Locally Advanced NSCLC Hyperfractionated RT (ADAPT)
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|ClinicalTrials.gov Identifier: NCT03128008|
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non Small Cell Lung (NSCLC)||Drug: Carboplatin Drug: Paclitaxel Radiation: Daily hyperfractionated radiation therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Accelerated and Adaptive Radiation Therapy for Locally-Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||December 7, 2017|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2025|
Experimental: Carboplatin/Paclitaxel with radiation therapy
Single arm, non randomized, open label study. Eligible subjects will receive standard of care Carboplatin IV once a week, Paclitaxel IV once a week given concurrently with daily hyperfractionated radiation therapy (RT). RT will be delivered as 6 fractions weekly.
Single arm non randomized open label study. Subjects will recieve standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
Radiation: Daily hyperfractionated radiation therapy
All subjects will recieve 6 fractions(2Gy per fraction) of radiation therapy weekly. All subjects will complete an interim PET-CT after 48Gy-54Gy of RT . Subjects with a complete response on PET will complete RT at 60 Gy; subjects who have residual disease on interim PET and meet strict planning constraints eligibility will proceed to boost RT for a total RT dose of 72Gy. Interim PET-CT response will be measured using PERCIST criteria.
- The metabolic complete response rate, assessed using interim PET-CT, in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy [ Time Frame: 5 years ]For the cohort of the subjects who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.
- The number of subjects eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy [ Time Frame: 5 years ]In the same subject cohort, the proportion of the subjects who are eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy, will be estimated as well as its confidence interval.
- Overall survival with an accelerated and adaptive RT approach. [ Time Frame: 8 years ]The overall survival (OS) for the treated subjects will be characterized by Kalan-Meier estimator. The medial OS will be estimated with a 95% confidence interval.
- Progression-free survival (PFS) with an accelerated and adaptive RT approach. [ Time Frame: 8 years ]Median progression-free survival for subjects will be characterized by Kalan-Meier estimator. The median PFS will be estimated as well as their 95% confidence intervals.
- Local control with an accelerated and adaptive RT approach [ Time Frame: 8 years ]The local control rate for the same cohort of subjects will be measured by standard of care imaging per NCCN guidelines at routine follow up clinic visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128008
|Contact: Tykeytra Dale, BSN MS||919 firstname.lastname@example.org|
|Contact: Joan Cahill, BNS OCN CCRP||919 6683726|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Joan Cahill, BNS OCN CCRP 919-668-3726|
|Contact: Tykeytra Dale, BSN MS 919 6683726|
|Principal Investigator:||Christopher Kelsey, MD||Duke University Health System|