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Stereotactic Radiotherapy for Oligo-Progressive Non-Small Cell Lung Cancer (STOP-NSCLC)

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ClinicalTrials.gov Identifier: NCT02756793
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Brief Summary:
A multicenter randomized phase II trial of stereotactic body radiotherapy for oligo-progressive non-small cell lung cancer. Eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. The primary outcome is progression-free survival (PFS).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Radiation: Stereotactic Ablative Radiotherapy (SABR) Other: Standard of Care Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiotherapy for Oligo-Progressive Non-Small Cell Lung Cancer (STOP-NSCLC): A Randomized Phase II Trial
Study Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Standard of Care Treatment

Patient treatment may include the following 3 options, at the discretion of the treating physicians:

  • Continue with current systemic agent(s)
  • Observation
  • Switch to next-line treatment
Other: Standard of Care Treatment

May include:

  • Continue with current systemic agent(s)
  • Observation
  • Switch to next-line treatment

Palliative radiotherapy is allowed in this arm.


Experimental: Stereotactic Ablative Radiotherapy (SABR)
SABR is delivered to all sites of progressive disease with continuation of current systemic agents. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in Arm 1.
Radiation: Stereotactic Ablative Radiotherapy (SABR)
Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 5 years ]
    Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Overall survival is defined as they time from randomization to death from any cause

  2. Quality of Life [ Time Frame: 5 years ]
    Quality of life will be assessed with the Functional Assessment of Cancer Therapy: Lung (FACT-L)

  3. Toxicity [ Time Frame: 5 years ]
    Toxicity will be assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (i.e. liver, lung, bone)

  4. Lesional Control Rate [ Time Frame: 5 years ]
    Local control rate of lesions treated with SABR

  5. Total Time on Chemotherapy [ Time Frame: 5 years ]
  6. Duration of current systemic agent treatment after SABR [ Time Frame: 5 years ]
    Arm 2 only

  7. Location of sites of further progression after SABR [ Time Frame: 5 years ]


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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 to provide informed consent
  • Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) with metastatic disease detected on imaging. Biopsy of metastasis at some time point prior to enrollment is preferred, but not required.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy > 3 months
  • Patient has received treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies) during the past 6 weeks. This most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (CR) prior to the development of oligo-progressive lesions.
  • Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST)-documented progression in up to 5 individual lesions, with no previous radiation or radiofrequency ablation to those sites. Oligoprogression may be defined as:
  • Progression of an individual metastasis according to RECIST 1.1 criteria
  • Unambiguous development of a new metastatic lesion at least 5mm in size
  • Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline
  • All sites of oligoprogression can be safely treated
  • Maximum 3 progressing metastases in any single organ system (i.e. lung, liver, brain, bone), and the total number of metastases must be 5 or less

Note for Patients with Brain Metastases: For patients with brain metastases and oligo-progression elsewhere where stereotactic radiation to the brain is deemed to be warranted, this must be specified prior to randomization. If randomized to Standard Arm, patient would receive stereotactic radiation to brain only. If randomized to Experimental Arm, patient would receive stereotactic radiation to brain and to body lesions

Exclusion Criteria:

  • Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease
  • Prior radiotherapy to a site requiring treatment
  • Malignant pleural effusion
  • Inability to treat all sites of enlarging, oligoprogressive disease
  • Clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI
  • 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): NCT02756793


Contacts
Contact: Devin Schellenberg, MD, FRCPC 604-675-8000 dschellenberg@bccancer.bc.ca
Contact: David Palma, MD, FRCPC 519-685-8500 david.palma@lhsc.on.ca

Locations
Canada, Alberta
Alberta Health Services-Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Zsolt Gabos, MD,FRCPC    780-432-8783    Zsolt.Gabos@albertahealthservices.ca   
Principal Investigator: Zsolt Gabos, MD,FRCPC         
Canada, British Columbia
BC Cancer Agency Branch Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Devin Schellenberg, MD, FRCPC    (604) 930-2098    dschellenberg@bccancer.bc.ca   
Principal Investigator: Devin Schellenberg, MD, FRCPC         
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Palma, MD, FRCPC    519-685-8500    david.palma@lhsc.on.ca   
Principal Investigator: David Palma, MD, FRCPC         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G1X6
Contact: Meredith Guiliani, MBBS, MEd, FRCPC    416-946-2983    Meredith.Giuliani@rmp.uhn.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute

Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02756793     History of Changes
Other Study ID Numbers: STOP NSCLC
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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