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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.
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia for 40 minutes within 2hr after irradiation, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will be cisplatin 20mg/m2 and taxotere 10-12mg/m2 per week for 6 weekly cycles on the day before radiotherapy and hyperthermia treatment. The two chemotherapy agents will be given in only one day every week, according to the weekly dose. According to Gehan two-stage design, provided the estimated tumor response rate using this regimen is about 40% and objective tumor response is observed in ≥1 of the first 6 patients enrolled, α<0.05 will be achieved indicating a preliminary efficacy. Then the Gehan second stage will be started. With a set of 5% precision and an assumption of 10% dropout rate, 39 additional patients will be enrolled in the Gehan second stage depending on the actual number with tumor response in the Gehan first stage (totaling 45 patients when counting the first 6 in the Gehan first stage). The tumor response, adverse effects and various survival curves will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthermia | Experimental | Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Late adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwan-Hwa Chi, M.D. | Contact | 886-2-28332211 | 2274 | M006565@ms.skh.org.tw |
| Kai-Lin Yang, M.D. | Contact | 886-2-28332211 | 2275 | M011360@ms.skh.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39920700 | Derived | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D003972 | Diathermy |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
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| Hyperthermia; Thermotron RF-8 | Device | 40 minutes within 2hr after irradiation |
|
| Cisplatin | Drug | 20mg/m2 per week for 6 weekly cycles before radiotherapy |
|
| Taxotere | Drug | 10-12mg/m2 per week for 6 weekly cycles before radiotherapy |
|
To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy) |
| After 3 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D007287 |
| Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |