Solid TumorsPhase 2NCT02120118
Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) in Treatment Failure Solid Tumors
A Phase 2 study testing Radiation, Hyperthermia and Cisplatin in people with Solid Tumors, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Radiation, Hyperthermia and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 20-85 years, with ECOG performance 0-2.
- 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.
- 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.
- Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
- Measurable lesions by image examinations or endoscopy within 2 months.
- The distribution of the lesions of interest does NOT exceed 20cm range.
- 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.
Who cannot join
- Re-irradiation of 50Gy/22fx is considered NOT tolerable.
- Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
- The patient is participating in other clinical trials.
- Future regular clinical follow-up is NOT possible.
- The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
- The patient has pacemakers.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Solid Tumors
- Keywords
- Treatment failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
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.
HyperthermiaOther
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
CisplatinDrug
30mg/m2
TaxotereDrug
20mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Radiation; Hyperthermia; Chemotherapy | Experimental | 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. Receives: Radiation: Radiation; Other: Hyperthermia; Drug: Cisplatin; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
To estimate the tumor response rate (complete response + partial response; CR + PR; according to RECIST criteria version 1.1).
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: up to 12 weeks
Late adverse events
To estimate rates of late adverse events.
Measured: up to 1 years
Time to Disease Progression
To estimate the local control rate, distant metastasis rate and progression-free rate for patients.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Taiwan FDA asked for seperating this protocol into one disease site per protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120118
- Sponsor's protocol ID
- 20140101D
- Other IDs
- 20140101D
- Status last verified
- Oct 2014
- First submitted
- 17 Mar 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02120118
- Acronym / sponsor ID
- 20140101D
- Conditions
- Solid Tumors
- Keywords
- Treatment failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Taiwan FDA asked for seperating this protocol into one disease site per protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation; Hyperthermia; Chemotherapy | Experimental | Radiation: Radiation, Other: Hyperthermia, Drug: Cisplatin, Drug: TaxoterePatients 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 20-85 years, with ECOG performance 0-2.
- 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.
- 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.
- Salvage radiotherapy is possible, and a total dose of 50Gy/22fx is considered tolerable.
- Measurable lesions by image examinations or endoscopy within 2 months.
Key exclusion criteria (6 listed)
- Re-irradiation of 50Gy/22fx is considered NOT tolerable.
- Future tumor response to treatment in this study is NOT possibly evaluated using image examinations or endoscopy.
- The patient is participating in other clinical trials.
- Future regular clinical follow-up is NOT possible.
- The patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation2Gy/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. | Radiation | Radiation; Hyperthermia; Chemotherapy |
| Hyperthermia42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times | Other | Radiation; Hyperthermia; Chemotherapy |
| Cisplatin30mg/m2 | Drug | Radiation; Hyperthermia; Chemotherapy |
| Taxotere20mg/m2 | Drug | Radiation; Hyperthermia; Chemotherapy |
Primary outcome
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).
3 secondary outcomes
Adverse events
Time frame: up to 12 weeks
Late adverse events
Time frame: up to 1 years
Time to Disease Progression
Time frame: up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation, Hyperthermia and Cisplatin in people with Solid Tumors, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.