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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01345851
First received: April 27, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
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
Radiation: hypofractionated radiation therapy
Other: laboratory biomarker analysis
Radiation: image-guided radiation therapy
Drug: carboplatin
Drug: paclitaxel
Radiation: stereotactic body radiation therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer. [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To determine tumor Local control [ Time Frame: participants will be followed for 2 years ] [ Designated as safety issue: No ]
    Radiological evaluation (CT, PET-CT) will be done to assess tumor.

  • To determine Lung cancer Disease specific survival [ Time Frame: Participants will be followed for 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Participants will be followed for 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (dose-escalation of 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.
Radiation: hypofractionated radiation therapy
Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
Other: laboratory biomarker analysis
Correlative studies
Radiation: image-guided radiation therapy
Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.
Drug: carboplatin
The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Radiation: stereotactic body radiation therapy
Undergo hypofractionated RT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345851

Locations
United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Percy P. Lee    310-825-9771      
Principal Investigator: Percy P. Lee         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Percy Lee Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01345851     History of Changes
Other Study ID Numbers: 10-001342, NCI-2011-00673
Study First Received: April 27, 2011
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014