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

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Treatments: Cisplatin; Docetaxel

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.