Clinical trial · Interventional
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
A Phase II Clinical Trial Evaluating the Safety and Efficacy of Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Taiwan FDA asked for seperating this protocol into one disease site per protocol.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation; Hyperthermia; Chemotherapy
- 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.
- interventionNames
- Radiation: Radiation
- Other: Hyperthermia
- Drug: Cisplatin
- Drug: Taxotere
Primary outcomes (1)
- measure
- Tumor response rate
- timeFrame
- 12 weeks
- description
- To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available