- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03808662
Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung
Precision Radiation for OligoMetastatIc and MetaStatic DiseasE (PROMISE)-004: Consolidative Use of Radiotherapy to Block (CURB) Oligoprogression
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Princess Margaret Hospital/Ontario Cancer Institute (Data Analysis Only)
-
-
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
Rockville Centre, New York, United States, 11570
- Memorial Sloan Kettering Rockville Centre
-
Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center (Data Analysis Only)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or older
- Willing and able to provide informed consent
- Metastatic disease detected on imaging and histologically confirmed:
Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor
Note:
- Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
- These patients are selected for the study given the similar survival outcomes when given standard of care therapies
- Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
- Patients who received prior immunotherapy are allowed.
- Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.
- Patients with the following medical conditions precluding them from participating in other systemic therapy or drug trials are allowed:
- active liver disease, including viral or other hepatitis, or cirrhosis
- any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
- a permanent pacemaker
- a QTc > 480 ms in the baseline EKG
- peripheral neuropathy of grade >/= 2 per NCI CTCAE
- history or known autoimmune disease
- current chronic systemic steroid therapy or any immunosuppressive therapy
- history of primary immunodeficiency or solid organ transplant
- known positive human immunodeficiency virus (HIV), chronic or active hepatitis B or C, or active hepatitis A
- active infection requiring systemic antibiotic therapy
- Patients can have more than 5 metastases but can only have 1-5 oligo-progressive lesions.
- Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) documented progression in up to 5 individual lesions
Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria as a guide:
- At least a 20% increase in the sum of the longest diameter (LD) of the lesion, taking as reference the smallest sum LD recorded since the last imaging OR
- The appearance of one or more new lesions OR
- New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR
- >/= 5mm increase in the diameter sum of the lesion
OR
Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:
- >30% increase in 18F-FDG SUV peak, with >0.8 SUV units increase in tumor SUV from the baseline scan in pattern typical of tumor and not of infection/treatment effect OR
- Visible increase in the extent of 18F-FDG tumor uptake OR
- New 18F-FDG avid lesions typical of cancer (including new bone lesion) and not related to treatment effect and/or infection
OR
Development of a new soft tissue metastatic lesion at least 5mm in size or any new bone metastasis
OR
Progressive enlargement of a known metastasis on 2 consecutive imaging studies at least 2 months apart with a minimum 5mm increase in size
- All sites of oligoprogression can be safely treated
Maximum 5 progressing metastases in any single extra-cranial organ system (i.e. lung, liver, bone)
a. If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI
- No restriction on the total number of metastases
- Note: If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
- For patients with brain metastases and oligoprogression elsewhere where stereotactic radiation to the brain is warranted, the brain lesions can be treated prior to randomization. This will not be counted toward the 5 progressive lesions.
Any symptomatic metastatic sites requiring prompt palliative radiation (e.g. cord compression) can also be treated with standard of care radiation prior to randomization. This will not be counted toward the 5 progressive lesions.
- If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI.
Exclusion Criteria:
- Pregnancy.
- Leptomeningeal disease.
- Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma.
- Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: Early Stereotactic Body Radiotherapy/SBRT
SBRT to all oligoprogressive sites
|
In general, it is recommended using 9-10 Gy x 3 or 10 Gy x 5 fractions given every other day.
Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance.
All lesions are recommended to receive a biologically effective dose (BED) of 60 Gy or higher (BED10≥70), assuming α/β ratio of 10 and using the linear-quadratic model: BED = nd x [1 + d/(α/β)] where n is number of fractions and d is dose per fraction.
Sometimes BED ≥80 Gy is preferred, with lower doses ≥50 Gy allowed at the discretion of the treating physician for concerns about normal tissue toxicity.
|
Active Comparator: Arm 2:Standard of Care
|
Standard of care per physician discretion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Up to 52 weeks after final participant is enrolled
|
To study if the addition of early SBRT to extra-cranial oligo-progressive metastatic disease could prolong PFS compared to no SBRT.
PFS is defined as the time from randomization to disease progression or death.
|
Up to 52 weeks after final participant is enrolled
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadeem Riaz, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-431
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NSCLC
-
Shanghai Henlius BiotechCompleted
-
The Netherlands Cancer InstituteEnrolling by invitation
-
Centre Oscar LambretUniversity Hospital, LilleTerminated
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdCompleted
-
Bio-Thera SolutionsCompleted
-
Jiangsu Province Nanjing Brain HospitalRecruiting
-
TYK Medicines, IncRecruiting
-
Radboud University Medical CenterPfizer; ImaginAb, Inc.; University Hospital TuebingenNot yet recruitingNSCLCGermany, Netherlands
-
Beta Pharma, Inc.Completed
Clinical Trials on Sterotactic Body Radiotherapy/SBRT
-
Dr. Gerard MortonRecruitingProstate CancerCanada
-
University of LeedsNot yet recruitingProstate Cancer | Radiotherapy Side Effect
-
Duke UniversityGateway for Cancer ResearchActive, not recruiting
-
The Netherlands Cancer InstituteCompletedLung Cancer | Metastatic Lung CancerNetherlands, United States, Canada, Germany
-
European Organisation for Research and Treatment...UnknownNon-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIGermany, Belgium, United Kingdom, Switzerland
-
Memorial Sloan Kettering Cancer CenterRecruitingBreast Cancer | Metastatic Breast Cancer | ER+ Breast Cancer | Metastatic Breast Carcinoma | HER2+ Breast Cancer | Oligometastatic Breast CarcinomaUnited States
-
Istituto Clinico HumanitasRecruiting
-
Royal North Shore HospitalRecruiting
-
Regina Elena Cancer InstituteAzienda Sanitaria-Universitaria Integrata di Udine; San Giovanni Addolorata...Recruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruiting