Docetaxel, Oxaliplatin and 5Fu in Gastric Cancer With Peritoneal Metastasis and Inoperable Malignant Bowel Obstruction
Study Details
Study Description
Brief Summary
This is a study of docetaxel, oxaliplatin and 5-Fluorouracil for advanced gastric or gastroesophageal junction adenocarcinoma with peritoneal involvement and inoperable malignant bowel obstruction: the triplet regimen will be given as 1st, 2nd or later line treatment to participants. The primary study hypothesis is that the regimen will provide a clinically meaningful Bowel Obstruction Remission.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is an open-label non-randomization trail. The study will have 3 cohorts. Cohorts 1 to 3 will run simultaneously with the same regimen. Cohort 1 will include 39 participants who have not received any previous therapy. In Cohort 2, 25 participants who have received only one previous therapy for their disease will be included. In Cohort 3, 25 participants who have received two or more prior therapies for their advanced disease will receive the experimental regimen.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1st Line Therapy Docetaxel 25mg/m2, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m2, ivdrip 180 min, D1, D15; 5Fu 1200mg/m2, civ 24 hours, D1, D8, D15 Repeat every 4 weeks. |
Drug: Docetaxel
25 mg/m2, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/m2, D1, D15, repeat every 4 weeks.
Drug: 5Fluorouracil
1200 mg/m2, D1, D8, D15, repeat every 4 weeks.
Other Names:
|
| Experimental: 2nd Line Therapy Docetaxel 25mg/m2, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m2, ivdrip 180 min, D1, D15; 5Fu 1200mg/m2, civ 24 hours, D1, D8, D15 Repeat every 4 weeks. |
Drug: Docetaxel
25 mg/m2, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/m2, D1, D15, repeat every 4 weeks.
Drug: 5Fluorouracil
1200 mg/m2, D1, D8, D15, repeat every 4 weeks.
Other Names:
|
| Experimental: 3rd or later Line Therapy Docetaxel 25mg/m2, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m2, ivdrip 180 min, D1, D15; 5Fu 1200mg/m2, civ 24 hours, D1, D8, D15 Repeat every 4 weeks. |
Drug: Docetaxel
25 mg/m2, D1, D8, D15, repeat every 4 weeks.
Drug: Oxaliplatin
85 mg/m2, D1, D15, repeat every 4 weeks.
Drug: 5Fluorouracil
1200 mg/m2, D1, D8, D15, repeat every 4 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Obstruction Clearance disease control response [60 days]
Proportion of patients with Obstruction Clearance
Secondary Outcome Measures
- Obstruction Clearance [30 days]
Proportion of patients with Obstruction Clearance
- Time to Obstruction Clearance [60 days]
From recruitment to obstruction clearance
- Obstruction Clearance Duration [3 years]
From obstruction clearance to the time of next obstruction
- Overall Survival [3 years]
From recruitment to death or last follow-up
- Quality of Life assessed by EORTC QLQ-OG 25 [3 years]
The Europe Organization for Research and Treatment of Cancer,Quality of Life Questionnaire-OG 25 can assess quality of life (HRQL) in patients with tumours of the oesophagus, oesophago-gastric junction and stomach.
- Safty [3 years]
Adverse effects recorded according to CTCAE V5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-75 years of age;
-
ECOG PS 0-1, or ECOG PS 2-3 due to the tumor situation or obstruction;
-
Pathologically diagnosed gastric or gastroesophageal junction adenocarcinoma
-
Cohort 1 recruits patients with who have not received any previous therapy. Cohort 2 recruits patients who have received only one previous therapy for the metastatic disease. Cohort 3 recruits patients who have received two or more prior therapies for their metastatic disease.
-
Diagnosis of bowel obstruction below the Treitz ligament by clinical symptoms (nausea, vomiting, and constipation ± abdominal pain) and radiology.
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Diagnosis of peritoneal metastasis by radiology or pathology.
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Patient must be 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;
Exclusion Criteria:
-
Patients who have previously been treated with the three experimental drugs together;
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Severe uncontrolled active infection;
-
HIV infection or untreated active hepatitis;
-
HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
-
Patients with heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
-
Patients with severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
-
Patients with mental disorders that affect clinical treatment or have a previous history of central nervous system diseases;
-
Concomitant parenchymal or meningeal metastases;
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Patients with active gastrointestinal bleeding;
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Allergy to any of the study drugs;
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Strangulated intestinal obstruction;
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According to the judgment of the researchers, the patient needs to undergo bowel surgery or stenting due to obstruction;
-
Pregnant or lactating women, or patients of childbearing age who refuse to use effective contraception during the study period;
-
The researcher believes that the patient has any other conditions that are not suitable for participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Sixth Affiliated hosipital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
- Study Chair: Jian Xiao, PhD, The Sixth Affiliated hospital, Sun Yat-Sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAHMO204