Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

Phase 3

Active, not recruiting

• Conditions: Metastatic Tumors
• Interventions: Radiation: Palliative Radiation; Drug: Immunotherapy; Drug: Chemotherapy; Drug: Hormones; Other: Observation; Radiation: Stereotactic Ablative Radiotherapy

• Registration Number: NCT03721341
• Lead Sponsor: David Palma

Brief Summary

In patients with a limited oligometastatic burden (cancer has spread but is not yet considered metastatic), emerging evidence suggests that treatment of all sites of disease with ablative therapies can improve patient outcomes, including overall- and progression-free survival. The application of Stereotactic Ablative Radiotherapy (SABR) for patients with 4-10 metastatic deposits appears promising, yet it is unclear if all patients with greater than 3 oligometastatic lesions benefit from ablative therapies in terms of improved Overall Survival (OS), Progression Free Survival (PFS), or quality of life. The purpose of this study is to assess the impact of SABR, compared to standard of care treatment, on overall survival, oncologic outcomes, and quality of life in patients with a controlled primary tumor and 4-10 metastatic lesions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2019-02-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Age 18 or older
• Willing to provide informed consent
• Karnofsky performance score greater than 60
• Life expectancy greater than 6 months
• Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
• Controlled primary tumor defined as: at least 3 months since original tumor treated definitively, with no progression at primary site
• Total number of metastases 4-10
• All sites of disease can be safely treated based on a pre-plan

Exclusion Criteria

• Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.
• For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
• Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases must be discussed with one of the study PIs.
• Malignant pleural effusion
• Inability to treat all sites of disease
• Any single metastasis greater than 5 cm in size.
• Any brain metastasis greater than 3 cm in size or a total volume of brain metastases greater than 30 cc.
• Metastasis in the brainstem
• Clinical or radiologic evidence of spinal cord compression
• Dominant brain metastasis requiring surgical decompression
• Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), mesenteric lymph nodes, or skin
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard arm	Hormones	Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Standard arm	Observation	Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Stereotactic Arm	Immunotherapy	Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Stereotactic Arm	Hormones	Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Stereotactic Arm	Observation	Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Stereotactic Arm	Stereotactic Ablative Radiotherapy	Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Standard arm	Chemotherapy	Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Stereotactic Arm	Chemotherapy	Stereotactic ablative radiotherapy, plus standard of care treatment: chemotherapy, immunotherapy, hormones, or observation given at the discretion of the treating oncologist.
Standard arm	Palliative Radiation	Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.
Standard arm	Immunotherapy	Standard of care treatment: palliative radiotherapy, chemotherapy, immunotherapy, hormones, or observation, is at the discretion of the treating oncologist.

Primary Outcome Measures

Name	Time	Method
Overall Survival at Study Completion	At approximately end of year 6 (study completion)	Time from randomization to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Quality of Life as measured by the Functional Assessment of Cancer Therapy- General (FACT-G) questionnaire	At approximately end of year 6 (study completion)
Overall Survival at midpoint of Study	At approximately year 3 (midpoint)
Quality of Life as measured by the EuroQOL Group EQ-5D-5L questionnaire	At approximately end of year 6 (study completion)
Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	End of years 1, 2, 3, 4, 5, and 6 (study completion)
Progression-free Survival	At approximately year 3, and end of year 6 (study completion)	Time from randomization to disease progression at any site or death.
Time from randomization to development of new metastatic lesions	At approximately end of year 6 (study completion)	New metastatic lesions will be detected using computed tomography, magnetic resonance imaging, and/or bone scans.

Trial Locations

Locations (14)

Alfred Health; 🇦🇺 Melbourne, Victoria, Australia

BC Cancer Agency, Vancouver Island Centre; 🇨🇦 Victoria, British Columbia, Canada

Nova Scotia Health Authortiy; 🇨🇦 Halifax, Nova Scotia, Canada

Grand River Hospital; 🇨🇦 Kitchener, Ontario, Canada

London Regional Cancer Program of the Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada

Trillium Health Partners-Credit Valley Hospital; 🇨🇦 Mississauga, Ontario, Canada

Niagra Health System; 🇨🇦 St. Catharines, Ontario, Canada

Health Sciences North; 🇨🇦 Sudbury, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal-CHUM; 🇨🇦 Montréal, Quebec, Canada

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