Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer

NCT01657617 | Completed Results DMC FDA Device

• 1 other identifier: MCC-07-RAD-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a significant problem. Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs. Mounting evidence supports the use of hypofractionated stereotactically delivered radiation therapy to control lung cancer with acceptable toxicity profiles. Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED \> 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in 180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy, 59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses, achieving a minimum cumulative BED of approximately 110Gy-equivalent.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Boost Dose Toxicity

  Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.

  Up to 5 years

Secondary Outcomes (1)

• Primary Tumor Relapse Following SBRT

  Up to 5 years

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Boost Stereotactic Body Radiation Therapy (SBRT)

Radiation: Boost Stereotactic Body Radiation Therapy

Interventions

Boost Stereotactic Body Radiation Therapy RADIATION

The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with: Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy. Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.

Radiation Therapy

Eligibility Criteria

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

You may qualify if:

• Histological confirmation of non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchoalveolar cell carcinoma, or non-small cell carcinoma NOS) by either biopsy or cytology.
• Clinical AJCC stage IIA (T1N1M0), IIB (T2,N1M0, T3,N0,M0) or IIIA (T1-3, N1-2,M0)/selected IIIB. In all cases, patients may be included at the discretion of the treating radiation oncologist if it will be likely the disease can be encompassed by the stereotactic boost will be included.
• Patients with non-bulky (\< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy determined by pre-treatment CT scan, PET or mediastinoscopy
• Must have completed a standard course of chemoradiation in accordance with NCCN Guidelines
• One month following definitive chemoradiation, CT or PET-CT revealing limited volume residual disease within the site of primary tumour mass (post-chemo/RT mass \</= 7.0 cm). Patients with a CR and no obvious target are not eligible.
• must be able to fit into the Elekta Stereotactic body frame
• Patients must be ≥ 18 years of age.
• The patient's ECOG performance status must be 0-2.
• Women of childbearing potential and male participants must use an effective contraceptive method.
• Patients must sign a study-specific consent form.

You may not qualify if:

• Any other active cancer OR No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for 5 years.
• Plans for the patient to receive other concomitant antineoplastic therapy while on this protocol, except at disease progression. Patients may be allowed to use bisphosphonates for hypercalcemia.
• Pregnant or lactating women

Sponsors & Collaborators

• Ronald McGarry: lead

Study Sites (1)

Markey Cancer Center

Lexington, Kentucky, 40536, 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

Limitations and Caveats

This study was a single site, low enrollment proof of concept trial of the effectiveness of local radiation following SOC chemotherapy. The data are promising; however, larger trials are in order to demonstrate its full therapeutic value.

Results Point of Contact

• Title: Ronald McGarry
• Organization: University of Kentucky

rcmcga2@email.uky.edu

859 323 6486

Study Officials

• Ronald C. McGarry, MD, PhD.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Radiation Medicine

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: August 6, 2012
• Study Start: October 1, 2007
• Primary Completion: June 5, 2014
• Study Completion: July 9, 2018
• Last Updated: October 5, 2018
• Results First Posted: October 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)