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

• ClinicalTrials.gov Identifier: NCT01656460
• Recruitment Status: Completed
• First Posted: August 3, 2012
• Results First Posted: July 24, 2015
• Last Update Posted: July 22, 2020
• Sponsor: Dr Thomas DiPetrillo
• Collaborator: Memorial Hospital of Rhode Island
• Information provided by (Responsible Party): Dr Thomas DiPetrillo, Brown University

Tracking Information

• First Submitted Date: July 24, 2012
• First Posted Date: August 3, 2012
• Results First Submitted Date: June 29, 2015
• Results First Posted Date: July 24, 2015
• Last Update Posted Date: July 22, 2020
• Study Start Date: April 2012
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2015)

Early and Intermediate Toxicity for Dose Limiting Toxicity [ Time Frame: 3 months ]

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.

Original Primary Outcome Measures (submitted: August 2, 2012)

to evaluate and report the rate of early and intermediate toxicity [ Time Frame: 3 months ]

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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
• Official Title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
• 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.
• Detailed Description: This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

• Radiation: Stereotactic radiation Arm 1

  Dose Levels Dose per Fraction Total Dose

  1 8 Gy 16 Gy

• Radiation: Stereotactic radiation Arm 2
  Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
• Radiation: Stereotactic radiation Arm 3
  Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
• Radiation: Stereotactic radiation Arm 4
  Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy

Study Arms

• Experimental: Stereotactic radiation Arm 1

  Dose Levels/total Dose

  1 16 Gy

  Intervention: Radiation: Stereotactic radiation Arm 1
• Experimental: Stereotactic radiation Arm 2
  2 20 Gy
  Intervention: Radiation: Stereotactic radiation Arm 2
• Experimental: Stereotactic radiation Arm 3
  3 24 Gy
  Intervention: Radiation: Stereotactic radiation Arm 3
• Experimental: Stereotactic radiation Arm 4
  4 28 Gy
  Intervention: Radiation: Stereotactic radiation Arm 4

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 29, 2015): 12
• Original Estimated Enrollment (submitted: August 2, 2012): 18
• Actual Study Completion Date: May 16, 2017
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01656460
• Other Study ID Numbers: BrUOG 259
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr Thomas DiPetrillo, Brown University
• Original Responsible Party: Debora G. Isdale, Brown University, Director of Operations
• Current Study Sponsor: Dr Thomas DiPetrillo
• Original Study Sponsor: Debora G. Isdale
• Collaborators: Memorial Hospital of Rhode Island

Investigators

• Study Chair: Howard Safran, MD; BrUOG Study Chair

• PRS Account: Brown University
• Verification Date: July 2020