N/A
N=47
A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT02492867 ↗Enrolled (actual)
47
Serious AEs
27.7%
Results posted
Sep 2024
Primary outcome: Primary: The Number of Patients for Whom Treatment is Feasible. — 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Response-driven Adaptive Radiation Therapy (Radiation); Carboplatin (Drug); Paclitaxel (Drug); FDG-PET (Device); V/Q SPECT (Device); Durvalumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients for Whom Treatment is Feasible. |
40 | — |
| PRIMARY The Number of Patients That Experience Grade 2 or Greater Lung Toxicity |
8; 1; 6; 0; 1 | — |
| PRIMARY The Number of Patients That Experience Grade 2 or Greater Esophageal Toxicity |
1; 9; 7 | — |
| PRIMARY Comparison of Delivered Dose to Dose That Would Have Been Administered Using the Criteria Described in Protocol UMCC 2007.123 (NCT01190527) |
80.4; 67.7 | — |
| SECONDARY Time to Local Progression |
69.2; 47.9 | — |
| SECONDARY Overall Survival Time |
82.8; 62.3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02492867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.