Clinical trial · Interventional
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
NCT02567383CI-TRIAL-00046213unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperthermia
- description
- Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere
- interventionNames
- Radiation: Radiation
- Device: Hyperthermia; Thermotron RF-8
- Drug: Cisplatin
- Drug: Taxotere
Primary outcomes (1)
- measure
- Tumor response rate
- timeFrame
- 12 Weeks
- description
- 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 outcomes (2)
- measure
- Adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYang KL, Chi MS, Hao CY, Ko HL, Huang YY, Wu RH, Lai HC, Lin YC, Hao SP, Chi KH. Phase II clinical trial assessing the addition of hyperthermia to salvage concurrent chemoradiotherapy for unresectable recurrent head and neck cancer in previously irradiated patients. Radiat Oncol. 2025 Feb 8;20(1):21. doi: 10.1186/s13014-025-02585-z. PMID 39920700