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 30-day Obstruction Clearance Rate 30 days proportion of participants who achieved obstruction clearance within 30 days from start of treatment
Time to Obstruction Clearance 60 days interval from start of treatment to obstruction clearance
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
The Sixth Affiliated hosipital, Sun Yat-Sen University🇨🇳Guangzhou, Guangdong, ChinaJian Xiao, PhDContact13711114566Xiaoj26@mail.sysu.edu.cn