Trial Outcomes & Findings for The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy (NCT NCT02135679)

Last Updated: 2024-11-20

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

204 participants

Primary outcome timeframe

24 months

Results posted on

2024-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy	Cohort 2 Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy	Cohort 3 Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy	Cohort 5 Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy	Cohort 6 Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy
Overall Study STARTED	52	69	2	18	63
Overall Study COMPLETED	39	51	1	16	57
Overall Study NOT COMPLETED	13	18	1	2	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=52 Participants Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy	Cohort 2 n=69 Participants Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy	Cohort 3 n=2 Participants Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy	Cohort 4 Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy	Cohort 5 n=18 Participants Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy	Cohort 6 n=63 Participants Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy	Cohort 7 Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy	Total n=204 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	24 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants	13 Participants n=8 Participants	0 Participants n=8 Participants	56 Participants n=24 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	45 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants	50 Participants n=8 Participants	0 Participants n=8 Participants	148 Participants n=24 Participants
Age, Continuous	75 years n=5 Participants	66 years n=7 Participants	68 years n=5 Participants	—	63.5 years n=21 Participants	70 years n=8 Participants	—	69 years n=24 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	35 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	33 Participants n=8 Participants	0 Participants n=8 Participants	107 Participants n=24 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	34 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	12 Participants n=21 Participants	30 Participants n=8 Participants	0 Participants n=8 Participants	97 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	14 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	12 Participants n=8 Participants	0 Participants n=8 Participants	38 Participants n=24 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants	53 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	15 Participants n=21 Participants	49 Participants n=8 Participants	0 Participants n=8 Participants	158 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants
Region of Enrollment United States	52 Participants n=5 Participants	69 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants	63 Participants n=8 Participants	0 Participants n=8 Participants	204 Participants n=24 Participants
Biopsy-Proven Non-Small Cell Lung Cancer	52 Participants n=5 Participants	69 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	141 Participants n=24 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Cohort 1 n=21 Participants Patients with early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy	Cohort 2 n=50 Participants Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Radiotherapy	Cohort 3 n=2 Participants Patients with stage I-III NSCLC undergoing fractionated radiotherapy alone Radiotherapy	Cohort 4 Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the signal transduction inhibitor, nelfianvir Radiotherapy	Cohort 5 n=6 Participants Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Radiotherapy	Cohort 6 n=35 Participants Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Radiotherapy	Cohort 7 Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum CTC counts per mL before definitive radiotherapy.	3.9 CTCs/mL Interval 0.0 to 209.0	9.1 CTCs/mL Interval 0.57 to 570.7	9.1 CTCs/mL Interval 0.57 to 570.7	—	9.1 CTCs/mL Interval 0.57 to 570.7	3.9 CTCs/mL Interval 0.0 to 209.0	—
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum CTC counts per mL after definitive radiotherapy.	0.4 CTCs/mL Interval 0.0 to 5.5	0.6 CTCs/mL Interval 0.0 to 1.8	0.6 CTCs/mL Interval 0.0 to 1.8	—	0.6 CTCs/mL Interval 0.0 to 1.8	0.4 CTCs/mL Interval 0.0 to 5.5	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ching Lai

University of Pennsylvania

Phone: 267-250-9244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place