Trial Outcomes & Findings for Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer (NCT NCT00414271)

NCT ID: NCT00414271

Last Updated: 2019-07-25

Results Overview

Number of participants who completed neoadjuvant chemotherapy and underwent repeat CT and endoscopic ultrasound (EUS) with pathological complete response (pCR), partial response in the primary tumor, stable disease or progressive disease as defined by EUS criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: up to 5 years
• Results posted on: 2019-07-25

Participant Flow

Participant milestones

Measure	Docetaxel and Capecitabine in Gastric Cancer Intravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neo-adjuvant Chemotherapy in Locally Advanced Gastric Cancer

Baseline characteristics by cohort

Measure	Docetaxel and Capecitabine in Gastric Cancer n=18 Participants Intravenous docetaxel 60 mg/m2 on day 1 and oral capecitabine 900 mg/m2 two times per day from day 1 to day 14 every 3 weeks for 2 cycles.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Singapore	18 Participants n=5 Participants
locally advanced gastric cancer	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: Only 15 of the participants who completed neoadjuvant chemotherapy and underwent repeat CT and EUS had measurable tumors by both imaging methods.

Number of participants who completed neoadjuvant chemotherapy and underwent repeat CT and endoscopic ultrasound (EUS) with pathological complete response (pCR), partial response in the primary tumor, stable disease or progressive disease as defined by EUS criteria.

Outcome measures

Measure	Open Label, Single Arm n=15 Participants Capecitabine, docetaxol
Number of Participants With Pathological Response pathological complete response (pCR)	0 Participants
Number of Participants With Pathological Response partial response	4 Participants
Number of Participants With Pathological Response stable disease	8 Participants
Number of Participants With Pathological Response progressive disease	3 Participants

SECONDARY outcome

Timeframe: up to 8 years

Population: 1 participant was lost to follow-up after progression from neoadjuvant chemotherapy.

Median number of months participants alive at the time of observation. Calculated using Kaplan-Meier method.

Outcome measures

Measure	Open Label, Single Arm n=17 Participants Capecitabine, docetaxol
Overall Survival	17.1 months Interval 7.4 to 84.7

SECONDARY outcome

Timeframe: up to 5 years

Outcome measures

Measure	Open Label, Single Arm n=18 Participants Capecitabine, docetaxol
Progression-free Survival as Measured by Number of Participants Without Disease Progression.	3 Participants

SECONDARY outcome

Timeframe: up to 5 years

Number of participants who experience Grade 3/4 neutropenia, Grade 3 nausea or Grade 3 diarrhea.

Outcome measures

Measure	Open Label, Single Arm n=18 Participants Capecitabine, docetaxol
Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE. Grade 3/4 neutropenia	10 Participants
Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE. Grade 3 nausea	1 Participants
Feasibility and Safety of Pre-operative Chemotherapy in Locally Advanced Gastric Cancer as Assessed by Number of Participants Who Experienced Adverse Events Grade 3 or Higher as Defined by CTCAE. Grade 3 diarrhea	2 Participants

SECONDARY outcome

Timeframe: up to 5 years

Population: Data was not collected to assess this outcome measure.

Initially, we also planned to study the thymidylate synthetase expression, methylation of RUNX-3 gene[24] and comprehensive genomic hybridization[25] before and after chemotherapy to look for biomarkers of response and prognostic indication. But due to the lack of pCR and the small number of patients enrolled, we stopped the correlative studies.

Outcome measures

Outcome data not reported

Adverse Events

Open Label, Single Arm

Serious events: 1 serious events

Other events: 18 other events

Deaths: 11 deaths

Serious adverse events

Measure	Open Label, Single Arm n=18 participants at risk Capecitabine, docetaxol
Cardiac disorders Myocardial infarction	5.6% 1/18 • Number of events 1

Other adverse events

Measure	Open Label, Single Arm n=18 participants at risk Capecitabine, docetaxol
Blood and lymphatic system disorders Anemia	11.1% 2/18 • Number of events 2
Gastrointestinal disorders Constipation	22.2% 4/18 • Number of events 4
Gastrointestinal disorders constipation	5.6% 1/18 • Number of events 1
Gastrointestinal disorders Diarrhoea	11.1% 2/18 • Number of events 2
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1
Blood and lymphatic system disorders Neutropenia	33.3% 6/18 • Number of events 6
Skin and subcutaneous tissue disorders Alopecia	11.1% 2/18 • Number of events 2
General disorders Fatigue	11.1% 2/18 • Number of events 2
General disorders Myalgia	16.7% 3/18 • Number of events 3
General disorders Insomnia	11.1% 2/18 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	5.6% 1/18 • Number of events 1

Additional Information

Prof Alex Chang

Johns Hopkins Singapore

Phone: +65 68802220

Email: alexchang@imc.jhmi.edu

Results disclosure agreements

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