Evidence map›Paper›PMID 20975604›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2010

Phase II study of preoperative pemetrexed, carboplatin, and radiation followed by surgery for locally advanced esophageal cancer and gastroesophageal junction tumors.

Aminah Jatoi, Gamini Soori, Nathan R Foster, Bradley K Hiatt, James A Knost, Tom R Fitch, Matthew D Callister, Francis C Nichols, Tim M Husted, Steven R Alberts

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00268437 (A Phase II Trial of Preoperative Radiation and Chemotherapy), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00268437 phase2terminatednot on this map

A Phase II Trial of Preoperative Radiation and Chemotherapy (Pemetrexed and Carboplatin) for Locally Advanced Esophageal Cancer

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2006 to 2015Enrolled27ConditionsEsophageal CancerArmscarboplatin, Pemetrexed, conventional surgery, neoadjuvant therapy, radiation therapy
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
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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

10 authors.

Aminah JatoiDepartment of Oncology, Mayo Clinic Rochester, Rochester, Minnesota 55905, USA. Jatoi.aminah@mayo.edu
Gamini Soori
Nathan R Foster
Bradley K Hiatt
James A Knost
Tom R Fitch
Matthew D Callister
Francis C Nichols
Tim M Husted
Steven R Alberts

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
SIOUX COMMUNITY CANCER CONSORTIUMU10CA035103 · NCI · UNIVERSITY OF SOUTH DAKOTA · PI MAZURCZAK, MIROSLAW · 1985 to 2014
$11.6M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
IOWA ONCOLOGY RESEARCH ASSOCIATION CCOPU10CA035101 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI BEHRENS, ROBERT J. · 1985 to 2014
$10.1M
Mentoring and Research in Cancer Palliative CareK24CA131099 · NCI · MAYO CLINIC ROCHESTER · PI JATOI, AMINAH · 2008 to 2012
$873k
NCI NIH HHS CA-25224NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35267NCI NIH HHS CA-37404NCI NIH HHS K24 CA131099NCI NIH HHS K24CA131099NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

introductionBased on favorable preliminary clinical data and the need to identify effective, well-tolerated neoadjuvant regimens for patients with locally advanced esophageal cancer, this clinical trial was undertaken.

methodsThis phase II study tested 500 mg/m neoadjuvant pemetrexed intravenously and carboplatin with an area under the curve of 6 intravenously on days 1 and 22 in conjunction with concomitant radiation of 5040 centigray, which was given in 28 daily fractions of 180 centigray. The primary endpoint was the rate of pathologic complete response.

resultsThis trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Twenty (74%) were men. Performance scores of 0, 1, and 2 were seen in 16 (59%), 9 (33%), and 2 (7%), respectively. Among eligible patients, 6 of 26 (23%; 95% confidence interval 9-44%) demonstrated a pathologic complete response. Twenty-two underwent a complete cancer resection. The median survival was 17.8 months (95% confidence interval: 12.2-30.7 months). In the neoadjuvant setting, 22 patients had at least one grade 3 or worse adverse event, and 8 patients had at least one grade 4 event. Postoperatively (within 30 days of surgery), there were three deaths, one grade 4 event (thrombosis), and three grade 3 events.

conclusionsThe neoadjuvant regimen tested within this phase II trial demonstrated antineoplastic activity but fell short of yielding a complete pathologic response rate that merits further testing.

Indexed as

Esophagogastric JunctionAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCombined Modality TherapyEsophageal NeoplasmsFemaleGlutamatesGuanineHumansMaleMiddle AgedPemetrexedRadiotherapy DosageCarboplatinGlutamatesGuaninePemetrexed

Identifiers

PMID20975604
PMCPMC5593750

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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.