Trial Outcomes & Findings for Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET (NCT NCT01065818)

NCT ID: NCT01065818

Last Updated: 2017-09-26

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 2.5 months
• Results posted on: 2017-09-26

Participant Flow

Participant milestones

Measure	Fluoro-L-Thymidine Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine (FLT): 4-dimensional (4D)-Positron Emission Tomography (PET)/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Fluoro-L-Thymidine Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine (FLT): 4-dimensional (4D)-Positron Emission Tomography (PET)/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery.
Overall Study Withdrawal by Subject	1
Overall Study Not a candidate for surgery	1

Baseline Characteristics

Early Prediction of Pathology Response of Chemoradiotherapy With FLT PET

Baseline characteristics by cohort

Measure	Fluoro-L-Thymidine n=6 Participants Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Data on age (per age categories) and race/ethnicity was not available for these 6 subjects. Only sex was available.
Age, Customized >18 years	6 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2.5 months

Population: Due to poor enrollment, data was not analyzed. Adequate data was not collected and the only type of data that remained available was the total # enrolled, some information of the population demographics, and AE/SAE logs that were submitted to the IRB for review.

Outcome measures

Outcome data not reported

Adverse Events

Fluoro-L-Thymidine

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluoro-L-Thymidine n=5 participants at risk Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study.
General disorders Allergic Reaction to Chemotherapy	20.0% 1/5 • Number of events 1
General disorders Chest Pain	20.0% 1/5 • Number of events 1
Hepatobiliary disorders Abnormal Liver Function	20.0% 1/5 • Number of events 1

Other adverse events

Measure	Fluoro-L-Thymidine n=5 participants at risk Injection pre-Neoadjuvant Therapy (CRT, CT, or RT) and post-3 weeks Neoadjuvant Therapy (CRT, CT, RT)(3 weeks from the start of Neoadjuvant Therapy) prior to surgery. Fluoro-L-Thymidine: 4D-PET/CT imaging with an injection of Fluoro-L-Thymidine at pre-Neoadjuvant Therapy and post-3 weeks Neoadjuvant Therapy prior to surgery. Only 5 subjects were followed for AEs/SAEs since one subject withdrew consent prior to any participation in the study.
Blood and lymphatic system disorders Abnormal Complete Blood Count (CBC)	20.0% 1/5 • Number of events 1
Endocrine disorders Blood Glucose Level Increased	20.0% 1/5 • Number of events 1
Hepatobiliary disorders ALT Increased	20.0% 1/5 • Number of events 1
Ear and labyrinth disorders Odynophagia	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders White Blood Cell (WBC) Count Increased	20.0% 1/5 • Number of events 1

Additional Information

K.S. Clifford Chao, MD

Columbia University

Phone: 212-305-9987

Email: ksc2119@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place