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

NCT02788461 | Active Not Recruiting DMC

• 1 other identifier: PET-BOOST NSCLC
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Progression-Free Survival

  2 years

• Overall Survival

  2 years

• Grade 3-5 Toxicity Rate

  2 years

• Quality of Life FACT-L

  2 years

• Quality of Life EQ-5D

  2 years

Study Arms (2)

Chemoradiotherapy

ACTIVE COMPARATOR

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

Chemoradiotherapy with Integrated Boost Dose

EXPERIMENTAL

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

Interventions

Chemoradiotherapy RADIATION

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

Chemoradiotherapy

Chemoradiotherapy with Integrated Boost Dose RADIATION

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.

Chemoradiotherapy with Integrated Boost Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (7)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Stronach Regional Cancer Centre at Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre, Glen site Cedars Cancer Center

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Quebec - L'Hôtel-Dieu de Québec

Québec, Quebec, G2L 2Z3, Canada

Location

CHUS - Hôpital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Raman S, Bissonnette JP, Warner A, Le L, Bratman S, Leighl N, Bezjak A, Palma D, Schellenberg D, Sun A. Rationale and Protocol for a Canadian Multicenter Phase II Randomized Trial Assessing Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-small-cell Lung Cancer (NCT02788461). Clin Lung Cancer. 2018 Sep;19(5):e699-e703. doi: 10.1016/j.cllc.2018.05.002. Epub 2018 May 16.

  PMID: 29903551 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: June 2, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)