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Effectiveness of palliative re-irradiation with superficial hyperthermia in patients with unresectable recurrent squamous cell carcinoma of the head and neck.

Effectiveness of palliative re-irradiation with superficial hyperthermia in patients with unresectable recurrent squamous cell carcinoma of the head and neck. : descriptive analytic studies

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250522005
Enrollment
20
Registered
2025-05-22
Start date
2025-05-14
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse effects will be evaluated using physical examination according to the RTOG toxicity score, specifically for radiation-induced dermatitis. Pain will be assessed using a visual analog scale (VAS), and quality of life will be assessed using the EQ-5D-5L Thai version questionnaire. dermatitis, hyperthermia, re-irradiation

Interventions

CT simulation of the head and neck region with 3 mm slice thickness (from vertex to carina) will be performed. Patients will be immobilized using a thermoplastic mask. Radiotherapy will be administere
Hyperthermia

Sponsors

ABEX global healthcare,Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 to 70 years. 2. Patients with recurrent squamous cell carcinoma of the head and neck, specifically cervical lymph node recurrence, after completion of standard treatment for head and neck cancer, or patients with persistent disease at the cervical region for at least 3 months after standard treatment, or newly diagnosed unresectable or chemotherapy-resistant recurrent tumors. 3.Diagnosis confirmed by radiologic imaging and/or histopathological confirmation of squamous cell carcinoma. 4. The recurrent tumor or lymph node must not exceed 10 cm in maximum diameter, and the depth from the skin surface including skin thickness must not exceed 4 cm. 5. Eastern Cooperative Oncology Group (ECOG) performance status less than 3.

Exclusion criteria

Exclusion criteria: 1. Patients with recurrent squamous cell carcinoma of the head and neck who, in the physician judgment, have the potential for curative treatment via surgery, radiotherapy, and/or chemotherapy. 2. Estimated life expectancy of less than 4 months. 3. Presence of visceral crisis, such as lymphangitic carcinomatosis, extensive liver metastases, symptomatic lung metastases, or rapidly progressive metastases. 4. Pregnant or breastfeeding women. 5. History of grade 2 or more skin toxicity from previous radiation or chemotherapy. 6.Patients with immunodeficiency, dermatologic disorders, autoimmune diseases, or conditions with a high risk of radiation dermatitis. 7. Patients receiving alternative or non-conventional cancer treatments.

Design outcomes

Primary

MeasureTime frame
volume of gross tumor at 8 weeks after end of the intervention volumetric from Computerize tomography

Secondary

MeasureTime frame
acute side effect skin toxicities during intervention RTOG radiation dermatitis grade,quality of life during intervention Patient quality of life assessed by the EQ-5D-5L Thai version questionnaire.

Countries

Thailand

Contacts

Public ContactPanlop Malasri

Udonthani cancer hospital

Panlopmls@hotmail.com0821164144

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026