Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Vulvar Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Genital Neoplasms, Female

Urogenital Neoplasms

Vulvar Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms

DaRT seeds

Liron Dimnik

Aviya Hoida

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva.

This is an prospective Open label, single arm, multi center, interventional study treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva .The study objectives are to collect data on the Feasibility and Safety of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to evaluate the feasibility and safety of the Alpha DaRT sources for the treatment of vulva SCC. Feasibility will be determined according to the rate of successful placement of Alpha DaRT . Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.

The Secondary endpoint of the study will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva

Feasibility will be determined according to the rate of successful placement of Alpha DaRT

Safety will be determined according to the overall incidence of device related AEs and SAE's graded according to CTCAE v5.0 criteria.

The study's secondary objective will be to evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

Alpha Tau Medical LTD.

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Standard dose Adaptive tumour focused radiotherapy (SART)

Dose escalated Adaptive tumour boost radiotherapy (DART)

One RT plan with whole bladder treated to standard dose.

WBRT

Three plans (small, medium \& large) generated with the standard dose of RT focused on the tumour, sparing the normal bladder from full dose radiation. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.

SART

Three plans (small, medium \& large) generated with a higher dose than standard focused on the tumour and the remainder of the bladder treated to the same dose as in the SART group. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.

DART

Robert Huddart

Bladder cancer is the seventh most common cancer in the UK, with 10,399 new cases diagnosed in 2011. In a quarter of these cases the cancer has infiltrated the muscular wall of the bladder (muscle invasive) and is life threatening. This type of bladder cancer is usually treated either with surgical removal of the bladder, or daily radiotherapy treatment (high strength xrays which kill cells), given every day for 4 or 7 weeks. RAIDER will investigate methods which have the potential to improve how well this radiotherapy works.

RAIDER is based on a study of novel radiotherapy techniques which was conducted at a single UK NHS Trust. Bladder radiotherapy is normally delivered using a single plan throughout treatment and treats the whole bladder with the same radiotherapy dose. In adaptive radiotherapy the delivery plan is chosen from 3 possible plans. In cancer (tumour) focused radiotherapy, the highest dose of the radiotherapy is aimed at the tumour within the bladder.

In RAIDER, at least 240 participants with muscle invasive bladder cancer will be in one of 3 treatment groups:

1. standard whole bladder radiotherapy
2. standard dose tumour focused adaptive radiotherapy
3. dose escalated tumour boost adaptive radiotherapy

Participants will visit the hospital 4 weeks, 3, 6, 9, 12, 18 and 24 months after radiotherapy and annually thereafter to check whether the cancer has returned and to receive treatment for any symptoms they may be experiencing.

RAIDER aims to confirm in a multicentre setting that novel techniques allow a higher radiotherapy dose than standard to be reliably targeted at the tumour within the bladder and to check that the long term side effects of the treatment are acceptable. If this is the case, results of RAIDER will be used to develop a study to establish whether dose escalated radiotherapy is better at treating bladder cancer than standard dose.

RAIDER has a two stage design. Stage 1 will establish the feasibility of delivering DART in a multi-centre setting, and stage 2 will establish the toxicity of DART. 72 patients will be recruited in stage 1, with at least an additional 168 patients in stage 2 (sufficient to recruit 57 evaluable participants to the DART group in each fractionation cohort).

Both fractionation regimens in standard use in UK are included - 32f and 20f. Participants will be permitted to receive concomitant chemotherapy. Primary endpoints will be assessed in each fractionation cohort separately with the flexibility to drop either a fractionation cohort or an experimental treatment group (on advice of Independent Data Monitoring Committee) following completion of stage 1.

Study of Tumour Focused Radiotherapy for Bladder Cancer

A Randomised Phase II Trial of Adaptive Image Guided Standard or Dose Escalated Tumour Boost Radiotherapy in the Treatment of Transitional Cell Carcinoma of the Bladder

Primary outcome of stage 1 of study, predefined radiotherapy dose constraints for bladder, bowel and rectum met for medium plan in DART group.

Primary outcome of stage 2 of study, late CTC toxicity grade 3 or higher.

Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire

excerpt of the EORTC QLQ-BLM30 questionnaire

Assessment of Late Effects of RadioTherapy - Bowel (ALERT-B) questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.
Study of Tumour Focused Radiotherapy for Bladder Cancer	NCT02447549	Bladder Cancer	WBRT SART DART	16 Years -	Institute of Cancer Research, United Kingdom
Study of Tumour Focused Radiotherapy for Bladder Cancer	NCT02447549	Bladder Cancer	WBRT SART DART	16 Years -	Institute of Cancer Research, United Kingdom
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.
Alpha Radiation Emitters Device for the Treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva (DaRT).	NCT06202339	Carcinoma of th... Recurrent Carci...	DaRT seeds	18 Years - 120 Years	Alpha Tau Medical LTD.

Spots Global Cancer Trial Database for dart

Every month we try and update this database with for dart 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 dart

Every month we try and update this database with for dart 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 dart 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.