Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial

Comparison of multimodality treatment: 2 or 4courses of neoadjuvant chemotherapy of S-1/CDDP or S-1/CDDP/Docetaxel folloewd by surgery and adjuvant S-1 chemoterapy for locally advanced gastric cancer, a randomized phase 2 trial - COMPASS-D trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006378

Enrollment

120

Registered

2011-09-21

Start date

2011-09-12

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

gastric cancer

Interventions

2 courses of S-1/CDDP 4 courses of S-1/CDDP 2 courses of S-1/CDDP/Docetaxel 4 courses of S-1/CDDP/Docetaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i. Histologically proven adenocarcinoma of the stomach ii. Clinical T4, or T3 disease in cases of tumors invading the esophagus or of the schirrhous type including giant type 3 with a maximal diameter of more than 8 cm, confirmed by abdominal CT and laparoscopy. The T and N stages are determined according to the method proposed by Haberrmann. iii. No pleural effusion, no ascites exceeding pelvis, and no metastasis to the peritoneum, liver, or other distant organs, confirmed by abdominal-pelvic CT. iv. No metastasis to the lung, mediastinal lymph nodes, or the other distant organs, confirmed by thoracic CT for tumors invading the esophagus. v. No clinically apparent distant metastasis vi. Age ranging between 20 and 80. vii. ECOG performance status 0-1 viii. Enough oral intake ix. No previous treatment with chemotherapy or radiation therapy for any tumors x. No previous surgery for the present disease except bypass surgery xi. Sufficient organ functions xii. Written informed consent.

Exclusion criteria

Exclusion criteria: i. Remnant stomach cancer ii. Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included). iii. Females with an on-going pregnancy or breast-feeding, or who are contemplating pregnancy. iv. Mental disorders which may affect the ability or willingness to provide informed consent or abide by the study protocol v. Systemic treatment with a corticosteroid vi. Systemic treatment with flucytosine, phenytoin, or warfarin potassium vii. Allergic reaction to iodine viii. Hypersensitivity to docetaxel, cisplatin, or polysorbate 80 ix. Peripheral neuropathy x. Edema xi. Pneumonitis, lung fibrosis, or emphysema in need for oxygen therapy xii. Active inflammation due to bacteria or fungus xiii. Unstable angina or cardiac infarction within 6 months xiv. Positive for HBs antigen or HCV antibody xv. Unstable hypertension xvi. Diabetes mellitus under treatment.

Design outcomes

Primary

Measure	Time frame
Three-year overall survival rate	—

Secondary

Measure	Time frame
overall survival, progression-free survival, pathological response, clinical response, R0 resection rate, R0R1 resection rate, completion rate of neoadjuvant chemotherapy, incidence of adverse events, and these parameters in each subset	—

Countries

Japan

Contacts

Public ContactTakaki Yoshikawa

Kanagawa Cancer Center Department of Gastrointestinal Surgery

yoshikawat@kcch.jp045-391-5761

Outcome results

None listed

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