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Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
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

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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 CenterLos Angeles, California  90095