Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients

NCT01757158 | Withdrawn

• 1 other identifier: 0908010555
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary curative treatment of lung cancer patients is surgery, chemotherapy and/or radiation therapy (either or all depending on the extent of disease). Surgical resection usually requires removal of a lobe of the lung (lobectomy). There are, however, some patients who are unable to have a lobectomy. There are several reasons why a patient should not have a lobectomy including prior operations in the same area of the lung or poor lung functions. Sub-lobe operations (less than a full lobectomy), are alternatives for these patients. Types of sub-lobe operations include wedge resection or segmentectomy. However, a randomized trial in early stage lung cancer patients that compared lobectomy versus wedge resection showed worse local control of cancer with wedge resection. Therefore, localized disease wedge resection is considered an inadequate operation. This inadequacy can be compensated if radiation seeds are added to the site of wedge resection. Iodine-125 (I-125) is the most commonly used radiation seed for this purpose. I-125, however, unfortunately has a relatively long half life (time taken for activity to become half) of 2 months. Therefore, the patient is technically 'radioactive' for an average of 6 months to 1 year. This can seriously compromise quality of life. Cesium-131 is another radiation seed that may more effectively treat lung cancer patients. Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as compared to 180 days (6 months) with I-125. The objective of this study is the use Cs-131 radiation seeds in lung cancer patients who are planning to undergo a wedge resection for localized disease and follow the patients for cancer control and toxicity. These results will be compared to pre-existing data for I-125 treatment outcomes in lung cancer patients who have had a wedge resection for localized disease.

Conditions

Lung Cancer

Keywords

lung cancer; lobectomy; local recurrence

Outcome Measures

Primary Outcomes (1)

• Efficacy

  To assess local recurrence rate after a wedge resection and Cs-131 implant.

  5 years

Secondary Outcomes (1)

• Quality of Life

  pre-surgery, 3 months, 12 months, 24 months

Study Arms (1)

Cs-131 brachytherapy seeds

EXPERIMENTAL

sub-lobar resection plus cesium-131 brachytherapy

Radiation: Cs-131 brachytherapy seeds

Interventions

Cs-131 brachytherapy seeds RADIATION

Cesium-131 is another radiation seed that may more effectively treat lung cancer patients. Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as compared to 180 days (6 months) with I-125.

Also known as: Brachytherapy

Cs-131 brachytherapy seeds

Eligibility Criteria

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

You may qualify if:

• Patients must have suspicious lung nodule for clinical stage I/recurrent Lung Cancer
• Mass Tumor size \< 7 cm
• Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration.
• Patient must have ECOG/Zubrod performance status 0,1, or 2.
• Resected lung cancers with positive margins

You may not qualify if:

• Patient has already received high dose radiation to the area
• Cancerous nodule is very close to the esophagus or spinal chord, thereby increasing the risk of radiation treatment
• Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, etc.)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• IsoRay Medical, Inc.: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Bhupesh Parashar, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: December 28, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2018
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)