Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
Conditions
Keywords
Malignant Bowel Obstruction, Docetaxel, Oxaliplatin, Fluorouracil
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.
Interventions
DRUGDocetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
DRUGOxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
DRUGFluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Guangdong Provincial People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 60-day Obstruction Clearance Rate | 60 days | proportion of participants who achieved obstruction clearance within 60 days from start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
CONTACTJian Xiao, MD
STUDY_CHAIRJian Xiao, MD
Guangdong Provincial People's Hospital
Outcome results
None listed