Recurrent Head and Neck Cancer Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Shin Kong Wu Ho-Su Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response rate | 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. | 12 Weeks | |
Secondary | Adverse events | 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. | Within 3 months | |
Secondary | Late adverse events | To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy) | After 3 months |
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