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

February 23, 2026 updated by: Jonsson Comprehensive Cancer Center

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: laboratory biomarker analysis
Correlative studies
Radiation: hypofractionated radiation therapy
Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
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
  • Paraplatin
  • Paraplat
Drug: paclitaxel
The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • TAX
Radiation: stereotactic body radiation therapy
Undergo hypofractionated RT
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine tumor Local control
Time Frame: participants will be followed for 2 years
Radiological evaluation (CT, PET-CT) will be done to assess tumor.
participants will be followed for 2 years
To determine Lung cancer Disease specific survival
Time Frame: Participants will be followed for 2 years
Participants will be followed for 2 years
Overall survival
Time Frame: Participants will be followed for 2 years
Participants will be followed for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Percy Lee, Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2011

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimated)

May 2, 2011

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-001342
  • NCI-2011-00673 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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