Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study

Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study - Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer – phase I study(MMTG study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000246

Enrollment

Registered

2005-09-22

Start date

2005-09-01

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

unresectable, locally recurrent or remnant gastric cancer

Interventions

Treatments consisted of chemotherapy of biweekly paclitaxel plus cisplatin and concurrent radiation for 5 weeks for unresectable, locally recurrent or remnant gastric cancer.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients underwent gastrectomy for histologically proven adenocarcinoma of the stomach 2) Unresectable, locally recurrent or remnant gastric cancer of left upper abdomen with invasion to the small intestine or local pain 3) Eastern Clinical Oncology Group (ECOG) performance status of 0-1 4) Prior chemotherapy within 1 regimen except adjuvant chemotherapy or neo-adjuvant chemotherapy 5) No prior chemotherapy of paclitaxel plus cisplatin, or no administration of cisplatin >= 240mg/m2 6) Prior chemotherapy completed 3 weeks before entry 7) No prior radiation therapy to the local area 8) Life expectancy more than 2 months 9) Adequate bone marrow function; white blood cell [WBC] count between 4000/ml and 10000/ml neutrophil count >=2000/ml platelet count >=100000/ml hemoglobin >= 8.0 g/dl GOT and GPT < 100U/l serum bilirubin level < 2.0 mg/dl serum creatinine level < 1.5 mg/dl normal electrocardiogram (ECG) 10) No other active malignancy 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Local tumor is not identified by computerized tomography (CT), endoscope or gastrointestinal examination 2) Other severe medical conditions 3) Patients need treatments for bowel obstruction or bleeding 4) Obvious infection or acute inflammatory condition 5) Allergy to drugs containing Cremophor EL (including cyclosporin) 6) Brain metastases with clinical symptom 7) Women who is pregnant, lactating or have the possibility of pregnancy 8) Patients who is judged inappropriate by lead principal investigator

Design outcomes

Primary

Measure	Time frame
Recommended dose	—

Secondary

Measure	Time frame
1) Dose-limiting toxicities 2) Maximum-tolerated dose 3) The improved rate of bowel stenosis 4) The improved rate of pain relief 5) Overall survival	—

Countries

Japan

Contacts

Public ContactMasayuki Kimura

St.Marianna University School of Medicine Hospital The Department of Gastrointestinal Surgery

m2kimura@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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

Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen &#8211; phase I study