A Phase I Evaluating Integration of HypofractionatedStudy Renal Ablative Radiotherapy
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|ClinicalTrials.gov Identifier: NCT02264548|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2014
Last Update Posted : August 15, 2019
- evaluate the safety and toxicity profile of renal radio-ablation in the setting of metastatic renal cell carcinoma.
- to assess renal function post radio-ablation
- Primary and metastatic tumour response to radio-ablation
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Radiation: Radio-Ablation||Phase 1|
A dose limiting toxicity (DLT) will be defined as any grade 3, 4 or 5 toxicity event that is considered to be definitely, probably or possibility related to the protocol radiation therapy. Patients that cannot complete protocol therapy due to acute radiation side-effects will also be considered to be a DLT. The general (non-exhausive) list of organ based toxicity that could be related to this type of radiation therapy include toxicity to the liver, kidney, bowel, spinal cord, and pancreas. Side-effects that are exclusively due to TKI targeted therapy are not considered to be DLT in this protocol.
Three patients will be recruited for the first cohort of the trial. These patients will have the PTV prescribed a dose of 25 Gray to be given in 5 daily fractions over a period of one week (first treatment to start on a Wednesday or Thursday, with planned treatment on successive business days). All therapy should be delivered within 10 business days including any treatment breaks for acute toxicity. After 3 patients have been seen at the 4 week follow up visit, CTCAE version three will be noted. If precisely 1 patient has a DLT, then an additional 3 patients will be recruited to the same cohort and given the same treatment. If no patient has DLT, then a new cohort of 3 patients will be treated to an increased dose of 30 Gray in 5 fractions. Similar criteria will dictate whether the trial ends, or continues with the next cohort being treated to a dose of 35 Gray in 5 daily fractions. There will be a maximum of 4 cohorts (25Gy, 30Gy, 35Gy, and 40Gy) in this study assuming no early DLT issues, each containing 3 or 6 patients. Allowance for a -1 cohort arm of 20 Gy in 5 fractions is made in this protocol for early DLT issues. The diagram below displays the schema in more detail.
Any patient that does not complete protocol therapy due to toxicity issues or is unavailable for the 4-week toxicity assessment is considered to be non-evaluable. These patients will need to be replaced in terms of study accrual. Patients are not to be given TKI therapy during the 4 week window post-RT in order to allow for proper evaluation of the RT intervention; however, the treating oncologist ultimately can override this if it is in the best medical interest of the patient (e.g. progressive and symptomatic systemic disease)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Evaluating the Integration of Hypofractionated Renal Ablative Radiotherapy in the Setting of Metastatic Renal Cell Carcinoma|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Arm 1
Level I 20Gy/5 Level II 25Gy/5 Level III 30Gy/5 Level IV 35Gy/5 Level V 40Gy/5
- evaluate the safety/toxicity profile of renal radio-ablation in the setting of metastatic RCC [ Time Frame: After 3 patients have been seen at the 4 week follow up visit, ]toxicity will be assessed using CTCAE v3
- Renal Function post renal radio-ablation [ Time Frame: 4,8,12 wk and every 6months x 5yr ]BUN, Creatinine
- Tumour Response [ Time Frame: 4,8,12 wk and every 6 months x5yr. ]CT abdomen evaluting primary disease using RECIST criteria
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): NCT02264548
|London Regional Cancer Program of the Laswon Research Health Institue|
|London, Ontario, Canada, N6A 4L6|
|Principal Investigator:||Belal Ahmad, MD FRCPC||London Regional Cancer Program of the Lawson Health Research Institute|