Evidence map›Paper›PMID 20888709›Full record

Trial reportInternational journal of radiation oncology, biology, physics2011

Phase III study of radiation therapy with or without cis-platinum in patients with unresectable squamous or undifferentiated carcinoma of the head and neck: an intergroup trial of the Eastern Cooperative Oncology Group (E2382).

Harry Quon, Traci Leong, Robert Haselow, Bruce Leipzig, Jay Cooper, Arlene Forastiere

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06536699 (A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers), which is not on this map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT06536699 nanot yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomised Non Inferiority Trial to Compare the Average Global Quality of Life Score Following Hypofractionated Radiotherapy Versus Conventional Fractionation in Head and Neck Cancers

TypeinterventionalSponsorTata Medical CenterRan2024 to 2031Enrolled600ConditionsRadiation TreatmentArmsRadiotherapy - hypofractionated, Radiotherapy - Conventional
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Guideline
  2. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 107 randomized trials and 19,805 patients, on behalf of MACH-NC Group.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021
    Pooled it
  3. Pooled it
  4. Systemic therapy in the curative treatment of head and neck squamous cell cancer: a systematic review.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2017
    Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. The changing therapeutic landscape of head and neck cancer.Nature reviews. Clinical oncology · 2019
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. The impact of cumulative dose of cisplatin on outcome of patients with head and neck squamous cell carcinoma.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2017
    Article
  20. 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

6 authors at 6 institutions in 1 country.

Harry QuonHospital of the University of Pennsylvania, 3400 Spruce Street –2 Donner, Philadelphia, PA 19104, USA. quon@xrt.upenn.edu
Traci Leong
Robert Haselow
Bruce Leipzig
Jay Cooper
Arlene Forastiere
Emory University · USHospital of the University of Pennsylvania · USJohns Hopkins University · USMaimonides Medical Center · USMetro-Minnesota Community Oncology Research Consortium · USUniversity of Arkansas for Medical Sciences · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
NCI NIH HHS CA16116NCI NIH HHS CA21115NCI NIH HHS CA21661NCI NIH HHS CA23318NCI NIH HHS CA37422NCI NIH HHS CA66636NCI NIH HHS N01 CA032102NCI NIH HHS P30 CA006973NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA066636
6 · The paper itself

Abstract

purposeThe Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma. METHODS AND MATERIALS: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m(2). Failure-free survival (FFS) and overall survival (OS) curves were estimated with the Kaplan-Meier method and compared with the log rank test.

resultsBetween 1982 and 1987, 371 patients were accrued, and 308 patients were found eligible for analysis. Median follow-up was 62 months. The median FFS was 6.5 and 7.2 months for the RT and RT + cisplatin groups, respectively (p = 0.30). The p value for the treatment difference was p = 0.096 in multivariate modeling of FFS (compared to a p = 0.30 in univariate analysis). Expected acute toxicities were significantly increased with the addition of cisplatin except for in-field RT toxicities. Late toxicities were not significantly different except for significantly more esophageal (9% vs. 3%, p = 0.03) and laryngeal (11% vs. 4%, p = 0.05) late toxicities in the RT + cisplatin group.

conclusionThe addition of concurrent weekly cisplatin at 20 mg/m(2) to daily radiation did not improve survival, although there was evidence of activity. Low-dose weekly cisplatin seems to have modest tumor radiosensitization but can increase the risk of late swallowing complications.

Indexed as

AdultAgedAged, 80 and overAnalysis of VarianceAntineoplastic AgentsCarcinoma, Squamous CellCisplatinDisease-Free SurvivalDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm StagingRadiation-Sensitizing AgentsAntineoplastic AgentsCisplatinRadiation-Sensitizing Agents

Identifiers

PMID20888709
PMCPMC3612971
OpenAlexW2058760813

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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.