Evidence map›Paper›PMID 39920700›Full record

Trial reportRadiation oncology (London, England)2025

Phase II clinical trial assessing the addition of hyperthermia to salvage concurrent chemoradiotherapy for unresectable recurrent head and neck cancer in previously irradiated patients.

Kai-Lin Yang, Mau-Shin Chi, Chung-Yu Hao, Hui-Ling Ko, Yi-Ying Huang, Ren-Hong Wu, Hung-Chih Lai, Ying-Chu Lin, Sheng-Po Hao, Kwan-Hwa Chi

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

Trial report in Radiation oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02567383 (A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT02567383 phase2unknown statusnot on this map

A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer

TypeinterventionalSponsorShin Kong Wu Ho-Su Memorial HospitalRan2015 to 2021Enrolled45ConditionsRecurrent Head and Neck CancerArmsRadiation, Hyperthermia, Thermotron RF-8, Cisplatin, Taxotere
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. 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

10 authors.

Kai-Lin YangDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan.
Mau-Shin ChiDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan.
Chung-Yu HaoDepartment of Otolaryngology Head and Neck Surgery, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Hui-Ling KoDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan.
Yi-Ying HuangDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan.
Ren-Hong WuDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan.
Hung-Chih LaiDepartment of Hematology and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Ying-Chu LinDepartment of Hematology and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Sheng-Po HaoSchool of Medicine, Fu Jen Catholic University, No. 510, Chung-Cheng Road, Hsin-Chuang, New Taipei City, Taiwan.
Kwan-Hwa ChiDepartment of Radiation Therapy and Oncology, Shin Kong Wu Ho-Su Memorial Hospital, No. 95, Wen-Chang Road, Shih-Lin District, Taipei, Taiwan. M006565@ms.skh.org.tw.

Funding

Shin Kong Wu Ho-Su Memorial Hospital 2018SKHADR027
6 · The paper itself

Abstract

backgroundThis single-arm phase II trial aimed to assess the effectiveness and safety of incorporating hyperthermia into salvage concurrent chemoradiotherapy (CCRT) for previously irradiated unresectable recurrent head and neck cancer.

methodsWe enrolled patients with non-metastatic recurrent head and neck cancer who had previously undergone radiotherapy (RT) and were unfit for salvage surgery. Eligible patients received hyperthermia during salvage CCRT. RT consisted of an upfront boost with 10 Gy in 2 fractions to gross tumor volume, followed by 40 Gy in 20 fractions to clinical target volume, for a total of 50 Gy in 22 fractions. Weekly hyperthermia for 6 sessions started after RT initiation; each session lasted for 40 min, beginning within 2 h after RT and maintaining a maximum temperature of 42 ± 0.5 °C. Concurrent chemotherapy included weekly cisplatin 20 mg/m

resultsAmong 35 eligible patients, ORR was 82.9%, with complete response in 54.3%, partial response in 28.6%, stable disease in 11.4%, and progressive disease in 5.7%. After a median follow-up of 2.7 years, median OS was 32.8 months (95% confidence interval [CI], 16.7-48.9), and 2-year OS was 57.1% (95% CI, 40.6-73.6). Median PFS was 14.9 months (95% CI, 5.7-24.1), and 2-year PFS was 34.3% (95% CI, 18.6-50.0). Acute mucositis was grade 0-1 in 68.6%, grade 2 in 25.7%, and grade 3 in 5.7%. Acute dermatitis was grade 0-1 in 85.7% and grade 2 in 14.3%. No definite burn injury occurred. Grade 3-4 leucopenia, anemia, thrombocytopenia accounted for 14.3%, 14.3%, and 8.6%, respectively. Osteonecrosis was noted in 12 patients. No grade 5 toxicity was observed.

conclusionsAdding hyperthermia to salvage CCRT greatly enhances tumor response and survival rates compared to historical re-irradiation outcomes for previously irradiated unresectable recurrent head and neck cancer, with manageable toxicities.

trial registrationClinicalTrials.gov (Identifier: NCT02567383 ), Registered October 1 , 201 5 - https://www. CLINICALTRIALS: gov/study/NCT02567383.

Indexed as

ChemoradiotherapyHead and Neck NeoplasmsHyperthermia, InducedNeoplasm Recurrence, LocalSalvage TherapyAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinFemaleHumansMaleMiddle AgedPrognosisSurvival RateCisplatinConcurrent chemoradiotherapyHyperthermiaRecurrent head and neck cancer

Identifiers

PMID39920700
PMCPMC11806545

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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.