Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02567383|
Recruitment Status : Unknown
Verified July 2020 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was: Recruiting
First Posted : October 5, 2015
Last Update Posted : July 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Head and Neck Cancer||Radiation: Radiation Device: Hyperthermia; Thermotron RF-8 Drug: Cisplatin Drug: Taxotere||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
5-Gy once a week for a subtotal of 10Gy/2fx a week to gross tumors, followed by 40Gy/20fx/4 weeks, total 50Gy/22fx/5weeks
Device: Hyperthermia; Thermotron RF-8
40 minutes within 2hr after irradiation
20mg/m2 per week for 6 weekly cycles before radiotherapy
10-12mg/m2 per week for 6 weekly cycles before radiotherapy
- Tumor response rate [ Time Frame: 12 Weeks ]To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1) using hyperthermia combined with CCRT for recurrent head and neck cancer.
- Adverse events [ Time Frame: Within 3 months ]To estimate rates of each grade adverse events (CTCAE, version 4.0) which is possibly, probably, or definitely related to treatment and which occurs within 3 months from the start of radiation combined with hyperthermia and chemotherapy.
- Late adverse events [ Time Frame: After 3 months ]To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567383
|Contact: Kwan-Hwa Chi, M.D.||886-2-28332211 ext 2274||M006565@ms.skh.org.tw|
|Contact: Kai-Lin Yang, M.D.||886-2-28332211 ext 2275||M011360@ms.skh.org.tw|