Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Rare Diseases

Lung Neoplasms

Carcinoma

Neoplasm Metastasis

Breast Neoplasms

Recurrence

Melanoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Second Primary

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

* MRI will be performed prior to radiation is administered
* A hippocampal sparing approach will be used when possible
* Dose will be 30 Gy in 10 fractions

* MRI will be performed prior to radiation is administered
* Radiation will be given in 1-5 fractions (dose depends on the size of the tumor that will be treated)

Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.

Whole brain radiation

Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.

Stereotactic radiation (SRS)

Ayal Aizer, MD

Ivy Ricca, BA

Ayal Aizer, MD MHS

This research study is studying two different types of radiation as treatment for brain metastases (tumors in the brain that spread from a cancer that originated elsewhere in the body)

This research study is a Phase III clinical trial. Phase III clinical trials examine the safety and effectiveness of a treatment, often comparing it to another known treatment. In this case, the investigators are specifically looking at differences between two forms of radiation treatment in terms of subsequent quality of life.

In this research study, the investigators are comparing stereotactic (focused, pinpoint) radiation (in which each tumor is narrowly targeted) against whole brain radiation (radiation targeting the entire brain) in the treatment of brain metastases. Currently whole brain radiation is the standard option for patients with 5-20 brain metastases. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, recently published studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. It also yields better quality of life in this population. It remains unknown whether stereotactic radiation improves quality of life in patients with 5-20 brain metastases relative to whole brain radiation. In this study, the investigators seek to determine which of the two methods of study treatment results in a better subsequent quality of life for patients with 5-20 brain metastases.

Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial

Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation (SRS) in Patients With 5-20 Brain Metastases: A Phase III, Randomized Clinical Trial

Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT)

Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus systemic)

Radiographic assessment of first appearance of new brain metastases

Radiographic assessment of first local recurrence in the 5-20 brain metastases that were initially treated with radiation

Radiographic assessment of first appearance of radiation necrosis

Radiographic assessment of first appearance of leptomeningeal disease

Clinical assessment of first use of neurosurgical resection as salvage therapy

Clinical assessment of first use of salvage brain-directed radiation

Clinical assessment of first post-treatment seizure as assessed during routine study visits and via medical record review

Questionnaire - Karnofsky performance status

Brigham and Women's Hospital

Dana-Farber Cancer Institute

Principal Investigator

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Disease Attributes

SBRT: 5 x 6.75 Gy (every other day) to the total dose of 33.75 Gy

Salvage SBRT will be performed in three subgroups of patients with local recurrence:

Group A - after conventionally fractionated definitive radiotherapy; Group B - after prostatectomy and postoperative radiotherapy; Group C - after ultrahypofractionated definitive SBRT

Target volumes:

GTV- tumour visible on MRI and PET-CT; CTV- 1-3 mm margin around GTV PTV- 3 mm around CTV\*

\*- in cases in which very high accuracy and reproducibility of SBRT are ensured, and the margin overlaps the rectum and/or bladder, it is possible to reduce the margin from these organs to 1 mm.

Dose constrains:

The criteria for limiting the dose in nearby organs are not well-defined for repeated irradiation - the following doses should be aimed:

* Maximum rectal dose ≤103% of the prescribed dose (optimal ≤100%)
* Maximum bladder dose ≤105% of the prescribed dose (optimal ≤103%)

Dose-volume constrains:

Rectum:

• D30% \<15Gy

Bladder:

• D30% \< 15 Gy

Stereotactic Body Radiotherapy

Wojciech Majewski, MD, PhD

Aleksandra Napieralska, MD, PhD

The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy.

The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control.

Secondary endpoints include: Biochemical Response, Metastases-Free Survival, Relapse-Free Survial, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25).

The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B).

The study group is planned to include 60 patients.

The diagnosis of local recurrence after radiotherapy in patients with prostate cancer is a serious clinical problem. Interventional salvage treatment in the previously irradiated area is difficult with safety issues of special concern. According to the MASTER meta-analysis the effectiveness of various local salvage methods turned out to be comparable in patients with local recurrence after definitive radiotherapy. Stereotactic radiotherapy (SBRT) had the best toxicity profile, so this non-invasive treatment may be a suitable alternative to other methods. A particular problem is local recurrences after post-prostatectomy radiotherapy. The data on SBRT in such setting are even more scarce than in the case of relapses after definitive radiotherapy. Still, they show a low percentage of serious adverse events of grade ≥3 and good treatment tolerance.

Considering the own experience with re-irradiation of patients with prostate cancer, it was decided that re-irradiation should be carried out in the form of focal SBRT. With the objective of enhancing the safety and quality of salvage re-irradiation, and a comprehensive evaluation of the efficacy of this treatment it was determined that it should be implemented as a prospective phase II study- PROSTARE (PROstate cancer STereotActic Reirradiation).

The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in patients with local recurrence after conventionally fractionated definitive radiotherapy (Group A), ultrahypofractionated definitive SBRT (Group C), or after prostatectomy and postoperative radiotherapy (Group B).

The study will be conducted as a single-centre study. The evaluation of the safety and effectiveness of such treatment could help develop qualification criteria for repeated irradiation. As a consequence, this should allow for the implementation of this form of treatment into radiotherapy protocols and then, in a controlled and safe way, into clinical practice.

The total sample size will comprise 60 patients. The expected recruitment period is 6 years (10 patients per year).

Requirements for reirradiation with SBRT:

1. Both PET-PSMA and MR of the prostate or prostate bed are required in patients with recurrence after definitive radiotherapy or surgery followed by radiotherapy
2. Fiducial implantation is not routinely required
3. Empty rectum and empty/partially empty bladder (improved reproducibility)\* during treatment planning and during each fraction of stereotactic radiotherapy
4. Treatment with a linear accelerator is preferred
5. CBCT must be performed before each fraction of SBRT with verification for tumour location (GTV)\*\*
6. Focal radiotherapy, i.e., irradiation of only the visible tumour with an appropriate margin
7. Hormonal treatment is not routinely recommended (according to the ESTRO ACROP consensus) - up to the decision of the attending physician

   * Principles of preparation with laxatives - Bisacodyl is advocated 4-5 hours before SBRT. If the diameter of the rectum on the CT for treatment planning exceeds 4 cm in diameter, the procedure should be repeated after appropriate preparation of the patient.

     * If stereotactic radiotherapy is conducted on the CyberKnife - KV imaging and Tracking verification are required; additionally an assessment of bladder filling in ultrasonography should be performed

Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

Phase II Study - Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy - PROSTARE (PROstate Cancer STereotActic REirradiation) Trial

Assessment of early and late radiation toxicity: Grade ≥ 2 and ≥ 3 radiation-induced bladder/urethral (GU) and bowel/rectal (GI) adverse events toxicity or other, according to CTCAE criteria

Biochemical Control will be defined as observations without biochemical recurrence defined as PSA concentration:

1. \>2 ng/mL above the nadir (according to Phoenix) for groups A and C
2. \>0.2 ng/ml (according to AUA) for group B

Decrease in PSA level below baseline (pre-SBRT)

Metastases-Free Survival is the time interval between SBRT and ocurrence of distant metastases or death irrespective of the cause

Relapse-Free Survival is the time interval between SBRT and ocurrence of clinical relapse: local recurrence, regional or distant metastases, start of hormonal therapy, or death irrespective of the cause

Overall Survival is the time interval between SBRT and patient death irrespective of the cause

Evaluation of EORTC QLQ-C30 and PR-25 questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hippocampal Sparing Whole Brain Radiation Versus Stereotactic Radiation in Patients With 5-20 Brain Metastases: A Phase III, Randomized Trial	NCT03075072	Brain Metastase...	Whole brain rad... Stereotactic ra...	18 Years - 80 Years	Dana-Farber Cancer Institute
Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy	NCT06201078	Local Recurrenc... Radiotherapy	Stereotactic Bo...	18 Years - 80 Years	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for salvage

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

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