Trial Outcomes & Findings for Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction (NCT NCT01766986)

NCT ID: NCT01766986

Last Updated: 2021-01-06

Results Overview

Overall survival after surgery (months)

• Recruitment status: COMPLETED
• Target enrollment: 130 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2021-01-06

Participant Flow

Participant milestones

Measure	Group 1 Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the final histological report confirmed an AOG type I	Group 2 Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the final histology showed AOG type II	Group 3 Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
Overall Study STARTED	41	51	38
Overall Study COMPLETED	41	51	38
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Staging and Outcome Depending on Surgical Treatment in Adenocarcinomas of the Oesophagogastric Junction

Baseline characteristics by cohort

Measure	Group 1 n=41 Participants Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the final histological report confirmed an AOG type I	Group 2 n=51 Participants Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the final histology showed AOG type II	Group 3 n=38 Participants Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy	Total n=130 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	62 years n=7 Participants	63 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	48 Participants n=7 Participants	33 Participants n=5 Participants	115 Participants n=4 Participants

PRIMARY outcome

Timeframe: 36 months

Overall survival after surgery (months)

Outcome measures

Measure	Group 1 n=41 Participants Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the final histological report confirmed an AOG type I	Group 2 n=51 Participants Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the final histology showed AOG type II	Group 3 n=38 Participants Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
Overall Survival	12 participants	11 participants	13 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=41 participants at risk Patients with an adenocarcinoma of the oesophagogastricjunction (AOG) type I who underwent oesophagectomy and inwhom the final histological report confirmed an AOG type I	Group 2 n=51 participants at risk Patients with an AOG staged as type I before surgerywho underwent oesophagectomy but the final histology showed AOG type II	Group 3 n=38 participants at risk Patients with an AOG staged as typeII both before and after surgery who underwent extendedgastrectomy
Investigations Adverse event	0.00% 0/41	0.00% 0/51	0.00% 0/38

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthias Reeh

University Hospital Hamburg-Eppendorf

Phone: +49015222816521

Email: m.reeh@uke.de

Results disclosure agreements

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