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Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02019576
First received: November 25, 2013
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Clear Cell Metastatic Renal Cell Carcinoma Radiation: Stereotactic radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Metastatic Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • To evaluate local control at one year of metastases treated with stereotactic radiotherapy in patients who present with oligo-progression while receiving first-line treatment with Sunitinib. [ Time Frame: 3 years ]
    Patients will have evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria. All progressing metastases sites will be amenable to stereotactic radiotherapy. The primary endpoint of local control will be defined as the absence of local failure in the irradiated site(s). Progressive enlargement will be defined as a 20% enlargement observed on two consecutive scans from baseline scan.


Secondary Outcome Measures:
  • To evaluate progression free survival after stereotactic radiotherapy while continuing to receive first-line systemic therapy with Sunitinib. [ Time Frame: 3 years ]
    Progression free survival will be evaluated via disease assessments of radiology scans completed every three months from the time of stereotactic radiotherapy until progression is confirmed. Progressive disease will be defined as a 20% increase in RECIST 1.1 criteria measurements observed on two consecutive scans from the baseline scan.

  • To evaluate the acute and late toxicity to stereotactic radiotherapy. [ Time Frame: 3 years ]
    Acute and late toxicities to stereotactic radiotherapy will be assessed from adverse events, vital signs and by clinically significant changes in laboratory evaluations. Adverse events will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. These events will be followed until resolution or for a maximum of two years, which ever occurs first.


Estimated Enrollment: 68
Study Start Date: May 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019576

Contacts
Contact: Georg A. Bjarnason, MD, FRCPC 416-480-5847 georg.bjarnason@sunnybrook.ca
Contact: Nesan Bandali, RN 416-480-6100 ext 82139 nesan.bandali@sunnybrook.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Gerald Lim, MD       Gerald.Lim@albertahealthservices.ca   
Principal Investigator: Gerald Lim, MD         
Sub-Investigator: Daniel Heng, MD         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Samir Patel, MD       Samir.Patel2@albertahealthservices.ca   
Principal Investigator: Samir Patel, MD         
Sub-Investigator: Scott North, MD         
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Christian Kollmannsberger, MD       ckollmannsberger@bccancer.bc.ca   
Principal Investigator: Christian Kollmannsberger, MD         
Canada, Manitoba
Manitoba CancerCare Institute Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Arbind Dubey, MD       adubey@cancercare.mb.ca   
Sub-Investigator: Piotr Czaykowski, MD         
Principal Investigator: Arbind Dubey, MD         
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Lori Wood, MD       lori.wood@cdha.nshealth.ca   
Principal Investigator: Lori Wood, MD         
Sub-Investigator: Derek Wilke, MD         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Anand Swaminath, MD       Anand.swaminath@jcc.hhsc.ca   
Principal Investigator: Anand Swaminath, MD         
Sub-Investigator: Sebastian Hotte, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Belal Ahmad, MD       Belal.Ahmad@lhsc.on.ca   
Principal Investigator: Belal Ahmad, MD         
Sub-Investigator: George Rodrigues, MD         
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Scott Morgan, MD       smorgan@Ottawahospital.on.ca   
Principal Investigator: Scott Morgan, MD         
Sub-Investigator: Christina Canil, MD         
Odette Cancer Centre, Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Georg Bjarnason, MD, FRCPC    416-480-5847    georg.bjarnason@sunnybrook.ca   
Contact: Nesan Bandali, RN    416-480-6100 ext 82139    nesan.bandali@sunnybrook.ca   
Principal Investigator: Georg Bjarnason, MD, FRCPC         
Principal Investigator: Patrick Cheung, MD         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srikala Sridhar, MD       srikala.sridhar@uhn.on.ca   
Principal Investigator: Srikala Sridhar, MD         
Sub-Investigator: Anthony Brade, MD         
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Fabio Cury, MD       fabio.cury@gmail.com   
Principal Investigator: Fabio Cury, MD         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Tamim Niazi, MD       tniazi@jgh.mcgill.ca   
Principal Investigator: Tamim Niazi, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Pfizer
Investigators
Principal Investigator: Georg A. Bjarnason, MD, FRCPC Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: Patrick Cheung, MD, FRCPC Toronto Sunnybrook Regional Cancer Centre
  More Information

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02019576     History of Changes
Other Study ID Numbers: OZM-053
Study First Received: November 25, 2013
Last Updated: May 2, 2017

Keywords provided by Sunnybrook Health Sciences Centre:
Metastatic renal cell carcinoma
mRCC
Clear cell

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 22, 2017