Trial Outcomes & Findings for Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (NCT NCT01683864)

Results Overview

Three patients were enrolled in the study. No study results because no patient has received study drug.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

3 participants

Primary outcome timeframe

5 Years

Results posted on

2018-01-30

Participant Flow

Study was early terminated due to recruitment problem. All active patient have study

Participant milestones

Participant milestones
Measure	Positive Cytology With HIPEC gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin	Positive Cytology Without HIPEC gastric cancer cytology positive without HIPEC	Negative Cytology Without HIPEC gastric cancer with negative cytology
Overall Study STARTED	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Cytology With HIPEC gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative positive cytology with HIPEC: HIPEC with mytomycin and cisplatin	Positive Cytology no HIPEC gastric cancer cytology positive without HIPEC	Negative Cytology Without HIPEC gastric cancer with negative cytology	Total Total of all reporting groups
Age, Categorical <=18 years	0 n=5 Participants	0 n=7 Participants	0 n=5 Participants	0 n=4 Participants
Age, Categorical Between 18 and 65 years	—	—	—	0 n=4 Participants
Age, Categorical >=65 years	—	—	—	0 n=4 Participants
Sex: Female, Male Female	0 n=5 Participants	0 n=7 Participants	0 n=5 Participants	—

PRIMARY outcome

Timeframe: 5 Years

Population: No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.

Three patients were enrolled in the study. No study results because no patient has received study drug.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 years

No study results because no patient has received study drug.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 days

No study results because no patient has received study drug.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after application

Outcome measures

Outcome data not reported

Adverse Events

Positive Cytology With HIPEC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Positive Cytology no HIPEC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Negative Cytology Without HIPEC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Alfred Königsrainer

University Clinic of Tübingen

Phone: 0049 7071 2983290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place