Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

NCT02019576

Last updated date
Study Location
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clear Cell Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Age ≥ 18 years.

2. Able and willing to provide written informed consent and to comply with the study procedures.

3. Karnofsky performance status of ≥ 80%.

4. Favorable or intermediate Heng prognostic group defined as having two or less of the following factors: hemoglobin < LLN; serum corrected calcium > ULN; Karnofsky performance status < 80%; time from initial diagnosis to initiation of therapy < 1 year; absolute neutrophil count > ULN; platelet count > ULN.

5. Histologic confirmation of renal cell carcinoma with a clear cell component.

6. Evidence of measurable disease according to RECIST 1.1 criteria.

7. Already receiving first-line sunitinib therapy for at least 3 months with at least one imaging compared to baseline (or a CT from one year prior to the date of registration for patients that have been on Sunitinib therapy for over one year) that shows response or stable disease per RECIST v1.1, in all metastatic lesions (Note: SD by RECIST that allows ≤ 19% increase is allowed). Prior immunotherapy including interferon, IL-2, and checkpoint inhibitors is allowed before Sutent.

8. Radiographic evidence of ≤ 5 metastatic lesions progressing. Of the 5 progressing lesions, a maximum of 3 lesions can be in soft tissue. (Ex. If no bone metastases progressing: a maximum of 3 soft tissue lesions. If bone metastases progressing: a maximum of 5 total lesions and a maximum of 3 in soft tissue.)

9. All progressing metastases are amenable to stereotactic radiotherapy.

10. Each progression metastases fulfills at least 1 of the 3 following criteria for oligo-progression: a. Progression of an individual metastasis according to RECIST 1.1 criteria (≥ 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during first line systemic therapy and associated with a 5 mm minimum increase in size); b. Unambiguous development of a new metastatic lesion from the time of scan taken prior to starting first-line therapy with sunitinib; c. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart, while receiving first-line therapy with sunitinib, with a minimum 5 mm increase in size from baseline.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Evidence of spinal cord compression.


2. Inability to safely treat all sites of progressing metastases.


3. Prior malignancy within the past 5 years, excluding non-melanoma skin cancer and
in-situ cancer.


4. Concurrent administration of other anti-cancer therapy apart from first-line
sunitinib.


5. Diagnosis of ataxia telangiectasia or active collagen vascular disease.


6. Other condition, illness, psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or stereotactic radiotherapy
administration, or may interfere with the interpretation of study results and in the
judgment of the investigator would make the patient inappropriate for entry into this
study.

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Clear Cell Metastatic Renal Cell CarcinomaStereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib
NCT02019576
  1. Calgary, Alberta
  2. Edmonton, Alberta
  3. Vancouver, British Columbia
  4. Winnipeg, Manitoba
  5. Halifax, Nova Scotia
  6. Hamilton, Ontario
  7. London, Ontario
  8. Ottawa, Ontario
  9. Toronto, Ontario
  10. Toronto, Ontario
  11. Montreal, Quebec
  12. Montreal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib
Official Title  ICMJE A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Metastatic Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Clear Cell Metastatic Renal Cell Carcinoma
Intervention  ICMJE 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.
Other Name: SRT
Study Arms  ICMJE Stereotactic radiotherapy (SRT)
Stereotactic radiotherapy will be administered for up to five areas of metastatic sites showing oligo-progression within the same time period. During the Sunitinib break period, stereotactic radiotherapy will be delivered in a single fraction or up to a maximum of eight fractions. The number of fractions will depend on how many sites are being irradiated.
Intervention: Radiation: Stereotactic radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2017)
68
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2013)
64
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ? 18 years.
  2. Able and willing to provide written informed consent and to comply with the study procedures.
  3. Karnofsky performance status of ? 80%.
  4. Favorable or intermediate Heng prognostic group defined as having two or less of the following factors: hemoglobin < LLN; serum corrected calcium > ULN; Karnofsky performance status < 80%; time from initial diagnosis to initiation of therapy < 1 year; absolute neutrophil count > ULN; platelet count > ULN.
  5. Histologic confirmation of renal cell carcinoma with a clear cell component.
  6. Evidence of measurable disease according to RECIST 1.1 criteria.
  7. Already receiving first-line sunitinib therapy for at least 3 months with at least one imaging compared to baseline (or a CT from one year prior to the date of registration for patients that have been on Sunitinib therapy for over one year) that shows response or stable disease per RECIST v1.1, in all metastatic lesions (Note: SD by RECIST that allows ? 19% increase is allowed). Prior immunotherapy including interferon, IL-2, and checkpoint inhibitors is allowed before Sutent.
  8. Radiographic evidence of ? 5 metastatic lesions progressing. Of the 5 progressing lesions, a maximum of 3 lesions can be in soft tissue. (Ex. If no bone metastases progressing: a maximum of 3 soft tissue lesions. If bone metastases progressing: a maximum of 5 total lesions and a maximum of 3 in soft tissue.)
  9. All progressing metastases are amenable to stereotactic radiotherapy.
  10. Each progression metastases fulfills at least 1 of the 3 following criteria for oligo-progression: a. Progression of an individual metastasis according to RECIST 1.1 criteria (? 20% enlargement of the tumour vs. baseline or nadir, taking as reference the smallest diameter seen prior to starting or during first line systemic therapy and associated with a 5 mm minimum increase in size); b. Unambiguous development of a new metastatic lesion from the time of scan taken prior to starting first-line therapy with sunitinib; c. Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2-3 months apart, while receiving first-line therapy with sunitinib, with a minimum 5 mm increase in size from baseline.

Exclusion Criteria:

  1. Evidence of spinal cord compression.
  2. Inability to safely treat all sites of progressing metastases.
  3. Prior malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
  4. Concurrent administration of other anti-cancer therapy apart from first-line sunitinib.
  5. Diagnosis of ataxia telangiectasia or active collagen vascular disease.
  6. Other condition, illness, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or stereotactic radiotherapy administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02019576
Other Study ID Numbers  ICMJE OZM-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Georg A. Bjarnason, MD, FRCPCToronto Sunnybrook Regional Cancer Centre
Principal Investigator:Patrick Cheung, MD, FRCPCToronto Sunnybrook Regional Cancer Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP