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A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02492867
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : December 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:

Successful treatment of lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in the patient's body and seek to limit any unnecessary radiation to normal parts of the body. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) ("a PET scan") and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT) ("a perfusion scan"), before treatment and then again during treatment to see if this scanning helps predict how well the treatment works and how well the lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of the whole body and areas of active cancer. V/Q SPECT is an image mapping tool that helps assess how well the lungs are working. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where the cancer or the healthy lung is located.

The researchers are also doing blood and urine tests in this study to look for markers to see if this helps them determine the patient's risk of developing side effects from radiation to the lungs. The researchers hope by using these types of tests that they can have more information to help decrease the amount of toxicity patients have from this type of treatment. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Radiation: Response-driven Adaptive Radiation Therapy Drug: Carboplatin Drug: Paclitaxel Device: FDG-PET Device: V/Q SPECT Drug: Durvalumab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : January 14, 2016
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Response-driven Adaptive RT
Patients will receive treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may also receive concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may receive consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist.
Radiation: Response-driven Adaptive Radiation Therapy
Drug: Carboplatin
AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV

Drug: Paclitaxel
40 mg/m^2 IV concurrent with RT; 200 mg/m^2 during consolidation. Given IV

Device: FDG-PET
Other Name: Positron Emission Tomography Scan

Device: V/Q SPECT
Other Name: Single-photon Emission Computed Tomography Scan

Drug: Durvalumab
10 mg/kg during consolidation. Given IV




Primary Outcome Measures :
  1. The number of patients for whom treatment is feasible. [ Time Frame: 6 weeks (30 treatments, 5 days per week) ]
    To determine the feasibility of the proposed adaptive treatment strategy, we will look at the number of patients for whom treatment is feasible. Treatment is feasible if we are able to deliver the full treatment, using the image based spatial replanning and complete the cytokine assays in a short enough timeframe to adapt radiation dose.

  2. The number of patients that experience grade 2 or greater lung toxicity [ Time Frame: Up to 24 months ]
    Lung toxicity will be graded using CTCAE v4.0. These will include, but not be limited to: cough, dyspnea, pneumonitis, radiation pneumonitis, and radiographic or clinical pulmonary fibrosis.

  3. The number of patients that experience grade 2 or greater esophageal toxicity [ Time Frame: Up to 3 months ]
    Esophageal toxicities will be graded using CTCAE v4.0. These will include, but not be limited to esophagitis.

  4. Comparison of delivered dose to dose that would have been administered using the criteria described in protocol UMCC 2007.123 (NCT01190527) [ Time Frame: 6 weeks (30 treatments, 5 days per week) ]
    Investigators will generate the treatment plan (and hence dose to PET avid region) each patient would have received if they had been treated on protocol UMCC 2007.123 (NCT01190527), which redistributed dose to the PET avid region but not through normal tissue. These dose values will then be compared to the doses actually given to assess for any mean differences.


Secondary Outcome Measures :
  1. Time to local progression [ Time Frame: Up to 60 months ]
    Defined as the time from start of treatment to time of local/regional progression on PET, summarized with the Kaplan-Meier method.

  2. Overall survival time [ Time Frame: Up to 60 months ]
    Defined as the time from start of treatment to death.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must have FDG-avid and pathologically proven Stage IIA-IIIB non-small cell lung cancer.
  • Patients must be considered unresectable or inoperable.
  • Patients must be 18 years of age or older.
  • Patients must have a Karnofsky performance (A measure general well-being and activities of daily life. Scores range between 0 and 100 where 100 represents normal and 0 represents death.) of score > or = to 70.
  • Patients must have adequate organ and marrow function.
  • Patient must be willing to use effective contraception if female with reproductive capability.
  • Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Patients with any component of small cell lung carcinoma
  • Patients with evidence of a malignant pleural or pericardial effusion
  • Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints
  • Patients cannot tolerate concurrent chemotherapy
  • Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
  • Prisoners are excluded for this study.

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): NCT02492867


Locations
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United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Shruti Jolly, M.D. University of Michigan Rogel Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02492867    
Other Study ID Numbers: UMCC 2015.035
HUM00098202 ( Other Identifier: University of Michigan )
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Additional relevant MeSH terms:
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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
Carboplatin
Durvalumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological