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Trial record 9 of 1594 for:    hyperthermia | Recruiting, Active, not recruiting, Enrolling by invitation Studies

Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567383
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 5, 2015
Last Update Posted Date July 28, 2020
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
Official Title  ICMJE A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
Brief Summary Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with CCRT on recurrent head and neck cancer are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.
Detailed Description Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia for 40 minutes within 2hr after irradiation, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will be cisplatin 20mg/m2 and taxotere 10-12mg/m2 per week for 6 weekly cycles on the day before radiotherapy and hyperthermia treatment. The two chemotherapy agents will be given in only one day every week, according to the weekly dose. According to Gehan two-stage design, provided the estimated tumor response rate using this regimen is about 40% and objective tumor response is observed in ≥1 of the first 6 patients enrolled, α<0.05 will be achieved indicating a preliminary efficacy. Then the Gehan second stage will be started. With a set of 5% precision and an assumption of 10% dropout rate, 39 additional patients will be enrolled in the Gehan second stage depending on the actual number with tumor response in the Gehan first stage (totaling 45 patients when counting the first 6 in the Gehan first stage). The tumor response, adverse effects and various survival curves will be analyzed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Head and Neck Cancer
Intervention  ICMJE
  • Radiation: Radiation
    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
  • Drug: Cisplatin
    20mg/m2 per week for 6 weekly cycles before radiotherapy
  • Drug: Taxotere
    10-12mg/m2 per week for 6 weekly cycles before radiotherapy
Study Arms  ICMJE Experimental: Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
Interventions:
  • Radiation: Radiation
  • Device: Hyperthermia; Thermotron RF-8
  • Drug: Cisplatin
  • Drug: Taxotere
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 20-85 years, with ECOG performance 0-2.
  2. Treatment failure head and neck cancer, with histologically or clinically confirmed recurrence or progression after previous treatment of radiotherapy with combinations.
  3. 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.
  4. Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
  5. Measurable lesions by image examinations or endoscopy within 2 months.
  6. The distribution of the lesions of interest does NOT exceed 20cm range.
  7. 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.
  8. There is NO other effective treatment option according to the evaluation of physicians.

Exclusion Criteria:

  1. Re-irradiation of 50Gy/22fx is considered NOT tolerable.
  2. Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
  3. The patient is participating in other clinical trials.
  4. Future regular clinical follow-up is NOT possible.
  5. 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).
  6. The patient has pacemakers, electrocardiograph, defibrillator implanted, or adhesive skin patches including conductive metal.
  7. The patients with ocular or cerebral disorders within hyperthermia field.
  8. Tumor invasion of great or large vessels exists, or patients with any existing complications that may pose risks to hyperthermia treatment.
  9. Patients who have difficulty with communication.
  10. Other patients who are considered to have a contraindication to hyperthermia treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02567383
Other Study ID Numbers  ICMJE 20150205D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shin Kong Wu Ho-Su Memorial Hospital
Study Sponsor  ICMJE Shin Kong Wu Ho-Su Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shin Kong Wu Ho-Su Memorial Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP