhmadDepartment of Surgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.
Flavio G RochaDivision of Surgical Oncology, Oregon Health Sciences University, Knight Cancer Institute, Portland, OR, USA.
Fred Hutch Cancer Center · USOregon Health & Science University · USColumbia University Irving Medical Center · USHerbert Irving Comprehensive Cancer CenterUniversity of California, Davis · USUniversity of Cincinnati · USUniversity of Pennsylvania · USUniversity of Southern California · USWayne State University · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundSWOG 0809 is the only prospective study of adjuvant chemotherapy followed by chemoradiation focusing on margin status in patients with extrahepatic cholangiocarcinoma (EHCC) and gallbladder cancer (GBCA); however, the effects of adjuvant therapy by nodal status have never been reported in this population.

methodsPatients with resected EHCC and GBCA, stage pT2-4, node-positive (N+) or margin-positive (R1) who completed four cycles of chemotherapy followed by radiotherapy were included. Cox regression was used to compare overall survival (OS), disease-free survival (DFS), local recurrence, and distant metastasis by nodal status. DFS rates were compared with historical data via a one-sample t-test.

resultsSixty-nine patients [EHCC, n = 46 (66%); GBCA, n = 23 (33%)] were evaluated, with a median age of 61.7 years and an R0 rate of 66.7% and R1 rate of 33.3%. EHCC versus GBCA was more likely to be N+ (73.9% vs. 47.8%, p = 0.03). Nodal status did not significantly impact OS (hazard ratio [HR] 1.98, 95% confidence interval [CI] 0.86-4.54, p = 0.11) or DFS (HR 1.63, 95% CI 0.77-3.44, p = 0.20). Two-year OS was 70.6% for node-negative (N0) disease and 60.9% for N+ disease, while 2-year DFS was 62.5% for N0 tumors and 49.8% for N+ tumors. N+ versus N0 tumors showed higher rates of distant failure (42.2% vs. 25.0%, p = 0.04). The 2-year DFS rate in N+ tumors was significantly higher than in historical controls (49.8% vs. 29.7%, p = 0.004).

conclusionsAdjuvant therapy is associated with favorable outcome independent of nodal status and may impact local control in N+ patients. These data could serve as a benchmark for future adjuvant trials, including molecular-targeted agents.

Indexed as

Bile Duct NeoplasmsCholangiocarcinomaGallbladder NeoplasmsBile Ducts, IntrahepaticChemoradiotherapy, AdjuvantChemotherapy, AdjuvantHumansLymph NodesMiddle AgedProspective Studies

Identifiers

PMID36622529
PMCPMC10695673
OpenAlexW4313857778

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.