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

The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02135679
Enrollment
204
Registered
2014-05-12
Start date
2012-09-30
Completion date
2021-12-31
Last updated
2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

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

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

Interventions

RADIATIONRadiotherapy

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum24 monthsThe pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cohort 1
Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy
52
Cohort 2
Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy
69
Cohort 3
Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy
2
Cohort 4
Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy
0
Cohort 5
Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy
18
Cohort 6
Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy
63
Cohort 7
Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy
0
Total204

Baseline characteristics

CharacteristicCohort 2Cohort 3Cohort 4Cohort 1Cohort 5Cohort 6Cohort 7Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
45 Participants1 Participants0 Participants44 Participants8 Participants50 Participants0 Participants148 Participants
Age, Categorical
Between 18 and 65 years
24 Participants1 Participants0 Participants8 Participants10 Participants13 Participants0 Participants56 Participants
Age, Continuous66 years68 years—75 years63.5 years70 years—69 years
Biopsy-Proven Non-Small Cell Lung Cancer69 Participants2 Participants0 Participants52 Participants18 Participants0 Participants0 Participants141 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants2 Participants1 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
Black or African American
14 Participants0 Participants0 Participants10 Participants2 Participants12 Participants0 Participants38 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants3 Participants
Race (NIH/OMB)
White
53 Participants2 Participants0 Participants39 Participants15 Participants49 Participants0 Participants158 Participants
Region of Enrollment
United States
69 Participants2 Participants0 Participants52 Participants18 Participants63 Participants0 Participants204 Participants
Sex: Female, Male
Female
35 Participants2 Participants0 Participants31 Participants6 Participants33 Participants0 Participants107 Participants
Sex: Female, Male
Male
34 Participants0 Participants0 Participants21 Participants12 Participants30 Participants0 Participants97 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum

The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.

Time frame: 24 months

Population: There were no enrolled patients in Cohorts 4 and 7. The Overall Number of Participants Analyzed in the Arms/Groups is not consistent with numbers provided in the Participant Flow module because not all patients underwent sequential (multiple) assays necessary for analysis. Only 114 out of 204 patients fulfilled the analysis criteria such as sequential PET/CT scans performed in the home institution.

ArmMeasureGroupValue (MEDIAN)
Cohort 1To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL before definitive radiotherapy.3.9 CTCs/mL
Cohort 1To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL after definitive radiotherapy.0.4 CTCs/mL
Cohort 2To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL before definitive radiotherapy.9.1 CTCs/mL
Cohort 2To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL after definitive radiotherapy.0.6 CTCs/mL
Cohort 3To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL before definitive radiotherapy.9.1 CTCs/mL
Cohort 3To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL after definitive radiotherapy.0.6 CTCs/mL
Cohort 5To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL after definitive radiotherapy.0.6 CTCs/mL
Cohort 5To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL before definitive radiotherapy.9.1 CTCs/mL
Cohort 6To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL before definitive radiotherapy.3.9 CTCs/mL
Cohort 6To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment StratumCTC counts per mL after definitive radiotherapy.0.4 CTCs/mL

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026