Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors

June 8, 2015 updated by: Shin Kong Wu Ho-Su Memorial Hospital

A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11101
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of 20-85 years, with ECOG performance 0-2.
  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.
  3. 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.
  4. Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
  5. Measurable lesions by image examinations or endoscopy within 2 months.
  6. The distribution of the lesions of interest does NOT exceed 20cm range.
  7. 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:

  1. Re-irradiation of 50Gy/22fx is considered NOT tolerable.
  2. Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
  3. The patient is participating in other clinical trials.
  4. Future regular clinical follow-up is NOT possible.
  5. The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
  6. The patient has pacemakers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation; Hyperthermia; Chemotherapy
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.
Radiation: Radiation
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.
Other: 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
Drug: Cisplatin
30mg/m2
Drug: Taxotere
20mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 12 weeks
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.
up to 12 weeks
Late adverse events
Time Frame: up to 1 years
To estimate rates of late adverse events.
up to 1 years
Time to Disease Progression
Time Frame: up to 5 years
To estimate the local control rate, distant metastasis rate and progression-free rate for patients.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140101D (Other Identifier: ShinKongHospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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