Evidence map›Paper›PMID 19828593›Full record

ReviewThe oncologist2009

NCCTG Study N9741: leveraging learning from an NCI Cooperative Group phase III trial.

Richard M Goldberg, Daniel J Sargent, Roscoe F Morton, Erin Green, Hanna K Sanoff, Howard McLeod, Jan Buckner

Registry-linked trialOpen access · greenAbstract readReview
In one paragraph

Review in The oncologist, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003594 (A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT00003594 phase3completednot on this map

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan1998 to 2004Enrolled1,691ConditionsColorectal CancerArmsirinotecan, fluorouracil, leucovorin calcium, oxaliplatin
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Article
  4. Article
  5. Review
  6. 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

7 authors at 3 institutions in 1 country.

Richard M GoldbergLineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, CB 7305, 170 Manning Drive, Chapel Hill, North Carolina 27599, USA. goldberg@med.unc.edu
Daniel J Sargent
Roscoe F Morton
Erin Green
Hanna K Sanoff
Howard McLeod
Jan Buckner
University of North Carolina at Chapel Hill · USUniversity of Rochester · USIowa Oncology Research Association · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
North Central Cancer Treatment Group (NCCTG) Biospecimen ResourceU24CA114740 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 2005 to 2014
$8.6M
NCI NIH HHS CA114740NCI NIH HHS CA25224NCI NIH HHS U10 CA025224NCI NIH HHS U24 CA114740
6 · The paper itself

Abstract

N9741 is a clinical trial in patients with metastatic colorectal cancer that was originally written in 1997 and completed patient accrual in 2004. One thousand seven hundred thirty-one patients were enrolled in the study. During the conduct of the trial, N9741 was repeatedly modified to adapt to toxicity findings, to add evaluation of oxaliplatin to what was originally a trial examining various schedules of irinotecan-based therapy, and to ask evolving questions. The trial led to a new U.S. Food and Drug Administration indication for 5-fluorouracil, leucovorin, and oxaliplatin as indicated for the treatment of previously untreated patients with metastatic colorectal cancer and helped to change the standard of care for the disease in the U.S. and worldwide. The data from the trial have been used to study multiple regimens, pharmacogenetics, and quality of life issues, to correlate plasma protein levels with outcomes, to inform trial methodology, and to perform economic analyses. To date nearly 30 papers and an even larger number of abstracts have been based upon data arising from the study. The history of the trial and the major findings are summarized in this review.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsClinical Trials as TopicClinical Trials, Phase III as TopicColorectal NeoplasmsHumansNeoplasm MetastasisQuality of LifeSurvival AnalysisTreatment Outcome

Identifiers

PMID19828593
PMCPMC2917613
OpenAlexW2130533765

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.