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

NCT ID: NCT01345851

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-23
• Study Completion Date: 2027-01-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hypofractionated radiation therapy

Intervention Type: RADIATION

Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

image-guided radiation therapy

Intervention Type: RADIATION

Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.

carboplatin

Intervention Type: DRUG

The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.

paclitaxel

Intervention Type: DRUG

The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo hypofractionated RT

Interventions

hypofractionated radiation therapy

Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks

Intervention Type: RADIATION

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

image-guided radiation therapy

Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.

Intervention Type: RADIATION

carboplatin

The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.

Intervention Type: DRUG

paclitaxel

The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.

Intervention Type: DRUG

stereotactic body radiation therapy

Undergo hypofractionated RT

Intervention Type: RADIATION

Other Intervention Names

Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; Anzatax; Asotax; TAX; Taxol; SBRT; stereotactic radiation therapy; stereotactic radiotherapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Percy Lee

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

References

Wu TC, Luterstein E, Neilsen BK, Goldman JW, Garon EB, Lee JM, Felix C, Cao M, Tenn SE, Low DA, Kupelian PA, Steinberg ML, Lee P. Accelerated Hypofractionated Chemoradiation Followed by Stereotactic Ablative Radiotherapy Boost for Locally Advanced, Unresectable Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Mar 1;10(3):352-359. doi: 10.1001/jamaoncol.2023.6033.

Reference Type: DERIVED

PMID: 38206614 (View on PubMed)

Other Identifiers

NCI-2011-00673

Identifier Type: REGISTRY

Identifier Source: secondary_id

10-001342

Identifier Type: -

Identifier Source: org_study_id