The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease (RADIANT)
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|ClinicalTrials.gov Identifier: NCT04122469|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 29, 2019
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progressionhas become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years.
During the visits participants will complete quality of life questionnaires and will have standard of care imaging.
Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA
|Condition or disease||Intervention/treatment||Phase|
|Malignancy||Radiation: Stereotactic Body Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Stereo-tActic BoDy RadIotherApy iN Oligo-Progressive MalignanT Disease|
|Actual Study Start Date :||September 11, 2019|
|Estimated Primary Completion Date :||September 20, 2021|
|Estimated Study Completion Date :||September 20, 2023|
Radiation: Stereotactic Body Radiotherapy
A previous study found that in four of the five metastatic GI patients, SBRT increased the duration of effective systemic therapy with no significant additional toxicities. There have been small number of case reports in lung and renal cancers, which suggest the potential for improvement in progression free survival. The purpose of this study is to evaluate the safety, and efficacy of SBRT in this patient population
- Safety of SBRT in OP malignancies [ Time Frame: 24 month period ]To determine the safety of SBRT in OP malignancies over a 24-month follow-up period using CTCAE v5.0.
- Efficacy of SBRT in OP malignancies [ Time Frame: 24 month period ]To determine the efficacy of SBRT in OP malignancies over a 24-month follow-up period by evaluating progression-free survival. Radiographic local control of irradiated areas and local disease will also be used to determine efficacy by using Response Evaluation Criteria in Solid Tumors (RECIST).
- Feasibility of SBRT in OP malignancies [ Time Frame: 24 month period ]To determine the feasibility of SBRT in OP malignancies over a 24-month follow-up period using the a quality of life questionnaire (the EORTC QLQ-C30 questionnaire).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122469
|Contact: Aisling Barry, MD||4169464501 ext email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Aisling Barry, MD 416-946-4501 ext 2127 firstname.lastname@example.org|