Clinical trial NCT02120118: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Solid Tumors
Keywords: Treatment failure
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Tumor response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: up to 12 weeks
measure: Late adverse events
timeFrame: up to 1 years
measure: Time to Disease Progression
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References: