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

Non-Small Cell Lung Cancer Clinical Trial

— PET-BOOST  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02788461
• Other study ID #: PET-BOOST NSCLC
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• Chemoradiotherapy
Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
• 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.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ont
Canada	London Regional Cancer Program	London	Ontario
Canada	McGill University Health Centre, Glen site Cedars Cancer Center	Montreal,	Quebec
Canada	Stronach Regional Cancer Centre at Southlake Regional Health Centre	Newmarket,	Ontario
Canada	CHU de Quebec - L'Hôtel-Dieu de Québec	Quebec
Canada	CHUS - Hôpital Fleurimont	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of local-regional failure rate	Primary outcome of the trial is to determine if dose escalation to metabolically active subvolumes will reduce local-regional failure rate	2 years
Secondary	Progression-Free Survival	Determine if dose escalation to metabolically active subvolumes will improve progression-free survival at 2 years	2 years
Secondary	Overall Survival	Determine if dose escalation to metabolically active subvolumes will improve overall survival at 2 years	2 years
Secondary	Grade 3-5 Toxicity Rate	Determine if dose escalation to metabolically active subvolumes will increase the rate of grade 3-5 toxicities	2 years
Secondary	Quality of Life FACT-L	Compare the quality of life in the two arms using Functional Assessment of Cancer Therapy-Lung (FACT-L) instrument	2 years
Secondary	Quality of Life EQ-5D	Compare the quality of life in the two arms using EuroQol Quality of Life-5 Dimensions (EQ-5D) instrument	2 years
Secondary	Dose-Response Characterization	Characterize the tumor dose-response relationship in the experimental arm and create a tumor control probability model for local-regional failure at 2 years	2 years
Secondary	Dose Escalation Feasibility	Explore the feasibility of adaptive dose escalation based on PET response at week 2	2 weeks
Secondary	Imaging Use	Explore the use of Week 0 and Week 2 PET images for prognostication and response assessment for local-regional failure at 2 years	2 years