Implantation of Markers for the Radiotherapy of Lung Cancer Patients

NCT00856427 | Terminated Phase 1 DMC

• 4 other identifiers: MCC-11284HM11284CDR0000630623NCI-2013-00512
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; stage IIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (6)

• Number of dropped markers

  up to 5 years

• Marker misplacements

  up to 5 years

• Implantation-related side effects

  up to 5 years

• Visibility of markers on CT and x-rays

  up to 5 years

• Positional reliability of markers

  Up to 5 years

• Usability for patient treatment

  up to 5 years

Study Arms (1)

Diagnostic

EXPERIMENTAL

Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors).

Radiation: radiation therapy treatment planning/simulation; Procedure: implanted fiducial-based imaging

Interventions

radiation therapy treatment planning/simulation RADIATION

Undergo implantation of radio-opaque markers

Diagnostic

implanted fiducial-based imaging PROCEDURE

Undergo implantation of radio-opaque markers

Diagnostic

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of non-small cell lung cancer * Stage I-IIIB disease * No prior surgical tumor resection * Respiration-induced tumor motion \> 5 mm * Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals PATIENT CHARACTERISTICS: * Not pregnant * No insufficient lung function or other parameters prohibiting a bronchoscopy * Not a prisoner or institutionalized PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent chemotherapy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Elisabeth Weiss, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

US (1)