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

NCT02567383 | Unknown Phase 2

• 1 other identifier: 20150205D
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Head and Neck Cancer

Keywords

head and neck cancer; hyperthermia, Thermotron RF-8; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse events

  Within 3 months

• Late adverse events

  After 3 months

Study Arms (1)

Hyperthermia

EXPERIMENTAL

Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere

Radiation: Radiation; Device: Hyperthermia; Thermotron RF-8; Drug: Cisplatin; Drug: Taxotere

Interventions

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

Hyperthermia

Hyperthermia; Thermotron RF-8 DEVICE

40 minutes within 2hr after irradiation

Hyperthermia

Cisplatin DRUG

20mg/m2 per week for 6 weekly cycles before radiotherapy

Hyperthermia

Taxotere DRUG

10-12mg/m2 per week for 6 weekly cycles before radiotherapy

Hyperthermia

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20-85 years, with ECOG performance 0-2.
• Treatment failure head and neck cancer, with histologically or clinically confirmed recurrence or progression after previous treatment of radiotherapy with combinations.
• 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.
• Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
• Measurable lesions by image examinations or endoscopy within 2 months.
• The distribution of the lesions of interest does NOT exceed 20cm range.
• 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.
• There is NO other effective treatment option according to the evaluation of physicians.

You may not qualify if:

• Re-irradiation of 50Gy/22fx is considered NOT tolerable.
• Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
• The patient is participating in other clinical trials.
• Future regular clinical follow-up is NOT possible.
• 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).
• The patient has pacemakers, electrocardiograph, defibrillator implanted, or adhesive skin patches including conductive metal.
• The patients with ocular or cerebral disorders within hyperthermia field.
• Tumor invasion of great or large vessels exists, or patients with any existing complications that may pose risks to hyperthermia treatment.
• Patients who have difficulty with communication.
• Other patients who are considered to have a contraindication to hyperthermia treatment.

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Yang 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 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Hyperthermia

Interventions

Radiation; Diathermy; Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Phenomena; Hyperthermia, Induced; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Kwan-Hwa Chi, M.D.

CONTACT

886-2-28332211; M006565@ms.skh.org.tw

Kai-Lin Yang, M.D.

CONTACT

886-2-28332211; M011360@ms.skh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 5, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

TW (1)