Trial Title:
Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
NCT ID:
NCT06008730
Condition:
Resectable Lung Non-Small Cell Carcinoma
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Treatment (proton beam radiation therapy)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Radiation
Intervention name:
Proton Beam Radiation Therapy
Description:
Undergo proton beam radiation therapy
Arm group label:
Treatment (proton beam radiation therapy)
Other name:
External beam radiation therapy protons (procedure)
Other name:
External Beam Radiotherapy (protons)
Other name:
PBRT
Other name:
Proton
Other name:
Proton EBRT
Other name:
Proton External Beam Radiotherapy
Other name:
Proton Radiation Therapy
Other name:
PROTON Therapy
Other name:
Radiation, Proton Beam
Intervention type:
Other
Intervention name:
Radiology, Treatment Planning
Description:
Undergo radiation treatment planning
Arm group label:
Treatment (proton beam radiation therapy)
Summary:
This clinical trial tests proton beam radiation therapy in patients with non-small cell
lung cancer who have undergone surgical resection and have lymph nodes involving the
middle of the chest. Proton therapy is a type of radiation treatment that kills cancer
cells while avoiding surrounding healthy tissue. Proton beam therapy is sometimes used
after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton
beam radiation therapy may work better than conventional radiation treatment after
surgery in patients with non-small cell lung cancer.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small
cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
I. To measure the radiation dose to the circulating immune compartment and explore its
association with clinical endpoints.
II. To assess the efficacy of PBRT for resected N2 NSCLC.
OUTLINE:
Patients undergo radiation treatment planning and then undergo proton beam radiation
therapy on study. Patients also undergo collection of blood samples.
Patients are followed up for 24 months after first dose of radiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >= 18 years
- Patients must have undergone complete surgical resection after pre-operative
systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve
lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least
three mediastinal (N2) stations sampled
- Pathology report from surgical resection indicating complete resection of primary
tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node
(pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients
who have initially positive margins that are secondarily cleared on additional
margins will be eligible
- Eastern Cooperative Oncology Group Performance (ECOG) performance status =< 2
(Karnofsky >= 60%)
- Life expectancy > 12 weeks as determined by the investigator
- Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of simulation to meet
entry criteria) (within 28 days of cycle 1 day 1)
- White blood cell >= 2000/uL (after at least 7 days without growth factor support or
transfusion) (within 28 days of cycle 1 day 1)
- Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to
meet entry criteria) (within 28 days of cycle 1 day 1)
- Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28
days of cycle 1 day 1)
- Because radiotherapy is known to be teratogenic, female of child-bearing potential
(FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
- FCBP and men must agree to use adequate contraception (hormonal or barrier method of
birth control; abstinence) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while she
or her partner is participating in this study, she should inform her treating
physician immediately. Men treated or enrolled on this protocol must also agree to
use adequate contraception prior to the study, for the duration of study
participation, and 3 months after completion of radiotherapy. A female of
childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
for at least 24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months
- Completion of all previous therapy (including surgery, chemotherapy, or
investigational therapy) for the treatment of cancer >= 2 weeks before the start of
radiotherapy
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- Willingness and ability of the subject to comply with scheduled visits, drug
administration plan, protocol-specified laboratory tests, other study procedures,
and study restrictions
- Evidence of a personally signed informed consent indicating that the subject is
aware of the neoplastic nature of the disease and has been informed of the
procedures to be followed, the experimental nature of the therapy, alternatives,
potential risks and discomforts, potential benefits, and other pertinent aspects of
study participation
Exclusion Criteria:
- Patients who have stage IV disease
- Patients who have had systemic therapy less than 2 weeks prior to anticipated
radiotherapy start
- Patients who have received prior thoracic radiotherapy
- Patients who have a prior history of NSCLC (other than index diagnosis)
- Patients who have small cell lung cancer
- Patients whose tumors exhibit targetable alterations in EGFR or ALK
- Patients with incomplete surgical resection, including R1 (microscopic residual
disease) or R2 resection (macroscopic residual disease), sampling of fewer than
three mediastinal lymph node stations, unremoved positive lymph nodes, malignant
pleural effusion, or malignant pericardial effusion
- Patients who are receiving any other investigational agents or an investigational
device within 21 days before administration of first dose of study drugs
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
- Significant cardiovascular disease (eg, myocardial infarction, arterial
thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of
study therapy; angina requiring therapy; symptomatic peripheral vascular disease;
New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled
grade >= 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood
pressure >= 160 mmHg) despite antihypertensive therapy
- The following vulnerable populations will not be offered participation in this
study:
- Adults with cognitive impairment or unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Tegan VandenBosch
Email:
tegan.honor.vandenbosch@emory.edu
Investigator:
Last name:
William Stokes, MD
Email:
Principal Investigator
Start date:
November 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008730
