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Locally Advanced NSCLC Hyperfractionated RT (ADAPT)

This study is currently recruiting participants.
Verified November 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03128008
First Posted: April 25, 2017
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose

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 Intervention Phase
Carcinoma, Non Small Cell Lung (NSCLC) Drug: Carboplatin Drug: Paclitaxel Radiation: Daily hyperfractionated radiation therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Accelerated and Adaptive Radiation Therapy for Locally-Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 61
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: July 2025
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Carboplatin
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.
Drug: Paclitaxel
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Tykeytra Dale, BSN MS 919 6683726 tykeytra.dale@dm.duke.edu
Contact: Joan Cahill, BNS OCN CCRP 919 6683726

Locations
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      
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Health System
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03128008     History of Changes
Other Study ID Numbers: Pro00083154
First Submitted: April 18, 2017
First Posted: April 25, 2017
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action