NCT02019576

Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Metastatic Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Stereotactic radiotherapy (SRT) is a newer type of focused radiation therapy that precisely and accurately delivers high dose radiation to a tumour, while sparing much of the nearby normal organs. The use of stereotactic radiotherapy results in high rates of tumour destruction with minimal side effects which are very well tolerated. Often stereotactic radiotherapy has been used to try to cure patients who have an early stage cancer which has not spread, but there is less experience with using it in patients with cancer which has spread. The purpose of this study is to measure how well stereotactic radiotherapy can destroy kidney cancer tumours which are no longer being controlled by Sunitinib and to measure how much longer such an approach will allow patients to stay on Sunitinib before needing to switch to another medication. Stereotactic radiotherapy will be used to treat only the growing tumours and then patients will continue with Sunitinib.

Conditions

• Clear Cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic radiotherapy	SRT to all areas of oligo-progression as follows: BRAIN: 20-24 Gy in 1 fraction if \< 2 cm,18 Gy in 1 fraction if 2-3 cm,15 Gy in 1 fraction for 3-4 cm, alternatively 25-30 Gy in 5 fractions can be used; SPINE: 18-24 Gy in 1-2 fractions,24 Gy in 3 fractions or 30-40 Gy in 5 fractions; NON-SPINE BONE: 30-40 Gy in 5 fractions; LUNG: 48-60 Gy in 4 fractions or 54-60 Gy in 3 fractions for peripheral lung tumours,50 Gy in 5 fractions or 60 Gy in 8 fractions for central lung tumours; LIVER: 30-60 Gy in 3-6 fractions,higher doses for central liver lesions and lower doses for peripheral liver lesions depending on proximity to adjacent organ (stomach, small bowel, large bowel or kidney); ADRENAL OR KIDNEY TUMOURS: 30-40 Gy in 5 fractions; LYMPHADENOPATHY: 30-40 Gy in 5 fractions.

Timeline

• Start date: 2014-05-01
• Primary completion: 2021-02-16
• Completion: 2021-03-04
• First posted: 2013-12-24
• Last updated: 2021-03-23

Locations

12 sites across 1 country: Canada