An Alternative Radiation Fractionation Strategy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT01711697 | Unknown Phase 1 DMC

• 3 other identifiers: IRB00056552NCI-2012-01934RAD2179-12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

This phase I trial studies the best dose of radiation therapy in treating patients with locally advanced non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy, such as stereotactic body radiation therapy (SBRT), that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. SBRT has been shown to provide excellent results when used in early stage lung cancer, but has not yet been applied to patients with more advanced disease.

Conditions

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 (3)

• Maximum tolerated dose (MTD) defined to be the dose level that results in a probability equal to 0.33 that a dose limiting toxicity (DLT) will be manifest using Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.4)

  Up to 1 year

• Acute toxicities associated with this regimen using CTCAE v.4

  Crude rates of grade 3 and greater acute toxicities will be reported.

  Up to 90 days

• Late toxicities associated with this regimen using CTCAE v.4

  Crude rates of grade 3 and greater late toxicities will be reported.

  After 90 days

Secondary Outcomes (6)

• Local control

  Up to 5 years

• Distant metastasis

  Up to 5 years

• Patterns of failure

  Up to 5 years

• Overall survival

  At 1 year

• Overall survival

  At 2 years

Study Arms (1)

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

EXPERIMENTAL

Patients undergo radiation therapy daily and receive carboplatin and paclitaxel weekly for 4.5 weeks. Patients then undergo 2 boost SBRT treatments 2-3 days apart.

Radiation: stereotactic body radiation therapy; Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

Undergo SBRT

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

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

carboplatin DRUG

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

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

paclitaxel DRUG

Also known as: Anzatax, Asotax, TAX, Taxol

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (radiation therapy, carboplatin, paclitaxel, SBRT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven NSCLC, within 8 weeks prior to patient registration
• Unresectable disease
• Clinical stage Tx, T1-T4, N1-3, M0
• Karnofsky performance status (KPS) ≥ 70
• Pretreatment positron emission tomography (PET) CT scan to rule out metastatic disease
• The primary tumor may not be larger than 8 cm in maximum dimension
• If the primary tumor is central in location, defined as within 2 cm from the tracheobronchial tree, it must be no larger than 5 cm
• Mediastinal and hilar lymphadenopathy can be no larger than 5 cm at any nodal station
• Pretreatment brain CT with contrast or brain MRI to rule out metastases
• Pathologic assessment of the mediastinum to document involved nodal stations

You may not qualify if:

• Prior history of lung cancer
• Pregnancy
• Prior history of radiation to the chest

Sponsors & Collaborators

• Emory University: lead
• Washington University Siteman Cancer Center: collaborator

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Siteman Cancer Center - Washington University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Carboplatin; Paclitaxel; Taxes; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristin Higgins, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: September 4, 2012
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

US (4)