CompletedPhase 2NCT03128008
Official study title

Locally Advanced NSCLC Hyperfractionated RT

Study summary

This is a prospective phase II study designed to evaluate an accelerated and adaptive RT approach for locally-advanced non-small cell lung cancer (NSCLC). All eligible subjects will have an interim PET-CT during radiation therapy to determine the metabolic complete response rate. Radiation therapy will be given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Interim responses will be assessed using PERCIST criteria. Despite concurrent chemotherapy and radiation therapy, local/regional failure occurs in \~50% of patients with locally-advanced NSCLC. Clinical studies have demonstrated that accelerated fractionation (giving the same total dose in a shorter period of time) improves outcomes in several malignancies, including lung cancer. Administering higher than conventional doses of RT to all sites of original disease leads to inferior outcomes. Adapting the RT approach, giving a higher dose to slowly responding disease as assessed with interim PET has been shown to be feasible. PERCIST (Positron Emission Tomography Response Criteria in Solid Tumors) provides guidelines on how to report responses to therapy based on PET-CT. PET-CT response has been shown to be prognostic in a variety of clinical scenarios in lung cancer including after induction therapy. In one study, PET was performed after neoadjuvant chemoradiotherapy (40-50.4 Gy). Complete or partial metabolic response using PERCIST criteria was predictive of loco-regional, distant, and overall progression-free survival.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCarboplatin and Paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 28, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Duke University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Duke University
Interventions being studied
Drug: Carboplatin; Drug: Paclitaxel; Radiation: Daily hyperfractionated radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Histologic/cytologic documentation of non-small cell lung cancer (NSCLC) 2. Unresectable stage II, IIIA, or IIIB disease 3. Zubrod/ECOG performance status 0-1 4. Weight loss \< 10% in preceding 3 months prior to diagnosis 5. Adequate organ function defined as the following 6. Absolute neutrophil count of ≥ 1,500 and platelet count ≥ 100,000 7. Cockcroft calculated creatinine clearance of ≥ 45 ml/min or 1.5 x the upper limit of normal (ULN) 8. A total bilirubin ≤ 1.5 ULN, aspartate aminotransferase (AST) ≤ 2.0 x ULN 9. ≥ 18 years of age. 10. Negative pregnancy test in women of child-bearing potential 11. Signed study-specific informed consent. 12. No prior chemotherapy or radiotherapy for NSCLC 13. No prior mediastinal or thoracic radiation

Reasons someone may not be able to joinExclusion criteria

1. Prior thoracic irradiation. 2. Medical contraindications to thoracic irradiation. 3. Pre-existing sensory neuropathy of grade ≥ 2 4. Pleural effusion: when pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative. Patients with effusions that are minimal (i.e. not visible on chest x-ray) or that are too small to safely tap are eligible 5. Patients with contralateral hilar involvement

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2021. Always confirm current availability with the study team.

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