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Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

Primary Purpose

Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Contrast Agent

About this trial

This is an interventional supportive care trial for Locally Advanced Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and marrow laboratory values for radiation therapy deemed by appropriate the investigator obtained within 14 days prior to registration for protocol therapy
Women of childbearing potential (WOCBP) must obtain a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at day -30 to day 0
Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception during the time of the study period
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year

Exclusion Criteria:

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Active central nervous system (CNS) metastases (if symptomatic or without prior brain imaging, subjects must undergo a head computed tomography [CT] scan or brain magnetic resonance imaging [MRI] within 28 days prior to registration for protocol therapy to exclude brain metastases)
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy
Active second cancers
History of psychiatric illness or social situations that would limit compliance with study requirements

Sites / Locations

Rutgers Cancer Institute of New JerseyRecruiting
RWJBarnabas Health - Robert Wood Johnson University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (CT simulation, contrast agent)

Arm Description

Patients undergo CT stimulation with or without IV contrast over 1.5 hours on days -15 to -1, then undergo SOC chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29.

Outcomes

Primary Outcome Measures

Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates

Will be analyzed using a one-sided z-test to determine if reduction in radiation doses to organs at risk compared will result in a lower rate of pneumonitis compared to historical controls.

Secondary Outcome Measures

Determine if adaptive radiation therapy reduces radiation doses to heart and lung

Will be compared to computed tomography simulation without adaptation of lung tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.

Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning

Will be compared to computed tomography simulation without adaptation of tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.

Change in toxicities, including cardiac and esophageal toxicities

Will be compared to historical controls who have not undergo adaptive re-planning at specified time points using Common Terminology Criteria for Adverse Events version 5.0.

Toxicity correlation to disease-free survival (DFS)/progression-free survival (PFS)/overall survival (OS)

Will determine if toxicity correlates to DFS/PFS/OS using historical controls for comparison, estimated via Kaplan-Meier product limit and compared among different toxicity levels using a log-rank test.

Tumor volume reduction

Will determine if tumor volume reduction correlates to immunotherapy response.

Full Information

NCT ID

NCT04751747

First Posted

December 23, 2020

Last Updated

July 11, 2023

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04751747

Brief Title

Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

Official Title

The Role of Adaptive Radiation Planning in Patients With Non-Small Cell Lung Cancer on Radiation Induced Toxicity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2021 (Actual)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial studies the effect of adaptive radiation planning in reducing side effects associated with radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer. Prior to radiation, patients undergo simulation, where they are positioned on the treatment table in a manner that can be reproduced each time they receive treatment in order to reach the tumor exactly at the same spot each time. However, a patient's tumor may shrink as they receive radiation, exposing healthy tissue to radiation as well. Adaptive radiation planning involves re-designing a treatment plan at set intervals. The purpose of this study is to see whether establishing set time points through adaptive radiation planning, regardless of whether the doctor notices a significant decrease in tumor size, will reduce some of the side effects associated with radiation treatment and immunotherapy.

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue, with the intention of establishing a new standard treatment modality. OUTLINE: Patients undergo computed tomography (CT) stimulation with or without intravenous (IV) contrast over 1.5 hours on days -15 to -1, then undergo standard of care (SOC) chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29. After completion of study, patients are followed up at 3-12 weeks, and then every 6 months for approximately 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Unresectable Lung Non-Small Cell Carcinoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supportive care (CT simulation, contrast agent)

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Intervention Description

Undergo CT simulation

Intervention Type

Other

Intervention Name(s)

Contrast Agent

Other Intervention Name(s)

Contrast, Contrast Drugs, contrast material, Contrast Medium

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates

Description

Will be analyzed using a one-sided z-test to determine if reduction in radiation doses to organs at risk compared will result in a lower rate of pneumonitis compared to historical controls.

Time Frame

At 6 months post chemoradiation

Secondary Outcome Measure Information:

Title

Determine if adaptive radiation therapy reduces radiation doses to heart and lung

Description

Time Frame

Baseline up to day 29 of treatment

Title

Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning

Description

Time Frame

Baseline up to day 29 of treatment

Title

Change in toxicities, including cardiac and esophageal toxicities

Description

Will be compared to historical controls who have not undergo adaptive re-planning at specified time points using Common Terminology Criteria for Adverse Events version 5.0.

Time Frame

Baseline up to 25 months after chemoradiation

Title

Toxicity correlation to disease-free survival (DFS)/progression-free survival (PFS)/overall survival (OS)

Description

Time Frame

Up to 25 months after chemoradiation

Title

Tumor volume reduction

Description

Will determine if tumor volume reduction correlates to immunotherapy response.

Time Frame

Up to 25 months after chemoradiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ and marrow laboratory values for radiation therapy deemed by appropriate the investigator obtained within 14 days prior to registration for protocol therapy Women of childbearing potential (WOCBP) must obtain a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at day -30 to day 0 Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception during the time of the study period Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Exclusion Criteria: History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial Active central nervous system (CNS) metastases (if symptomatic or without prior brain imaging, subjects must undergo a head computed tomography [CT] scan or brain magnetic resonance imaging [MRI] within 28 days prior to registration for protocol therapy to exclude brain metastases) Treatment with any investigational agent within 28 days prior to registration for protocol therapy Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy Active second cancers History of psychiatric illness or social situations that would limit compliance with study requirements

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salma K Jabbour

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salma K. Jabbour

Phone

732-253-3961

jabbousk@cinj.rutgers.edu

First Name & Middle Initial & Last Name & Degree

Salma K. Jabbour

Facility Name

RWJBarnabas Health - Robert Wood Johnson University Hospital

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Salma Jabbour, MD

Phone

732-253-3961

jabbousk@cinj.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

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