Evidence map›Paper›PMID 26213360›Full record

Trial reportJournal of the American College of Surgeons2015

Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial.

Mladjan Protic, Alexander Stojadinovic, Aviram Nissan, Zev Wainberg, Scott R Steele, David C Chen, Itzhak Avital, Anton J Bilchik

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Surgeons, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00949312 (Ultrastaging of Early Colon Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT00949312 unknown statusnot on this map

Ultrastaging of Early Colon Cancer

TypeobservationalSponsorSaint John's Cancer InstituteRan2009 to 2023Enrolled26ConditionsColorectal CancerArmsRNA marker analysis of lymph node and primary tumors, microarray profiling of primary tumors, reverse transcriptase-polymerase chain reaction of lymph node specimens, diagnostic laboratory RNA and DNA biomarker analysis of primary tumors, regional lymph node dissection
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Review
  3. Identification of nodal micrometastasis in colorectal cancer using deep learning on annotation-free whole-slide images.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2021
    Article
  4. Article
  5. Challenges with colorectal cancer staging: results of an international study.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2020
    Article
  6. Review
  7. Nanotechnology and Pediatric Cancer: Prevention, Diagnosis and Treatment.Iranian journal of pediatric hematology and oncology · 2015
    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

8 authors.

Mladjan ProticClinic of Surgical Oncology, Oncology Institute of Vojvodina, Sremska Kamenica, Serbia; University of Novi Sad - Faculty of Medicine, Novi Sad, Serbia.
Alexander StojadinovicUniformed Services University of the Health Sciences, Bethesda, MD.
Aviram NissanSheba General Hospital, The Chaim Sheba Medical Center, Tel-Hashomer, Israel.
Zev WainbergUniversity of California, Los Angeles, Los Angeles, CA.
Scott R SteeleMadigan Army Medical Center, Tacoma, WA; University Hospitals, Case Western Reserve University, Cleveland, OH.
David C ChenUniversity of California, Los Angeles, Los Angeles, CA.
Itzhak AvitalUniformed Services University of the Health Sciences, Bethesda, MD.
Anton J BilchikUniversity of California, Los Angeles, Los Angeles, CA; John Wayne Cancer Institute at Providence Saint John's Health Center, Santa Monica, CA; California Oncology Research Institute, Santa Monica, CA. Electronic address: bilchika@jwci.org.

Funding

Ultrastaging of Early Colon CancerR01CA090848 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI BILCHIK, ANTON J · 2001 to 2012
$3.5M
NCI NIH HHS R01 CA090848
6 · The paper itself

Abstract

backgroundWe recently reported, in a prospective randomized trial, that ultra-staging of patients with colon cancer is associated with significantly improved disease-free survival (DFS) compared with conventional staging. That trial did not control for lymph node (LN) number or adjuvant chemotherapy use. STUDY

designThe current international prospective multicenter cooperative group trial (ClinicalTrials.gov identifier NCT00949312; "Ultra-staging in Early Colon Cancer") evaluates the 12-LN quality measure and nodal ultra-staging impact on DFS in patients not receiving adjuvant chemotherapy. Eligibility criteria included biopsy-proven colon adenocarcinoma; absence of metastatic disease; >12 LNs staged pathologically; pan-cytokeratin immunohistochemistry (IHC) of hematoxylin and eosin (H&E)-negative LNs; and no adjuvant chemotherapy.

resultsOf 445 patients screened, 203 patients were eligible. The majority of patients had intermediate grade (57.7%) and T3 tumors (64.9%). At a mean follow-up of 36.8 ± 22.1 months (range 0 to 97 months), 94.3% remain disease free. Recurrence was least likely in patients with ≥12 LNs, H&E-negative LNs, and IHC-negative LNs (pN0i-): 2.6% vs 16.7% in the pN0i+ group (p < 0.0001).

conclusionsThis is the first prospective report to demonstrate that patients with optimally staged node-negative colon cancer (≥12 LNs, pN0i-) are unlikely to benefit from adjuvant chemotherapy; 97% remain disease free after primary tumor resection. Both surgical and pathologic quality measures are imperative in planning clinical trials in nonmetastatic colon cancer.

Indexed as

AdenocarcinomaAgedAged, 80 and overChemotherapy, AdjuvantColectomyColonic NeoplasmsDisease-Free SurvivalFemaleHumansLymph NodesMaleMiddle AgedNeoplasm StagingPrognosisProspective Studies

Identifiers

PMID26213360
PMCPMC4657939

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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.