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: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/22/2018 |
| Start Date: | March 23, 2011 |
| End Date: | May 1, 2020 |
Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
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
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
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with
stage II-III NSCLC.
SECONDARY OBJECTIVES:
I. To determine the dose-limiting toxicity, if the MTD is reached.
II. To determine the tumor local control (LC).
III. To determine the lung cancer disease specific survival (DSS).
IV. To determine the overall survival (OS).
V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels
as predictive biomarkers for treatment induced tissue injury.
OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.
Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks
followed by 5 fractions of hypofractionated RT boost. Patients also receive standard
carboplatin and paclitaxel for 3 weeks.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months
for the first 2 years, and then periodically thereafter.
I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with
stage II-III NSCLC.
SECONDARY OBJECTIVES:
I. To determine the dose-limiting toxicity, if the MTD is reached.
II. To determine the tumor local control (LC).
III. To determine the lung cancer disease specific survival (DSS).
IV. To determine the overall survival (OS).
V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels
as predictive biomarkers for treatment induced tissue injury.
OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.
Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks
followed by 5 fractions of hypofractionated RT boost. Patients also receive standard
carboplatin and paclitaxel for 3 weeks.
After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months
for the first 2 years, and then periodically thereafter.
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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Percy P. Lee
Phone: 310-825-9771
Click here to add this to my saved trials
