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Randomized Study of Stereotactic Body Radiation Therapy (SBRT) in Patients With Oligoprogressive Metastatic Cancers of the Breast and Lung

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ClinicalTrials.gov Identifier: NCT03808662
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is determine if receiving stereotactic body radiation(SBRT) when participants' metastatic tumors have just begun to grow increase the length of time before disease gets worse

Condition or disease Intervention/treatment Phase
TNBC - Triple-Negative Breast Cancer Triple Negative Breast Cancer NSCLC NSCLC Stage IV Non Small Cell Lung Cancer Non Small Cell Lung Cancer Metastatic NSCLC Stage IV Without EGFR/ALK Mutation Radiation: Sterotactic Body Radiotherapy/SBRT Drug: Standard of care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: Early Stereotactic Body Radiotherapy/SBRT
SBRT to all oligoprogressive sites
Radiation: Sterotactic Body Radiotherapy/SBRT
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 Drug: Standard of care
Standard of care per physician discretion




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 48 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 or older
  • Willing and able to provide informed consent
  • Histologically confirmed metastatic TNBC and NSCLC (without EGFR mutation or ALK/ROS1 rearrangement) with metastatic disease detected on imaging. Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
  • 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:

  1. 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
  2. The appearance of one or more new lesions OR
  3. New/malignant FDG uptake in the absence of other indications of progressive disease or an anatomically stable lesion OR
  4. >/= 5mm increase in the diameter sum of the lesion

OR

Using Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) as a guide:

  1. >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
  2. Visible increase in the extent of 18F-FDG tumor uptake OR
  3. 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)
  • No restriction on the total number of metastases
  • 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 fractionation radiation prior to randomization. This will not be counted toward the 5 progressive lesions.

Exclusion Criteria:

  • Pregnancy.
  • Leptomeningeal disease.
  • Progressive pleural disease or peritoneal implants.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808662


Contacts
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Contact: C. Jillian Tsai, MD, PhD 631-623-4268 tsaic@mskcc.org
Contact: Iris Zhi, MD, PhD 631-623-4246 zhiw@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: C. Jillian Tsai, MD, PhD    631-623-4268      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: C. Jillian Tsai, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03808662     History of Changes
Other Study ID Numbers: 18-431
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
SBRT
Stereotactic Body Radiotherapy
Non-hematology metatstatic cancer
non-CNS oligo-progressive disease
intracranial metastatic disease
Memorial Sloan Kettering Cancer Center
18-431

Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms