Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
18 Years
N/A
Both
Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Trial Information
Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.
Outcome Description:
The primary end point is to reach the maximum tolerated dose or a total of 75 Gy, whichever comes first, by escalating the daily dose of last 5 fractions.
Outcome Time Frame:
up to 90 days
Safety Issue:
Yes
Principal Investigator
Percy Lee
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
10-001342
NCT ID:
NCT01345851
Start Date:
March 2011
Completion Date:
Related Keywords:
- Adenocarcinoma of the Lung
- Adenosquamous Cell Lung Cancer
- Large Cell Lung Cancer
- Recurrent Non-Small Cell Lung Cancer
- Squamous Cell Lung Cancer
- Stage IIA Non-small Cell Lung Cancer
- Stage IIB Non-small Cell Lung Cancer
- Stage IIIA Non-Small Cell Lung Cancer
- Stage IIIB Non-Small Cell Lung Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles, California 90095 |
