Cervical CancerNCT00911079
Pilot Study of a Catheter-based Ultrasound Hyperthermia System
A study testing Hyperthermia and HDR brachytherapy in people with Cervical Cancer and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Prostate Cancer
- What is being tested?
- Hyperthermia and HDR brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2009to 23 Jul 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:
- Cervical cancer Stage III or IV OR
- Prostate cancer (with rising prostate specific antigen after prior local therapy)
- Age >=18 years
- Eligible for brachytherapy as determined per clinical standard of care.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Who cannot join
- Patients who are not candidates for HDR brachytherapy
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143-1708
About this study
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.
Read the detailed description
OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.
After completion of study therapy, patients are followed at 1 and 3 months.
- Conditions
- Cervical Cancer, Prostate Cancer
- Being tested
- Hyperthermia, HDR brachytherapy
- Keywords
- Stage III, IV cervical cancer, Rising prostate specific antigen (PSA) after local therapy
- Medical subject headings
- Uterine Cervical Neoplasms, Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaProcedure or surgery
Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy)
HDR brachytherapyRadiation
Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia with HDR brachytherapy | Experimental | Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session Receives: Procedure: Hyperthermia; Radiation: HDR brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-related toxicities by treatment type
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
Measured: Up to 3 months
Frequency of treatment-related toxicities by accrual plan
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
Measured: Up to 3 months
Proportion of patients treated according to the specified temperature and timing criteria.
The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions
Measured: Up to 4 weeks
Secondary outcomes (5)
Average maximum prostate temperature (Tmax)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Measured: Up to 4 weeks
Minimum temperature (Tmin)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Measured: Up to 4 weeks
Median temperature (T50)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Measured: Up to 4 weeks
Number of times temperature exceeded by 90% of the measured temperature points (T90)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Measured: Up to 4 weeks
Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)
Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study start18 Dec 2009
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, I-Chow Hsu, University of California, San Francisco
- Investigators
- I-Chow J. Hsu, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911079
- Sponsor's protocol ID
- CDR0000643085
- Other IDs
- 08992, 5R01CA122276
- Status last verified
- Jun 2021
- First submitted
- 29 May 2009
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Catheter-based Ultrasound Hyperthermia System
- ClinicalTrials.gov ID
- NCT00911079
- Acronym / sponsor ID
- CDR0000643085
- Conditions
- Cervical Cancer, Prostate Cancer
- Keywords
- Stage III, IV cervical cancer, Rising prostate specific antigen (PSA) after local therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Dec 2009 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 1 Jun 2009 (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.
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.
PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with Stage III/IV cancer of the cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local therapy.
Detailed description
OUTLINE: Patients undergo standard high-dose rate (HDR) brachytherapy. Approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. Treatment with HDR brachytherapy and hyperthermia therapy repeats within 1-3 weeks. Patients may then undergo 2 additional standard HDR brachytherapy sessions.
After completion of study therapy, patients are followed at 1 and 3 months.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia with HDR brachytherapy | Experimental | Procedure: Hyperthermia, Radiation: HDR brachytherapyHyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:
- Age >=18 years
- Eligible for brachytherapy as determined per clinical standard of care.
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Key exclusion criteria (2 listed)
- Patients who are not candidates for HDR brachytherapy
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator
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 |
|---|---|---|
| HyperthermiaSingle course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy) | Procedure or surgery | Hyperthermia with HDR brachytherapy |
| HDR brachytherapyCompletion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants | Radiation | Hyperthermia with HDR brachytherapy |
Primary outcome
Frequency of treatment-related toxicities by treatment type
Time frame: Up to 3 months
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 and presented separately for the first and second hyperthermia treatments.
Frequency of treatment-related toxicities by accrual plan
Time frame: Up to 3 months
All patients treated with at least one hyperthermia session will be included in the safety analysis. The frequency by grade for all treatment-related adverse events will be tabulated by type as classified in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3 presented for the 2 subsets of patients corresponding to the plan for accrual: the first 3 patients with gynecologic cancer, then the final 9 patients with gynecologic cancer; and the first 3 patients with prostate cancer, then the final 9 patients with prostate cancer
Proportion of patients treated according to the specified temperature and timing criteria.
Time frame: Up to 4 weeks
The feasibility of administering hyperthermia to patients receiving standard brachytherapy will be summarized by the proportion of patients completing the treatment as planned. The proportion and 95% confidence interval will be calculated for each of the two hyperthermia sessions
5 secondary outcomes
Average maximum prostate temperature (Tmax)
Time frame: Up to 4 weeks
Minimum temperature (Tmin)
Time frame: Up to 4 weeks
Median temperature (T50)
Time frame: Up to 4 weeks
Number of times temperature exceeded by 90% of the measured temperature points (T90)
Time frame: Up to 4 weeks
Cumulative Equivalent Minutes at 43 degree celsius (ºC) for 90% of the measured points (CEM43T90)
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
I-Chow J. Hsu, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia and HDR brachytherapy in people with Cervical Cancer and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Jul 2021. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Low Accrual). Results are not available in the source record.
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?
Frequency of treatment-related toxicities by treatment type (time frame: Up to 3 months). The study lists 3 primary outcomes in all. 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 7 Jul 2021.