The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02135679
• Collaborator: (none)
• Enrollment: 153
• Location: 1
• Duration (Months): 124
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

CTC levels collected pre-surgery will be correlated with pathological samples.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Radiation: Radiotherapy

Detailed Description

Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore & describe the pattern of CTC detection in all patients

Study Design

• Study Type: Observational
• Actual Enrollment: 153 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Patients with early stage NSCLC undergoing stereotactic radiotherapy	Radiation: Radiotherapy
Cohort 2 Patients with locally advanced NSCLC undergoing standard chemoradiotherapy	Radiation: Radiotherapy
Cohort 3 Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone	Radiation: Radiotherapy
Cohort 4 Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir.	Radiation: Radiotherapy
Cohort 5 Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy	Radiation: Radiotherapy
Cohort 6 (Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy)	Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

1. Circulating tumor cells will be detected by imaging for green fluorescent protein (GFP) which measures cells which high levels of telomerase activity after adenovirus transduction. CTCs are measured in units of number of GFP-positive cells /mL. [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.

• Age 18 or older

• Signed informed consent

• Patients who are incapable of providing informed consent are excluded from participating in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Samuel Swisher McClure, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02135679
• Other Study ID Numbers: UPCC 12512
• First Posted: May 12, 2014
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating

Study Results

No Results Posted as of Apr 1, 2022