Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02710253
Recruitment Status : Recruiting
First Posted : March 16, 2016
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies the side effects and best dose of radiation therapy and to see how well it works in treating patients with cancer that has spread to other places in the body or has increased in size after being treated with immunotherapy. Giving radiation therapy may help to control the cancer after the disease has gotten worse after receiving immunotherapy in patients with cancer that has spread to the other places in the body.

Condition or disease Intervention/treatment Phase
Metastatic Malignant Neoplasm Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Salvage Radiation Therapy to Induce Systemic Disease Regression After Progression on Systemic Immunotherapy
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Experimental: Treatment (SBRT or EBRT)
Patients undergo either 4 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.
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation

Other: Laboratory Biomarker Analysis
Correlative studies

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Number of patients with stable disease assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: At 4 months ]
    To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing immune-related response criteria (ir-RC). Significance testing will assess differences in the frequency of disease control rate via Fisher Exact (if n</=20) or Chi-Squared (if n>20) test.

  2. Objective response (partial response or complete response) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 1 year ]
    To be evaluable for efficacy patients must receive at least one set of systemic imaging >= 4 weeks after completion of radiation. For all control cohorts, efficacy will be evaluated based off of retrospective review of control patients. Corollary investigation will be conducted utilizing ir-RC. Significance testing will assess differences in the frequency of objective response via Fisher Exact (if n</=20) or Chi-Squared (if n>20) test.

  3. Incidence of adverse events assessed with Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]

    To be evaluable for toxicity, patients must be on the trial for at least 8 weeks. For a toxicity to be considered a dose limiting toxicity, the toxicity must be grade 3+ non-dermatologic and non-laboratory, grade 4+ laboratory, or grade 4+ dermatologic. In addition the toxicity must meet the following criteria:

    1. The toxicity must be immune-related.
    2. The toxicity must be attributable to radiation. Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Significance testing will assess differences in dose limiting toxicities via Fisher Exact (if n =< 20) or Chi-Squared (if n > 20) test.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 1 year ]
    Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Differences in overall survival will be compared utilizing Log-Rank test and Cox proportional hazards regression adjusting for factors including treatment group, disease histology, previous response with the most recent immunotherapy based treatment.

  2. Progression free survival [ Time Frame: Up to 1 year ]
    Exploratory analyses will compare specific treatment groups with the corresponding control group when available. Differences in progression free survival will be compared utilizing Log-Rank test and Cox proportional hazards regression adjusting for factors including treatment group, disease histology, previous response with the most recent immunotherapy based treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Pathologically confirmed diagnosis of cancer
  • Progressive disease via Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) on prior study or standard of care therapy utilizing an immunotherapy agent OR a clinical status that requires salvage radiation treatment (e.g.: palliative radiation therapy [RT]) at the discretion of treating physician and/or principal investigator (PI)
  • Be within 6 months (+/-1 week) between last dose of an immunotherapy agent and study enrollment

    • Patients may continue with maintenance immunotherapy as part of standard of care therapy while receiving radiation
  • 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
  • Be willing and able to provide written informed consent/assent for the trial
  • Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 28 days prior to study registration up to the first fraction of radiation;

    • Note: if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • 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

Exclusion Criteria:

  • Has a diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy
  • 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
  • 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 hypothyroidism) 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
  • Has an active infection requiring intravenous systemic therapy or hospital admission
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • 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

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): NCT02710253


Contacts
Layout table for location contacts
Contact: James Welsh, MD 713-563-2300 jwelsh@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: James Welsh    713-563-2300      
Principal Investigator: James Welsh         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: James Welsh M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02710253    
Other Study ID Numbers: 2015-0936
NCI-2016-00682 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0936 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms