Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

NCT01525446 | Terminated Early Phase 1 DMC

• 1 other identifier: 11-021
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue. In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Feasibility and safety

  To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

  2 years

• Safety and tolerability

  Frequency of radiation pneumonitis in participants treated with proton radiation

  2 years

Secondary Outcomes (4)

• Toxicity

  2 years

• Efficacy

  2 years

• Disease Free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

SBRT with proton beam radiation

EXPERIMENTAL

4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of \> 3 cm)

Radiation: SBRT with proton beam radiation

Interventions

SBRT with proton beam radiation RADIATION

4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of \> 3 cm)

SBRT with proton beam radiation

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed)
• Stage clinical T1 N0 M0 or T2 N0 M0
• NSCLC must be limited to a single lesion
• NSCLC must be peripherally located (\> 2 cm from proximal bronchial tree and \> 1 cm from mediastinal pleura)
• NSCLC must be considered medically inoperable
• Life expectancy greater than 6 months

You may not qualify if:

• Pregnant or breastfeeding
• Prior radiation therapy to the lungs or mediastinum
• Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated
• Receiving other study agents or other types of cancer therapy
• Uncontrolled intercurrent illness
• Pacemaker or defibrillator-dependent

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial 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

Study Officials

• Henning Willers, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Radiation Oncologist

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: February 3, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 17, 2016

Record last verified: 2016-02

Locations

US (1)