Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy
NCT ID: NCT02710253
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2016-05-25
2026-05-30
Brief Summary
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Detailed Description
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I. To identify immunotherapy-based treatments where salvage radiation produces systemic disease control after initial progressive disease.
II. To identify immunotherapy-based treatments where salvage radiation produces a high rate of treatment-related toxicities.
SECONDARY OBJECTIVES:
I. To determine the frequency of systemic disease control (objective response or stable disease) after salvage radiation following progression on immunotherapy among all patients and within each treatment group.
II. Determine the frequency of dose limiting toxicities (DLTs) with salvage radiation after progression on treatment with an immunotherapy agent among all patients and within each treatment group.
III. To determine the rate of systemic objective response among all patients and within each treatment group among all patients and within each treatment group.
IV. To determine the duration of response in patients who achieve disease control among all patients and within each treatment group.
V. To determine the overall survival after salvage radiation among all patients and within each treatment group.
VI. To determine the systemic progression free survival after salvage radiation among all patients and within each treatment group.
OUTLINE:
Patients undergo either 4, 5, or 10 fractions of stereotactic body radiation therapy (SBRT), or 5-15 fractions of external beam radiation therapy (EBRT) to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least stable disease (SD) after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.
After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (SBRT or EBRT)
Patients undergo either 4, 5, or 10 fractions of SBRT, or 5-15 fractions of EBRT to any site of metastatic disease daily for any time between 4 days and 3 weeks as determined by the treating radiation oncologist. Patients with at least SD after the second imaging evaluation may undergo additional SBRT in 4 fractions or EBRT in 3 fractions.
External Beam Radiation Therapy
Undergo EBRT
Laboratory Biomarker Analysis
Correlative studies
Stereotactic Body Radiation Therapy
Undergo SBRT
Interventions
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External Beam Radiation Therapy
Undergo EBRT
Laboratory Biomarker Analysis
Correlative studies
Stereotactic Body Radiation Therapy
Undergo SBRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Progressive disease via irRC on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative RT) at the discretion of treating Physician and/or PI.
3. Previous progression of disease while on treatment of an immunotherapy agent or cell-based therapy.
a. Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation.
4. Have at least one site of metastatic disease amenable to radiation. All lesions amenable to radiation may be irradiated at the discretion of treating Radiation Oncologist, depending on the location, size and number of lesions.
5. Be willing and able to provide written informed consent-for the trial.
6. Be ≥ 18 years of age on day of signing informed consent.
7. Have a performance status of 0-2 on the ECOG performance scale.
8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to first fraction of radiation.
\- Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9. We will allow prior radiation to other sites, with no washout period, prior to study entry as long as the high dose regions of the prior and proposed radiation fields do not overlap or it can overlap, as long as the area being treated is getting low dose radiation; this can be done alone or in combination with high dose to a previously un-irradiated area.
10. Non-English speakers may enroll on the protocol.
Exclusion Criteria
1. Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
2. Has had prior radiation therapy within the past 3 months where the high dose area of the prior radiation would overlap with the high dose area of the intended radiation based on the judgment of the treating radiation oncologist.
3. Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previous treatment.
* Note: Subjects with permanent ≤ Grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidisim) are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Note: Subjects with asymptomatic ≤ Grade 2 laboratory or dermatologic abnormalities are an exception to this criterion and may qualify for the study pending the judgment of the treating radiation oncologist.
4. Has an active infection requiring intravenous systemic therapy or hospital admission.
5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
6. Is pregnant or expecting to conceive or within the projected duration of the trial, starting with the screening visit through 60 days after the last fraction of radiation.
18 Years
ALL
No
Sponsors
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Artidis
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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James Welsh
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson in The Woodlands
Conroe, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
MD Anderson West Houston
Houston, Texas, United States
MD Anderson League City
League City, Texas, United States
MD Anderson in Sugar Land
Sugar Land, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Marc Delclos, M D
Role: primary
James Welsh
Role: primary
Stephen G. Chun, M D
Role: primary
Neelofur R. Ahmad, M D
Role: primary
Isidora Y. Arzu, M D
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2016-00682
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0936
Identifier Type: OTHER
Identifier Source: secondary_id
2015-0936
Identifier Type: -
Identifier Source: org_study_id