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| ID | Type | Description | Link |
|---|---|---|---|
| 08992 | Other Identifier | University of California, San Francisco | |
| 5R01CA122276 | U.S. NIH Grant/Contract | View source |
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Low Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthermia with HDR brachytherapy | Experimental | Hyperthermia will be delivered within approximately 2 hours of (HDR) brachytherapy associated with the implant session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermia | Procedure | Single course of Catheter-based Ultrasound Hyperthermia (within approximately 2 hours of a Standard-of-care High Dose Rate (HDR) Brachytherapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Average maximum prostate temperature (Tmax) | Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment | Up to 4 weeks |
| Minimum temperature (Tmin) |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I-Chow J. Hsu, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-1708 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2019 | Jul 23, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011471 | Prostatic Neoplasms |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| HDR brachytherapy | Radiation | Completion of standard-of-care high dose rate (HDR) Brachytherapy treatments (radiation fractions) using Session #1 catheter implants |
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Attainable temperature and thermal dose distributions will be summarized using descriptive statistics and presented separately for each hyperthermia treatment
| 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 | 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 | 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 | Up to 4 weeks |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |