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

NCT01345851 | Active Not Recruiting DMC

• 2 other identifiers: 10-001342NCI-2011-00673
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.

  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 Outcomes (3)

• To determine tumor Local control

  participants will be followed for 2 years

• To determine Lung cancer Disease specific survival

  Participants will be followed for 2 years

• Overall survival

  Participants will be followed for 2 years

Study Arms (1)

Treatment (dose-escalation of RT)

EXPERIMENTAL

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

Interventions

hypofractionated radiation therapy RADIATION

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

Treatment (dose-escalation of RT)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (dose-escalation of RT)

image-guided radiation therapy RADIATION

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

Treatment (dose-escalation of RT)

carboplatin DRUG

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

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (dose-escalation of RT)

paclitaxel DRUG

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

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (dose-escalation of RT)

stereotactic body radiation therapy RADIATION

Undergo hypofractionated RT

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (dose-escalation of RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 38206614 DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Image-Guided; Carboplatin; Paclitaxel; Taxes; Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Percy Lee

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: May 2, 2011
• Study Start: March 23, 2011
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 25, 2026

Record last verified: 2025-02

Locations

US (1)