Back to resultsCombination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
Primary Purpose
Solid Tumors
Status
Withdrawn
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Radiation
Hyperthermia
Cisplatin
Taxotere
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumors focused on measuring Treatment failure
Eligibility Criteria
Inclusion Criteria:
- Age of 20-85 years, with ECOG performance 0-2.
- Treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any 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.
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 within hyperthermia field (not including metallic hemoclips with small area and few numbers).
- The patient has pacemakers.
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiation; Hyperthermia; Chemotherapy
Arm Description
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
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).
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.
Time to Disease Progression
To estimate the local control rate, distant metastasis rate and progression-free rate for patients.
Full Information
NCT ID
NCT02120118
First Posted
March 17, 2014
Last Updated
June 8, 2015
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02120118
Brief Title
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
Official Title
A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Taiwan FDA asked for seperating this protocol into one disease site per protocol.
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (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
Yes
5. Study Description
Brief Summary
The primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment failure solid tumors 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
The goal of this study is to conduct a phase II clinical trial evaluating the safety and efficacy of combination of low temperature (40-43℃ range) hyperthermia and concurrent chemoradiotherapy (CCRT) in treatment failure solid tumors. There are 3 reasons of conducting this clinical trial. Firstly, it has been demonstrated that hyperthermia can enhance the efficacy of chemotherapy, radiotherapy or chemoradiotherapy in various cancers, with acceptable safety profiles. Secondly, the salvage outcomes for treatment failure solid tumors were frustrated. Thermal enhancement ratio (TER) was observed when using hyperthermia combining radiotherapy or chemotherapy. This strategy should be investigated in its efficacy in treating those failing from previous standard treatment and maybe several times of salvage therapy. Thirdly, biologically reciprocal complementation between hyperthermia, chemotherapy and radiotherapy was observed. The reason may be complicated, including theories involving hypoxia, immunomodulation and reperfusion … etc. If the immunity microenvironment could be improved by addition of hyperthermia, an unexpected survival benefit as compared with the literature may be potentially demonstrated from this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors
Keywords
Treatment failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiation; Hyperthermia; Chemotherapy
Arm Type
Experimental
Arm Description
Patients will be treated with radiotherapy with 50Gy/22fx/6 weeks, plus hyperthermia 42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times. The regimen of concurrent chemotherapy will cisplatin 30mg/m2 and taxotere 20mg/m2 per week for 6 weekly cycles.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
2Gy/5fx/week for a subtotal of 40Gy/20fx/4 weeks, followed by reduced-field boost with 10Gy/2fx/2 weeks (5Gy once a week during 5th and 6th week), totalling 50Gy/22fx/6 weeks.
Intervention Type
Other
Intervention Name(s)
Hyperthermia
Intervention Description
42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
30mg/m2
Intervention Type
Drug
Intervention Name(s)
Taxotere
Intervention Description
20mg/m2
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
up to 12 weeks
Title
Late adverse events
Description
To estimate rates of late adverse events.
Time Frame
up to 1 years
Title
Time to Disease Progression
Description
To estimate the local control rate, distant metastasis rate and progression-free rate for patients.
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 20-85 years, with ECOG performance 0-2.
Treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any 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.
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 within hyperthermia field (not including metallic hemoclips with small area and few numbers).
The patient has pacemakers.
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
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