Recurrent Head and Neck CancerPhase 2NCT02567383
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
A Phase 2 study testing Radiation, Hyperthermia; Thermotron RF-8 and Cisplatin in people with Recurrent Head and Neck Cancer, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Recurrent Head and Neck Cancer
- What is being tested?
- Radiation, Hyperthermia; Thermotron RF-8 and Cisplatin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Kwan-Hwa Chi, M.D., 886-2-28332211 ext. 2274, M006565@ms.skh.org.tw
Kai-Lin Yang, M.D., 886-2-28332211 ext. 2275, M011360@ms.skh.org.tw
About this study
Official title: A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
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.
Read the detailed description
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.
- Conditions
- Recurrent Head and Neck Cancer
- Keywords
- head and neck cancer, hyperthermia, Thermotron RF-8, radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
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; Thermotron RF-8Device
40 minutes within 2hr after irradiation
CisplatinDrug
20mg/m2 per week for 6 weekly cycles before radiotherapy
TaxotereDrug
10-12mg/m2 per week for 6 weekly cycles before radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia | Experimental | Hyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere Receives: Radiation: Radiation; Device: Hyperthermia; Thermotron RF-8; Drug: Cisplatin; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (2)
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.
Measured: Within 3 months
Late adverse events
To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy)
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567383
- Sponsor's protocol ID
- 20150205D
- Status last verified
- Jul 2020
- First submitted
- 1 Oct 2015
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39920700
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02567383
- Acronym / sponsor ID
- 20150205D
- Conditions
- Recurrent Head and Neck Cancer
- Keywords
- head and neck cancer, hyperthermia, Thermotron RF-8, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia | Experimental | Radiation: Radiation, Device: Hyperthermia; Thermotron RF-8, Drug: Cisplatin, Drug: TaxotereHyperthermia; Thermotron RF-8, radiation, Cisplatin and Taxotere |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation5-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 | Radiation | Hyperthermia |
| Hyperthermia; Thermotron RF-840 minutes within 2hr after irradiation | Device | Hyperthermia |
| Cisplatin20mg/m2 per week for 6 weekly cycles before radiotherapy | Drug | Hyperthermia |
| Taxotere10-12mg/m2 per week for 6 weekly cycles before radiotherapy | Drug | Hyperthermia |
Primary outcome
Tumor response rate
Time frame: 12 Weeks
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.
2 secondary outcomes
Adverse events
Time frame: Within 3 months
Late adverse events
Time frame: After 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 39920700Yang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation, Hyperthermia; Thermotron RF-8 and Cisplatin in people with Recurrent Head and Neck Cancer, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwan-Hwa Chi, M.D. (886-2-28332211 ext. 2274, M006565@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.