Overview

Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Status:
Active, not recruiting
Trial end date:
2022-05-01
Target enrollment:
0
Participant gender:
All
Summary
This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

- Histologically confirmed primary non-metastatic NSCLC; eligible histological subtypes
include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell
carcinoma, and non-small cell carcinoma not otherwise specified

- Clinical stage II and III NSCLC as defined by American Joint Committee on Cancer
(AJCC) Cancer Staging Manual, seventh edition; acceptable imaging modalities to
document nodal positivity include computed tomography (CT) chest, positron emission
tomography (PET)-CT, or thoracic magnetic resonance imaging (MRI)

- For clinically stage II patients, the patient must have been evaluated by a thoracic
surgeon, and deemed medically or technically inoperable, or the patient must refuse
surgery

- Karnofsky performance status >= 70

- If a woman is of childbearing potential, a negative serum pregnancy test must be
documented; women of childbearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control; or abstinence) for duration of study
treatment and for up to 4 weeks following the study treatment

Exclusion Criteria:

- Patients who have previously received therapeutic radiation therapy to the chest

- Active systemic, pulmonary, or pericardial infection

- Use of concurrent gemcitabine-based chemotherapy during radiotherapy

- Pregnant women, or women of childbearing potential who are sexually active and not
willing/able to use medically acceptable forms of contraception for the entire study
period and for up to 4 weeks after the study treatment

- Refusal to sign the informed consent

- Patients who are participating in a concurrent treatment protocol