Stereotactic Radiotherapy for Metastatic Kidney Cancer Being Treated With Sunitinib

NCT02019576 | Completed Phase 2

• 1 other identifier: OZM-053
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 12

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.

Conditions

Clear Cell Metastatic Renal Cell Carcinoma

Keywords

Metastatic renal cell carcinoma; mRCC; Clear cell

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  3 years

Secondary Outcomes (2)

• To evaluate progression free survival after stereotactic radiotherapy while continuing to receive first-line systemic therapy with Sunitinib.

  3 years

• To evaluate the acute and late toxicity to stereotactic radiotherapy.

  3 years

Study Arms (1)

Stereotactic radiotherapy (SRT)

OTHER

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

Interventions

Stereotactic radiotherapy RADIATION

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.

Also known as: SRT

Stereotactic radiotherapy (SRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Able and willing to provide written informed consent and to comply with the study procedures.
• Karnofsky performance status of ≥ 80%.
• 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.
• Histologic confirmation of renal cell carcinoma with a clear cell component.
• Evidence of measurable disease according to RECIST 1.1 criteria.
• 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.
• 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.)
• All progressing metastases are amenable to stereotactic radiotherapy.
• 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.

You may not qualify if:

• Evidence of spinal cord compression.
• Inability to safely treat all sites of progressing metastases.
• Prior malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
• Concurrent administration of other anti-cancer therapy apart from first-line sunitinib.
• Diagnosis of ataxia telangiectasia or active collagen vascular disease.
• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Pfizer: collaborator

Study Sites (12)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Manitoba CancerCare Institute

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Clear-cell metastatic renal cell carcinoma; Carcinoma, Renal Cell

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Georg A. Bjarnason, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

• Patrick Cheung, MD, FRCPC

  Toronto Sunnybrook Regional Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase II study, single arm study, open-label, safety and efficacy study

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 24, 2013
• Study Start: May 1, 2014
• Primary Completion: February 16, 2021
• Study Completion: March 4, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

CA (12)