Locally Advanced NSCLC Hyperfractionated RT
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/24/2018 |
| Start Date: | December 7, 2017 |
| End Date: | July 2025 |
| Contact: | Tykeytra Dale, BSN MS |
| Email: | tykeytra.dale@dm.duke.edu |
| Phone: | 919 6683726 |
Phase II Study of Accelerated and Adaptive Radiation Therapy for Locally-Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
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.
Inclusion 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
Exclusion 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
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