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

Primary Purpose

Recurrent Head and Neck Cancer

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Radiation

Hyperthermia; Thermotron RF-8

Cisplatin

Taxotere

About this trial

This is an interventional treatment trial for Recurrent Head and Neck Cancer focused on measuring head and neck cancer, hyperthermia, Thermotron RF-8, radiotherapy

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperthermia

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Late adverse events

To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy)

Full Information

NCT ID

NCT02567383

First Posted

October 1, 2015

Last Updated

July 27, 2020

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02567383

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Head and Neck Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperthermia

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Hyperthermia; Thermotron RF-8

Intervention Description

40 minutes within 2hr after irradiation

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Taxotere

Intervention Description

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

Primary Outcome Measure Information:

Title

Tumor response rate

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.

Time Frame

12 Weeks

Secondary Outcome Measure Information:

Title

Adverse events

Description

Time Frame

Within 3 months

Title

Late adverse events

Description

To estimate rates of late adverse events (3 months from start of radiation combined with hyperthermia and chemotherapy)

Time Frame

After 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kwan-Hwa Chi, M.D.

Phone

886-2-28332211

Ext

2274

M006565@ms.skh.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Kai-Lin Yang, M.D.

Phone

886-2-28332211

Ext

2275

M011360@ms.skh.org.tw

Facility Information:

Facility Name

Shin Kong Wu Ho-Su Memorial Hospital

City

Taipei

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kwan-Hwa Chi, M.D.

Phone

886-2-28332211

Ext

2274

M006565@ms.skh.org.tw

First Name & Middle Initial & Last Name & Degree

Kai-Lin Yang, M.D.

Phone

886-2-28332211

Ext

2275

M011360@ms.skh.org.tw

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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