A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)

A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III) - A phase III trial to evaluate extensive intraoperative peritoneal lavage for patients with SS/SE/SI gastric cancer (CCOG 1102, Extensive Lavage PHASE III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005907

Enrollment

300

Registered

2011-07-08

Start date

2011-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cT3(SS) or cT4 (SE/SI) gastric cancer

Interventions

A: standard lavage B: extensive lavage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1st inclusion criteria (before surgery) 1) Histologically proven primary gastric adenocarcinoma 2) cT3(SS)-T4b(SI) 3) cH0 and M0 4) Scheduled open surgery 5) Possible for R0 or R1 surgery by distal or total gastrectomy with D2 lymphadenectomy 5) Length of esophageal invasion less or equal to 3cm and no need of thoracotomy for resection 7) Not stump cancer of stomach 8) Age 20 to 80 years old 9) PS(ECOG) of 0 or 1 10) Adequate organ functions for gastrectomy 11) Written informed consent from patient 2nd inclusion criteria (during surgery) 1) cT3(SS) - cT4b(SI) 2) cH0 M0 3) No peritoneal dissemination or a few peritoneal dissemination around stomach 4) Possible for R0 or R1 surgery due to only CY1 5) No need of thoracotomy for resection

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Uncontrollable hypertension or uncontrollable diabetes mellitus 3) Continuous systemic steroid therapy 4) Judged by physician inadequate for inclusion in this trial

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Overall survival, peritoneal recurrence-free survival, surgical complications	—

Countries

Japan

Contacts

Public ContactKazunari Misawa

Aichi Cancer Center Hospital Department of Gastroenterological Surgery

misawakzn@aichi-cc.jp0527626111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026