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

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ClinicalTrials.gov Identifier: NCT02567383
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Recurrent Head and Neck Cancer Radiation: Radiation Device: Hyperthermia; Thermotron RF-8 Drug: Cisplatin Drug: Taxotere Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperthermia
Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
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   
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital

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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT02567383     History of Changes
Other Study ID Numbers: 20150205D
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
head and neck cancer
hyperthermia, Thermotron RF-8
radiotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Fever
Neoplasms by Site
Neoplasms
Body Temperature Changes
Signs and Symptoms
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action