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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
Dr Thomas DiPetrillo, Brown University
ClinicalTrials.gov Identifier:
NCT01656460
First received: July 24, 2012
Last updated: July 25, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: Stereotactic radiation Arm 1
Radiation: Stereotactic radiation Arm 2
Radiation: Stereotactic radiation Arm 3
Radiation: Stereotactic radiation Arm 4
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Early and Intermediate Toxicity for Dose Limiting Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 12
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiation Arm 1

Dose Levels/total Dose

1 16 Gy

Radiation: Stereotactic radiation Arm 1

Dose Levels Dose per Fraction Total Dose

1 8 Gy 16 Gy

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PATIENT ELIGIBILITY Conditions for Patient Eligibility

  • 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

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656460

Locations
United States, Rhode Island
memorial Hospital of Rhode island
Pawtucket, Rhode Island, United States, 02860
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Dr Thomas DiPetrillo
Memorial Hospital of Rhode Island
  More Information

No publications provided

Responsible Party: Dr Thomas DiPetrillo, Prinicipal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01656460     History of Changes
Other Study ID Numbers: BrUOG 259
Study First Received: July 24, 2012
Results First Received: June 29, 2015
Last Updated: July 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Brown University:
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on September 02, 2015