Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

NCT01899989 | Completed Phase 1

• 1 other identifier: 13-113
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to determine if the use of exploratory immunologic biomarkers, functional MRI images can serve as early predictors for response of NSCLC. It also will provide important information on the perceived side effects from a patient perspective. Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which chemotherapy is not part of the standard of care). Patients will only receive stereotactic body radiation therapy (SBRT) per standard dose guidelines.

Conditions

Non-small Cell Lung Cancer

Keywords

Stereotactic Body Radiation Therapy (SBRT); Chemotherapy; 13-113

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose (Cohort A)

  standard 3+3 dose-escalation scheme

  2 years

Secondary Outcomes (2)

• ≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)

  ≥3 months post SBRT

• overall survival (Cohorts A & B)

  2 years

Study Arms (2)

A) >5cm,Chemo eligible (closed to accrual)

EXPERIMENTAL

Patients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.

Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: cisplatin or carboplatin-based

B) 3-5cm OR Chemo ineligible

EXPERIMENTAL

Using intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in \< 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in \< 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

A) >5cm,Chemo eligible (closed to accrual); B) 3-5cm OR Chemo ineligible

cisplatin or carboplatin-based DRUG

Standard chemotherapy with a histology-selected cisplatin or carboplatin-based doublet will be administered intravenously as adjuvant therapy. Gemcitabine will be used for squamous cell carcinomas and pemetrexed will be used for non-squamous non-small cell lung cancer. Cisplatin or carboplatin will be used in combination with the histology-selected agent. The choice of cisplatin or carboplatin will be at the discretion of the treating medical oncologist.

A) >5cm,Chemo eligible (closed to accrual)

Eligibility Criteria

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

You may qualify if:

• All patients:
• Histologically confirmed non-small cell lung cancer
• Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection
• Age ≥ 18 years
• Women of childbearing potential must have a negative blood pregnancy test
• Ability to provide written informed consent
• Cohort A:
• Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) Selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the PI if all normal tissue guidelines can be met
• Eligible for chemo-therapy
• Karnofsky Performance Status ≥70%
• Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
• Patients must show adequate organ function as defined by:
• Calculated creatinine clearance ≥40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault)
• Calculated creatinine clearance ≥30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease)
• AST and ALT less than 3 x ULN

You may not qualify if:

• All patients:
• Prior radiation therapy to the lungs
• Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable. Recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment.)
• N2-3 lymph node involvement based on PET/EBUS-FNA/mediastinoscopy (Any N2 disease that is more than just minimal single station involvement is excluded)
• Direct tumor extension into including aorta or pulmonary artery
• Chronic corticosteroid use equivalent to ≥ prednisone 10 mg daily
• Prior treatment with a CD137 agonist, ipilimumab, or the CTLA-4 inhibitor, or PD-1/PDL-1 inhibitor
• Unstable congestive heart failure
• Cohort A:
• Continuous oxygen use
• Pacemaker and defibrillators are excluded
• Stents etc. will be evaluated according to MSKCC policy
• Unmanageable claustrophobia
• High risk for nephrogenic systemic fibrosis

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering at Mercy Medical Center

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Cisplatin

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Abraham Wu, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 16, 2013
• Study Start: July 5, 2013
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

US (8)