A phase I trial of intraperitoneal docetaxel and cisplatin with S-1 for treatment of gastric cancer with peritoneal dissemination

A phase I trial of intraperitoneal docetaxel and cisplatin with S-1 for treatment of gastric cancer with peritoneal dissemination - A phase I trial of intraperitoneal docetaxel and cisplatin with S-1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021376

Enrollment

Registered

2016-03-07

Start date

2014-10-01

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

gastric cancer with periotoneal metastasis

Interventions

CDDP is administered intraperitoneally with an initial dose of 25 mg/m2 (level 1), stepped up to 45 mg/m2 at day1,15 depending on observed toxicity. DOC is administered intraperitoneally at a dose of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. presence of gastric adenocarcinoam confirmed by histopathology 2. presence of peritoneal metastasis confirmed by staging laparoscopy or MDCT 3. presence of mesurable or evaluable lesion 4. no prior treatment of chemotherapy or radiation therapy against any other malignancies 5. aged 20 to75 year old 6. performance status of 0 or 2 on Eastern Cooperative Oncology Group (ECOG) scale 7.with adequate oran function 8.sufficient oral intake 9.expected survival period over 3 months. 10.written informed consent 11.with a good condition of important organs recent 14 days a)WBC>=3,000/mm3 b)neutrophil>=1,500/mm3 c)platelet>=100,000/mm3 d)hemoglobin>=9.0g/dl e)total bilirubin<=2.0mg/dl f)AST(GOT)<=150IU/L g)ALT(GPT)<=150IU/L h)serum creatinine<=1.2mg/dl i)creatinin clearance>=50ml/min

Exclusion criteria

Exclusion criteria: 1.with history of allergy against S-1,docetaxel,or cisplatin 2.with following severe diseases a)uncontrolled DM b)ischemic heart disease/arrythmia requiring treatment c)liver cirrhosis and/or liver failure d)heart failure, cardic infarction during recent 6 months e) known bleeding disorders 3.active infection diseases with fever 4.pleural or cardiac effusion requiring treatment 5.symptomatic brain metastasis 6.with active double cancer 7.interstitial pneumonitis, pulmonary fibrosis 8.neurological disorder 9.no current pregnancy or lactation 10.with massive ascites 11.patients whom doctor decide not ro register to this study

Design outcomes

Primary

Measure	Time frame
Recommended dose (RD)	—

Countries

Japan

Contacts

Public ContactJun Kinoshita

Kanazawa University Department of Gastroenterologic Surgery

junkino0416@gmail.com+81-76-265-2362

Outcome results

None listed

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