Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

NCT01656460 | Completed Results DMC

• 1 other identifier: BrUOG 259
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Early and Intermediate Toxicity for Dose Limiting Toxicity

  Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.

  3 months

Study Arms (4)

Stereotactic radiation Arm 1

EXPERIMENTAL

Dose Levels/total Dose 1 16 Gy

Radiation: Stereotactic radiation Arm 1

Stereotactic radiation Arm 2

EXPERIMENTAL

2 20 Gy

Radiation: Stereotactic radiation Arm 2

Stereotactic radiation Arm 3

EXPERIMENTAL

3 24 Gy

Radiation: Stereotactic radiation Arm 3

Stereotactic radiation Arm 4

EXPERIMENTAL

4 28 Gy

Radiation: Stereotactic radiation Arm 4

Interventions

Stereotactic radiation Arm 1 RADIATION

Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy

Stereotactic radiation Arm 1

Stereotactic radiation Arm 2 RADIATION

Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy

Stereotactic radiation Arm 2

Stereotactic radiation Arm 3 RADIATION

Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy

Stereotactic radiation Arm 3

Stereotactic radiation Arm 4 RADIATION

Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

Stereotactic radiation Arm 4

Eligibility Criteria

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

PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion) * Pathologically or cytologically confirmed NSCLC * Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible. * Concurrent chemoradiation to a radiation dose of 50.4 Gy. * residual tumor volume after concurrent chemoradiation that is appropriate for SBRT: * Primary tumor \<120cc (approximately 6cm diameter). * Mediastinal/Hilar disease: 1-2 involved regions \<60cc (approximately 5cmx3cmx3cm) * Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL. * Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN. * ECOG performance status 0 to 2 * Minimum life expectancy of 12 weeks. * Age older than 18 years. * Voluntary, signed written informed consent. * Women of childbearing potential must have a negative pregnancy test * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter. Conditions for Patient Ineligibility (Exclusion) * Disease progression during or after standard chemoradiation to 50.4 Gy * Prior thoracic radiation other than the pre-operative radiation not greater than 50.4 * Metastatic disease * Uncontrolled severe, intercurrent illness. * Women who are breast-feeding. * No chemotherapy within 2 weeks from the first SBRT treatment. * Concurrent anticancer therapy. * Prior complete resection of all NSCLC.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dr Thomas DiPetrillo: lead
• Memorial Hospital of Rhode Island: collaborator

Study Sites (2)

memorial Hospital of Rhode island

Pawtucket, Rhode Island, 02860, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Thomas DiPetrillo, MD
• Organization: Brown University Oncology Research Group (BrUOG)

kayla_rosati@brown.edu

4018633000

Study Officials

• Howard Safran, MD

  BrUOG Study Chair

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 3, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: May 16, 2017
• Last Updated: July 22, 2020
• Results First Posted: July 24, 2015

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)