Solid Tumors Clinical Trial
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
Verified date | October 2014 |
Source | Shin Kong Wu Ho-Su Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 85 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Shin Kong Wu Ho-Su Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Shin Kong Wu Ho-Su Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor response rate | To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1). | 12 weeks | No |
Secondary | 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. | up to 12 weeks | Yes |
Secondary | Late adverse events | To estimate rates of late adverse events. | up to 1 years | Yes |
Secondary | Time to Disease Progression | To estimate the local control rate, distant metastasis rate and progression-free rate for patients. | up to 5 years | No |
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