Trial Outcomes & Findings for High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer (NCT NCT03870529)
NCT ID: NCT03870529
Last Updated: 2024-01-09
Results Overview
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
TERMINATED
EARLY_PHASE1
20 participants
Up to 2 years
2024-01-09
Participant Flow
Participant milestones
| Measure |
Vitamin A Compound
Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.
Vitamin A Compound: Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection
|
Therapeutic Conventional Surgery
Description Participants undergo surgical resection.
Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Vitamin A Compound
n=11 Participants
Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.
Vitamin A Compound: Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection
|
Therapeutic Conventional Surgery
n=9 Participants
Description Participants undergo surgical resection.
Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
69.1 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
67.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
Measurement of GCs per unit area in adjacent lymph nodes will be assessed using semi-quantitative designation (Score of high, moderate, low, or absent) in patients who receive neoadjuvant vitamin A and controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
Pathologic response will be defined by tumor necrosis which will be dichotomized as present or absent in patients who receive neoadjuvant vitamin A and controls
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures
Overall survival of patients receiving neoadjuvant Vitamin A and in controls.
Outcome measures
Outcome data not reported
Adverse Events
Vitamin A Compound
Therapeutic Conventional Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Coordinator
Wake Forest Baptist Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place