Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
- Conditions
- Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPeritoneal Carcinomatosis
- Interventions
- Registration Number
- NCT04840264
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.
- Detailed Description
The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 79
- 18-75 years of age;
- ECOG PS ≤3;
- pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
- peritoneal carcinomatosis established by imaging data or pathological evidence;
- MBO below the Treitz ligament based on clinical grounds or radiological findings;
- considered as inoperable MBO by two independent surgical consultants;
- Hb≥60g/L, WBC ≥4×10E9/L, ANC≥2×10E9/L，PLT≥100×10E9/L;
- Cr≤ Upper Normal Limit(UNL);
- Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;
- Written informed consent form paticipants.
- treated by a combination regimen containing all the study drugs;
- allergy to any of the study drugs;
- HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
- strangulated intestinal obstruction;
- active gastrointestinal bleeding;
- uncontrolled active infection;
- unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
- severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);
- mental disorders that affect clinical treatment or central nervous system diseases;
- concomitant cerebral parenchymal or meningeal metastasis;
- HIV infection or untreated active hepatitis;
- bowel surgery or stenting required due to obstruction;
- pregnant or lactating women;
- other conditions that are not suitable for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B (Second-Line Therapy) Fluorouracil Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. C (Third- or Later-Line Therapy) Docetaxel Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. C (Third- or Later-Line Therapy) Oxaliplatin Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. A (First-Line Therapy) Docetaxel Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. A (First-Line Therapy) Oxaliplatin Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. A (First-Line Therapy) Fluorouracil Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. B (Second-Line Therapy) Oxaliplatin Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. B (Second-Line Therapy) Docetaxel Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks. C (Third- or Later-Line Therapy) Fluorouracil Docetaxel 25 mg/square metre, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85 mg/square metre, ivdrip 180 min, D1, D15; 5Fu 1200 mg/square metre, civ 24 hours, D1, D8, D15; Repeat every 4 weeks.
- Primary Outcome Measures
Name Time Method 60-day Obstruction Clearance Rate 60 days proportion of participants who achieved obstruction clearance within 60 days from start of treatment
- Secondary Outcome Measures
Name Time Method Time to Obstruction Clearance 60 days interval from start of treatment to obstruction clearance
30-day Obstruction Clearance Rate 30 days proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Obstruction Clearance Duration 2 years interval from obstruction clearance to the next malignant bowel obstruction
Safety in terms of Adverse Events 2 years according to Common Terminology Criteria for Adverse Events version 5.0
Overall Survival 2 years interval from start of treatment to death or last follow-up
Quality of Life assessed by EORTC QLQ-OG25 3 months in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25
Trial Locations
- Locations (1)
The Sixth Affiliated hosipital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China