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
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|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)
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|Ages Eligible for Study:||20 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age of 20-85 years, with ECOG performance 0-2.
- Treatment failure head and neck cancer, with histologically or clinically confirmed recurrence or progression after previous treatment of radiotherapy with combinations.
- Complete surgical excision is NOT feasible as salvage treatment for the recurrent or progressive tumor(s), or the patient does NOT agree to receive the surgical procedure.
- Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
- Measurable lesions by image examinations or endoscopy within 2 months.
- The distribution of the lesions of interest does NOT exceed 20cm range.
- The patient can tolerate implementation of cisplatin and taxotere weekly therapy, with respect to hematopoietic status, renal function, liver function, allergy and other potential adverse effects.
- There is NO other effective treatment option according to the evaluation of physicians.
- Re-irradiation of 50Gy/22fx is considered NOT tolerable.
- Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
- The patient is participating in other clinical trials.
- Future regular clinical follow-up is NOT possible.
- The patient has large-area metallic implants or tattoos including much metal powder within hyperthermia field (not including metallic hemoclips with small area and few numbers).
- The patient has pacemakers, electrocardiograph, defibrillator implanted, or adhesive skin patches including conductive metal.
- The patients with ocular or cerebral disorders within hyperthermia field.
- Tumor invasion of great or large vessels exists, or patients with any existing complications that may pose risks to hyperthermia treatment.
- Patients who have difficulty with communication.
- Other patients who are considered to have a contraindication to hyperthermia treatment.
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|
|Shin Kong Wu Ho-Su Memorial Hospital||Recruiting|
|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|
|Responsible Party:||Shin Kong Wu Ho-Su Memorial Hospital|
|Other Study ID Numbers:||
|First Posted:||October 5, 2015 Key Record Dates|
|Last Update Posted:||July 28, 2020|
|Last Verified:||July 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
head and neck cancer
hyperthermia, Thermotron RF-8
Head and Neck Neoplasms
Neoplasms by Site
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries
Molecular Mechanisms of Pharmacological Action