Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart

HDR brachytherapy of 19 Gy delivered in a single fraction

High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.

HDR 2 Fraction

High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

HDR 1 Fraction

Gerard Morton, MD

A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.

A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.

To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)

To determine changes in serum prostate-specific antigen (PSA) in both arms

To determine PSA failure and disease free survival rates in both study arms

To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale

To explore association between dosimetric parameters and toxicity/EPIC domain change

Sunnybrook Health Sciences Centre

Dr. Gerard Morton

Behaviors and Mental Disorders

Quality of Life

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

After completion of 46 Gy of external beam radiotherapy subjects will undergo a permanent seed radioactive implant to the prostate using iodine-125 seeds to deliver a dose of 110 Gy

Subjects in this arm will undergo an HDR implant to deliver 15 Gy to the prostate prior to commencing the external beam component of their treatment.

Juanita M Crook, MD

Optimal non surgical treatment of prostate cancer requires dose escalation which is frequently provided by adding a brachytherapy "boost" to a short course of external beam radiotherapy. The hypothesis in this randomized study is that a High Dose Rate (HDR) brachytherapy boost leads to equivalent or better Prostate Specific Antigen (PSA) recurrence-free survival when compared to a Low Dose Rate (LDR) brachytherapy boost and that it is associated with a more favorable toxicity profile and improved quality of life.

Men with intermediate or high risk prostate cancer who are technically suitable for prostate brachytherapy based on prostate size and voiding function and who are interested in this modality of treatment will be approached for randomization between either high dose rate (single 15 Gray) or low dose rate permanent seed implant (110 Gray) brachytherapy. Baseline International Prostate Symptom score, Quality of Life Assessment and International Index of Erectile Function will be recorded and then every 3 months for the first year and every 6 months to 3 years. Androgen deprivation treatment is allowed for 6 or 12 months.

Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy

IMPROVING QUALITY OF LIFE AFTER OPTIMAL RADIOTHERAPY FOR INTERMEDIATE AND HIGH RISK PROSTATE CANCER: A Randomized Comparison of HDR Versus LDR BRACHYTHERAPY BOOST

regular PSA monitoring every 6 months to 3 years and then annually to determine PSA recurrence free survival

Quality of life will be measured through validated instruments including International Prostate Symptom Score (IPSS), the International Index of Erectile Function ((IEF), and the urinary, bowel and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). IPSS has 7 questions related to voiding symptoms, each scored 0-5, with a higher score indicating worse symptoms. IIEF has 5 questions, each scored 0-5 with a higher score indicating better function. EPIC has several questions for each domain with an overall higher score associated with better QoL in that domain.

Quality of Life will be assessed to 5 years using the validated instruments International Prostate Symptom Score, International Index Erectile Function and EPIC

BC Cancer Foundation

British Columbia Cancer Agency

Symptoms and General Pathology

Recurrence

Disease Attributes

High-Dose-Rate brachytherapy, 2 fractions

High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion

High-Dose-Rate Brachytherapy

Christine Huggins

Hong Zhang, MD

Hong Zhang

The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on prostate cancer.

In this study the investigator would like to better understand the use of high-dose rate (HDR) brachytherapy to target only recurrent prostate cancer that can be seen by AXUMIN PET scan. The use of HDR brachytherapy for prostate cancer is not new, but it is a more recent advancement to use it to treat only what can be seen instead of the whole prostate.

A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

A Pilot Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

Rate of prostate-specific antigen (PSA) failure after focal salvage HDR in the setting of prostate only recurrence after primary non-surgical treatment, defined as a PSA rise of 2 ng/ml or more above the nadir at 6 months

Measured by adverse event severity and quantity

Measure of time from study enrollment until progression.

University of Rochester

Associate Professor - Department of Radiation Oncology (SMD)

Somatomedin B

Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.

Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:

Prostate :

* V100 \> 95%
* V150 30-35%
* V200 \< 15%
* D90 \> 90% (12,15Gy)

Bladder

• V75 \< 1cc

Rectum

• V75 \< 1cc

Urethra

V125 = 0cc D10 \< 120%

Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.

HDR brachytherapy monotherapy

The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.

Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer

Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer

Toxicity according to Expanded Prostate Index Composite (EPIC) questionnaires.

Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.

Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.

CSSS de Gatineau

Radiation Oncologist

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Uterine Cervical Neoplasms

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Esophageal Cancer

Biliary Tract Cancer

Radiation therapy given as HDR Brachytherapy.

Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.

HDR Brachytherapy

Debbie Nathan, R.N.

Deborah E Citrin, M.D.

Background:

* One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed.
* Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment.

Objectives:

* To evaluate the quality of the brachytherapy procedure at the National Institutes of Health s Radiation Oncology Branch.

Eligibility:

* Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment.

Design:

* In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history.
* Each treatment will take place in the Radiation Oncology Clinic.
* If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan.
* The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes.
* The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient.
* Patients will return to the Radiation Oncology Clinic for followup visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Followup evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, MRI, X-ray) that was done at baseline to evaluate the tumor response.

BACKGROUND:

* High dose rate brachytherapy (HDR) is a challenging technique utilized in many malignancies in order to deliver a high dose of radiation therapy to a tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue
* HDR therapy has been targeted to particular subsites as an integral part of either definitive management or palliation for malignancy-related symptoms.

OBJECTIVES:

* The primary objective is to determine the quality of high dose rate brachytherapy implants performed in the radiation oncology branch. An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met.
* To evaluate local control and late toxicity rates following brachytherapy at the NCI ROB
* To increase the flow of oncology participants requiring brachytherapy to the NCI ROB, as these participants lend themselves to special study and have unique educational value for the purpose of educating nurses, medical students, residents, physicists, clinical fellows, and physicians.

ELIGIBILITY:

-Participants with cancer who could potentially benefit from the use of high dose rate brachytherapy as a component of their treatment.

DESIGN:

* Participants will undergo appropriate work-up and clinical evaluation to determine if high-dose brachytherapy would be beneficial in either primary treatment or palliation of their disease. Participants will be treated with high-dose brachytherapy appropriately sequenced with other modalities in their treatment regimen. This treatment will be administered in accordance with standard radiation oncology practice and per the ABS (American Brachytherapy Society) guidelines.
* The participant s disease status and toxicity outcomes will be documented for a 12-month period at 3-months intervals.

A Study of Patients Receiving High-Dose Rate Brachytherapy

A Pilot Study of High Dose Rate Brachytherapy in The Radiation Oncology Branch

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

An implant will be adequate if 90% of the GTV receives 90% of the dose prescribed and 80% of the CTV receives 85% of the prescribed dose. An implant will be inadequate if the above dose limitations are not met.

National Cancer Institute (NCI)

Uterine Cervical Diseases

Antineoplastic Agents

Cisplatin

All patients receive IMRT with concurrent cisplatin 40 mg/m2

Patients in Phase III, Arm A receive 4-field box RT with concurrent cisplatin 40 mg/m2

Patients in Phase III, Arm B receive IMRT with concurrent cisplatin 40 mg/m2

45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks

Intensity Modulated Radiation Therapy (IMRT)

Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks

Loren Mell, MD

The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects.

Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute hematologic and gastrointestinal toxicity for cervical cancer patients treated with concurrent cisplatin.

Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer \[3-8\]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.

Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.

Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

To test whether IMRT will reduce the rate of acute grade ≥ 3 hematologic or clinically significant grade ≥ 2 gastrointestinal toxicity compared to conventional RT techniques for cervical cancer patients treated with concurrent cisplatin

To estimate and compare the probability of acute and late adverse events

To estimate and compare efficacy of cisplatin/IMRT in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre
Improving Quality of Life After Prostate Brachytherapy: a Comparison of HDR and LDR Brachytherapy	NCT01936883	Prostate Cancer	HDR LDR	45 Years - 80 Years	British Columbia Cancer Agency
A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence	NCT04645810	Prostate Cancer HDR	High-Dose-Rate ...	18 Years -	University of Rochester
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer	NCT02077335	Prostate Cancer	HDR brachythera...	18 Years -	CSSS de Gatineau
A Study of Patients Receiving High-Dose Rate Brachytherapy	NCT00924027	Cervical Cancer Endometrial Can... Esophageal Canc... Prostate Cancer Biliary Cancer	HDR Brachythera...	18 Years -	National Institutes of Health Clinical Center (CC)
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer	NCT02077335	Prostate Cancer	HDR brachythera...	18 Years -	CSSS de Gatineau
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer	NCT01554397	Cervical Cancer	Intensity Modul... Cisplatin	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for hdr

Every month we try and update this database with for hdr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hdr

Every month we try and update this database with for hdr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hdr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.