Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

Peritoneal Carcinomatosis Clinical Trial

Official title:

A Multi-center, Non-randomized, Three-cohort, Phase II Trial of a Modified Triplet Combination of Docetaxel, Oxaliplatin and Fluorouracil for Gastric Cancer With Peritoneal Carcinomatosis and Inoperable Malignant Bowel Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840264
• Other study ID #: ZhenJing
• Status: Recruiting
• Phase: Phase 2
• Start date: January 7, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: March 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jian Xiao, MD
• Phone: 86-20-38250745
• Email: xiao_jian[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Intestinal Obstruction
• Metastatic Gastric Adenocarcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Drug:
• Docetaxel
25 mg/square metre, D1, D8, D15, repeat every 4 weeks.
• Oxaliplatin
85 mg/msquare metre, D1, D15, repeat every 4 weeks.
• Fluorouracil
1200 mg/square metre, D1, D8, D15, repeat every 4 weeks.

Locations

Country	Name	City	State
China	The Sixth Affiliated hosipital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Anthony T, Baron T, Mercadante S, Green S, Chi D, Cunningham J, Herbst A, Smart E, Krouse RS. Report of the clinical protocol committee: development of randomized trials for malignant bowel obstruction. J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S49-59. doi: 10.1016/j.jpainsymman.2007.04.011. Epub 2007 Jun 4. — View Citation

Madariaga A, Lau J, Ghoshal A, Dzierzanowski T, Larkin P, Sobocki J, Dickman A, Furness K, Fazelzad R, Crawford GB, Lheureux S. MASCC multidisciplinary evidence-based recommendations for the management of malignant bowel obstruction in advanced cancer. Support Care Cancer. 2022 Jun;30(6):4711-4728. doi: 10.1007/s00520-022-06889-8. Epub 2022 Mar 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	60-day Obstruction Clearance Rate	proportion of participants who achieved obstruction clearance within 60 days from start of treatment	60 days
Secondary	30-day Obstruction Clearance Rate	proportion of participants who achieved obstruction clearance within 30 days from start of treatment	30 days
Secondary	Time to Obstruction Clearance	interval from start of treatment to obstruction clearance	60 days
Secondary	Obstruction Clearance Duration	interval from obstruction clearance to the next malignant bowel obstruction	2 years
Secondary	Safety in terms of Adverse Events	according to Common Terminology Criteria for Adverse Events version 5.0	2 years
Secondary	Overall Survival	interval from start of treatment to death or last follow-up	2 years
Secondary	Quality of Life assessed by EORTC QLQ-OG25	in terms of European Organization for Research and Treatment of Cancer Quality of Life questionnair OG25	3 months