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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT02492867
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Response-driven Adaptive Radiation Therapy — RADIATION
  • Carboplatin — DRUG
    AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV
  • Paclitaxel — DRUG
    40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV
  • FDG-PET — DEVICE
  • V/Q SPECT — DEVICE
  • Durvalumab — DRUG
    10 mg/kg during consolidation. Given IV

Study Details

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.

Key Dates

Start date
Jan 14, 2016
Status verified
Aug 2024
Primary completion
Nov 28, 2021
Completion
Apr 21, 2022

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The Number of Patients for Whom Treatment is Feasible. [ Time Frame: 6 weeks (30 treatments, 5 days per week) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Michigan Cancer CenterAnn ArborMichigan48109-
VA Ann Arbor Healthcare SystemAnn ArborMichigan48105-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Cancer Center· Ann Arbor, MIVA Ann Arbor Healthcare System· Ann Arbor, MI

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