Overview

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

Status:
Withdrawn
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shin Kong Wu Ho-Su Memorial Hospital
Treatments:
Cisplatin
Docetaxel
Criteria
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.