Evidence map›Paper›PMID 28721881›Full record

Trial reportInternational journal of radiation oncology, biology, physics2017

Final Report of a Prospective Randomized Trial to Evaluate the Dose-Response Relationship for Postoperative Radiation Therapy and Pathologic Risk Groups in Patients With Head and Neck Cancer.

David I Rosenthal, Abdallah S R Mohamed, Adam S Garden, William H Morrison, Adel K El-Naggar, Mona Kamal, Randal S Weber, Clifton D Fuller, Lester J Peters

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 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.

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

44 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  5. Review
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  12. Treatment package time in high-risk oral cavity squamous cell carcinoma: where are we failing and at what cost?Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2025
    Article
  13. Review
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  15. Clinical outcomes and failure patterns after postoperative radiotherapy for oral cavity squamous cell carcinoma.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024
    Article
  16. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

David I RosenthalDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: dirosenthal@mdanderson.org.
Abdallah S R MohamedDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, University of Alexandria, Alexandria, Egypt.
Adam S GardenDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
William H MorrisonDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Adel K El-NaggarDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Mona KamalDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Radiation Oncology, Ain Shams University, Cairo, Egypt.
Randal S WeberDepartment of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Clifton D FullerDepartment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Lester J PetersDepartment of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Targeting the p53 pathway for reversal of oral premalignancyP50CA097007 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI MYERS, JEFFREY NICHOLAS · 2002 to 2012
$26.1M
Paul Calabresi Clinical Oncology AwardK12CA088084 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI David S. Hong, Scott Kopetz · 2000 to 2026
$14.0M
Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Establish Objective Clinical Outcome Measures for Mandibular OsteoradionecrosisR01DE025248 · NIDCR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI LAI, STEPHEN Y · 2016 to 2020
$2.9M
Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced XerostomiaR01CA148707 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI COHEN, LORENZO · 2011 to 2014
$2.7M
Community-Based, Phase III Trial of acupuncture to treat chronic XerostomiaR01CA160880 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI COHEN, LORENZO · 2012 to 2017
$1.8M
SMART-ACT: Spatial Methodologic Approaches for Risk Assessment and Therapeutic Adaptation in Cancer TreatmentR01CA214825 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI CANAHUATE, GUADALUPE, FULLER, CLIFTON DAVID · 2017 to 2019
$1.1M
Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Establish Objective Clinical Outcome Measures for Mandibular OsteoradionecrosisR56DE025248 · NIDCR · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI LAI, STEPHEN Y · 2015 to 2015
$470k
NCI NIH HHS K12 CA088084NCI NIH HHS L30 CA136381NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA097007NCI NIH HHS R01 CA148707NCI NIH HHS R01 CA160880NCI NIH HHS R01 CA214825NIDCR NIH HHS R01 DE025248NIDCR NIH HHS R56 DE025248
6 · The paper itself

Abstract

purposeTo present the long-term and final report of a phase 3 trial designed to assess dose-response relationship for postoperative radiation therapy (PORT) and pathologic risk groups in head and neck cancer. METHODS AND MATERIALS: Patients who underwent primary surgery for American Joint Committee on Cancer stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and who required PORT were eligible. Patients' primary sites and involved necks were independently assigned to higher- or lower-risk categories based on a cumulative point score representing increasing risk of recurrence. The sites in the lower-risk group were randomized to receive 57.6 or 63 Gy and those in the higher-risk group were randomized to receive 63 or 68.4 Gy, all at 1.8 Gy per fraction.

resultsA total of 264 patients were included. The actuarial 5-year locoregional control rate was 67%. A second primary cancer was documented in 27% of patients. The 5- and 10-year freedom-from-distant metastasis rates were 64% and 60%, respectively, whereas the 5- and 10-year overall survival rates were 32% and 20%, respectively. There was no statistically significant difference in tumor control between different dose levels in both the lower- and higher-risk groups. On multivariate analysis, nonwhite race (P=.0003), positive surgical margins (P=.009), extracapsular extension (ECE, P=.01), and treatment package time (TPT) ≥85 days (P=.002) were independent correlates of worse locoregional control, whereas age ≥57 years (P<.0001), positive surgical margins (P=.01), ECE (P=.026), and TPT ≥85 days (P=.003) were independently associated with worse overall survival.

conclusionsThis long-term report of PORT delivered at 1.8 Gy/d to total doses of 57.6 to 68.4 Gy without chemotherapy for head and neck squamous cell carcinoma demonstrated that increasing dose did not significantly improve tumor control. On multivariate analysis, the only significant treatment variable was TPT. The results confirm that positive surgical margins and/or nodal ECE remains the most significant predictive pathologic factors.

Indexed as

AdultAgedAged, 80 and overAnalysis of VarianceCarcinoma, Squamous CellDose-Response Relationship, RadiationFemaleHead and Neck NeoplasmsHumansHypopharyngeal NeoplasmsKaplan-Meier EstimateLaryngeal NeoplasmsMaleMargins of ExcisionMiddle AgedMouth Neoplasms

Identifiers

PMID28721881
PMCPMC5518636

What OpenQuestion holds

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Registered trials

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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.