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)

Lawson Health Research Institute

Status: Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Treatments: Radiation: Chemoradiotherapy; Radiation: Chemoradiotherapy with Integrated Boost Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02788461

PET-BOOST NSCLC

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Chemoradiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Chemoradiotherapy

Chemoradiotherapy with Integrated Boost Dose

Experimental group

Description:

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.

Treatment:

Radiation: Chemoradiotherapy with Integrated Boost Dose