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

NCT02492867 | Completed Results DMC

• 3 other identifiers: UMCC 2015.035HUM00098202P01CA059827
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (4)

• The Number of Patients for Whom Treatment is Feasible.

  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.

  6 weeks (30 treatments, 5 days per week)

• The Number of Patients That Experience Grade 2 or Greater Lung Toxicity

  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.

  Up to 24 months

• The Number of Patients That Experience Grade 2 or Greater Esophageal Toxicity

  Esophageal toxicities will be graded using CTCAE v4.0. These will include, but not be limited to esophagitis.

  Up to 3 months

• Comparison of Delivered Dose to Dose That Would Have Been Administered Using the Criteria Described in Protocol UMCC 2007.123 (NCT01190527)

  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.

  6 weeks (30 treatments, 5 days per week)

Secondary Outcomes (2)

• Time to Local Progression

  Up to 60 months

• Overall Survival Time

  Up to 60 months

Study Arms (1)

Response-driven Adaptive RT

EXPERIMENTAL

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; Drug: Paclitaxel; Device: FDG-PET; Device: V/Q SPECT; Drug: Durvalumab

Interventions

Response-driven Adaptive Radiation Therapy RADIATION

Response-driven Adaptive RT

Carboplatin DRUG

AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV

Response-driven Adaptive RT

Paclitaxel DRUG

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

Response-driven Adaptive RT

FDG-PET DEVICE

Also known as: Positron Emission Tomography Scan

Response-driven Adaptive RT

V/Q SPECT DEVICE

Also known as: Single-photon Emission Computed Tomography Scan

Response-driven Adaptive RT

Durvalumab DRUG

10 mg/kg during consolidation. Given IV

Response-driven Adaptive RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Paclitaxel; Positron-Emission Tomography; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: ClinicalTrials.gov CC Admin
• Organization: University of Michigan Rogel Cancer Center

clinicaltrialsgov_ccadmin@med.umich.edu

734-936-9499

Study Officials

• Shruti Jolly, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 9, 2015
• Study Start: January 14, 2016
• Primary Completion: November 28, 2021
• Study Completion: April 21, 2022
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Locations

US (2)