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Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy (PET-BOOST)

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ClinicalTrials.gov Identifier: NCT02788461
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Brief Summary:
A randomized phase II trial to assess the efficacy and safety of selective metabolically adaptive radiation dose escalation in locally advanced non-small cell lung cancer receiving definitive chemoradiotherapy. Eligible and consenting patients will be randomized to receive conventional chemoradiotherapy or chemoradiotherapy with a radiation (RT) integrated boost. All patients will receive a fludeoxyglucose-positron emission tomography (FDG-PET) scan within two weeks prior to starting treatment. The primary outcome is to determine if dose escalation to metabolically active tumor subvolumes will reduce local-regional failure rate at 2 years.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Radiation: Chemoradiotherapy Radiation: Chemoradiotherapy with Integrated Boost Dose Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial to Assess the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy
Study Start Date : May 2016
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Chemoradiotherapy
Patients randomized to the standard arm will receive radiotherapy (5x per week) of 60 gray (Gy) in 30 fractions with concurrent cisplatin and etoposide chemotherapy.
Radiation: Chemoradiotherapy
Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.

Experimental: Chemoradiotherapy with Integrated Boost Dose
Patients randomized to the experimental arm will receive radiotherapy (5x per week) with an integrated boost dose of up to 85Gy in 30 fractions to tumor subvolumes, with concurrent cisplatin and etoposide chemotherapy.
Radiation: Chemoradiotherapy with Integrated Boost Dose
Patients will receive an RT integrated boost to tumor subvolumes (max boost dose of 85Gy) in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.




Primary Outcome Measures :
  1. Reduction of local-regional failure rate [ Time Frame: 2 years ]
    Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate


Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 2 years ]
    Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years

  2. Overall Survival [ Time Frame: 2 years ]
    Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years

  3. Grade 3-5 Toxicity Rate [ Time Frame: 2 years ]
    Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities

  4. Quality of Life FACT-L [ Time Frame: 2 years ]
    Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument

  5. Quality of Life EQ-5D [ Time Frame: 2 years ]
    Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument

  6. Dose-Response Characterization [ Time Frame: 2 years ]
    Characterize the tumor dose-response relationship in the experimental arm and create a tumor control probability model for local-regional failure at 2 years

  7. Dose Escalation Feasibility [ Time Frame: 2 weeks ]
    Explore the feasibility of adaptive dose escalation based on PET response at week 2

  8. Imaging Use [ Time Frame: 2 years ]
    Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 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:

  • Patients who are at least 18 years old and are able to consent
  • Patients who will undergo Chemo-RT as primarily modality of treatment
  • Patients with a primary tumor or node measuring at least 10mm on CT scan
  • Patients with a PET avid tumor having Standardized Uptake Values (SUV) > 4
  • Patients with Eastern Cooperative Oncology Group (ECOG) status 0-2 within 4 weeks of randomization

Exclusion Criteria:

  • Trimodality patients who have surgery as part of curative treatment
  • Previous radiotherapy to intended treatment volumes
  • Active invasive malignancy other than lung cancer
  • Active pregnancy
  • Poor respiratory function (Forced Expiratory Volume < 1.0 or Diffusing Capacity < 50% age-adjusted normal)
  • ECOG status > 2
  • Pre-treatment complete blood count/differential showing inadequate bone marrow reserve (absolute neutrophil count < 1800 cells/mm3 or platelets < 100 000 cells/mm3 or hemoglobin < 90g/L), measured within 4 weeks of registration
  • AST, ALT or total bilirubin > 2.5 times the upper limit of normal, measured within 4 weeks of registration
  • Unintentional weight loss >10% over 3 months within 4 weeks of registration
  • Severe active co-morbidity defined by:
  • Significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction
  • Transmural myocardial infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
  • Acquired immune deficiency syndrome (AIDS) based on the current Centre for Disease Control definition; note, however, that HIV testing is not required for entry into this protocol

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): NCT02788461


Contacts
Contact: Alex Sun, MD, FRCPC 416 946 4545 alex.sun@rmp.uhn.on.ca
Contact: David Palma, MD, FRCPC 519-685-8500 david.palma@lhsc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: David Palma, MD    519-685-8500    david.palma@lhsc.on.ca   
Stronach Regional Cancer Centre at Southlake Regional Health Centre Recruiting
Newmarket,, Ontario, Canada, L3Y 2P9
Contact: Mojgan Taremi, MD, FRCPC    905-895-4521 ext 6595    mtaremi@southlakeregional.org   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Alex Sun, MD, FRCPC    (416) 946-2000    alex.sun@rmp.uhn.on.ca   
Canada, Ont
Kingston General Hospital Recruiting
Kingston, Ont, Canada, K7L 2V7
Contact: Allison Ashworth, MD, FRCPC    613-544-2631 ext 8106    allison.ashworth@krcc.on.ca   
Canada, Quebec
McGill University Health Centre, Glen site Cedars Cancer Center Recruiting
Montreal,, Quebec, Canada, H4A 3J1
Contact: Sergio L. Faria, MD, PhD    (514) 934-1934 ext 36157      
Contact: Marianna Perna    (514) 934-1934 ext 43191    marianna.perna@muhc.mcgill.ca   
Canada
CHU de Quebec - L'Hôtel-Dieu de Québec Recruiting
Quebec, Canada, G2L 2Z3
Contact: Anne Dagnault, MD PhD    1 418-525-4444, ext 15264    anne.dagnault@mail.chuq.qc.ca   
Contact: Josee Allard;    (418) 525-4444 ext 16730    Josee.Allard@chudequebec.ca   
Sponsors and Collaborators
Lawson Health Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02788461     History of Changes
Other Study ID Numbers: PET-BOOST NSCLC
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 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
Etoposide phosphate
Cisplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action