Clinical trial · Interventional
Assessing the Efficacy and Safety of Selective Metabolically Adaptive Radiation Dose Escalation in Locally Advanced Non-Small Cell Lung Cancer Receiving Definitive Chemoradiotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Radiation | — | UNRESOLVED |
| Chemoradiotherapy with Integrated Boost Dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemoradiotherapy
- 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.
- interventionNames
- Radiation: Chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy with Integrated Boost Dose
- 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.
- interventionNames
- Radiation: Chemoradiotherapy with Integrated Boost Dose
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRaman 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