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Docetaxel, Oxaliplatin and 5-FU in Metastatic Gastric Adenocarcinoma With Inoperable Malignant Bowel Obstruction

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ClinicalTrials.gov Identifier: NCT04840264
Recruitment Status : Not yet recruiting
First Posted : April 9, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary:
This is a study of docetaxel, oxaliplatin and 5-Fluorouracil for advanced gastric or gastroesophageal junction adenocarcinoma with inoperable malignant bowel obstruction: the triplet regimen will be given as 1st, 2nd or 3rd 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
Metastatic Gastric Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Drug: Docetaxel Drug: Oxaliplatin Drug: 5Fluorouracil 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. In Cohort 1, participants who have received at least two prior therapies for their advanced disease will receive the experimental regimen. In Cohort 2, participants who have received only one previous therapy for their disease will receive the same regimen. In Cohort 3, participants who have not received any previous therapy will receive the triplet combination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Non-Randomized, Multi-Cohort Trial of Docetaxel, Oxaliplatin and 5-Fluorouracil in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma With Inoperable Malignant Bowel Obstruction
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3rd Line Therapy
Docetaxel 25mg/m, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m, ivdrip 180 min, D1, D15; 5Fu 1200mg/m, civ 24 hours, D1, D8, D15 Repeat every 4 weeks.
Drug: Docetaxel
25 mg/m, D1, D8, D15, repeat every 4 weeks.

Drug: Oxaliplatin
85 mg/m, , D1, D15, repeat every 4 weeks.

Drug: 5Fluorouracil
1200 mg/m, D1, D8, D15, repeat every 4 weeks.
Other Name: 5-FU

Experimental: 2nd Line Therapy
Docetaxel 25mg/m, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m, ivdrip 180 min, D1, D15; 5Fu 1200mg/m, civ 24 hours, D1, D8, D15 Repeat every 4 weeks.
Drug: Docetaxel
25 mg/m, D1, D8, D15, repeat every 4 weeks.

Drug: Oxaliplatin
85 mg/m, , D1, D15, repeat every 4 weeks.

Drug: 5Fluorouracil
1200 mg/m, D1, D8, D15, repeat every 4 weeks.
Other Name: 5-FU

Experimental: 1st Line Therapy
Docetaxel 25mg/m, ivdrip 60 min, D1, D8, D15; Oxaliplatin 85mg/m, ivdrip 180 min, D1, D15; 5Fu 1200mg/m, civ 24 hours, D1, D8, D15 Repeat every 4 weeks.
Drug: Docetaxel
25 mg/m, D1, D8, D15, repeat every 4 weeks.

Drug: Oxaliplatin
85 mg/m, , D1, D15, repeat every 4 weeks.

Drug: 5Fluorouracil
1200 mg/m, D1, D8, D15, repeat every 4 weeks.
Other Name: 5-FU




Primary Outcome Measures :
  1. Obstruction Clearance disease control response [ Time Frame: 30 days ]
    Proportion of patients with Obstruction Clearance


Secondary Outcome Measures :
  1. Time to Obstruction Clearance [ Time Frame: 30 days ]
    From recruitment to obstruction clearance

  2. Strangulation [ Time Frame: 30 days ]
    Proportion of patients with strangulated bowel

  3. Overall Survival [ Time Frame: 3 years ]
    From recruitment to death or last follow-up

  4. Quality of Life assessed by EORTC C-30 [ Time Frame: 3 years ]
    The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) C-30 questionaire is a general patient self-evaluation of subjective quality life status. The score of this questionnaire ranges between 0 and 30. The higher score indicates the worse quality of life



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age;
  • Diagnosis of bowel obstruction secondary to gastric or Gastroesophageal Junction adenocarcinoma caused either by tumor itself or adhesions in the setting of active malignancy;
  • Cross-sectional imaging performed within 7 days of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain);
  • Patient must be considered as inoperable MBO by a surgical consultant;
  • Written informed consent form patients;

Exclusion Criteria:

  • Bacteremia/septicemia with a documented positive blood culture;
  • Patients already received the same regimen prior to study enrollment;
  • Patients undergoing bowel surgery or stent placement for the obstruction;
  • Those patients complicated with incarcerated hernia;
  • Pregnant or nursing female participants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840264


Contacts
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Contact: Jian Xiao, PhD 13711114566 Xiaoj26@mail.sysu.edu.cn

Locations
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China, Guangdong
The Sixth Affiliated hosipital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Contact: Jian Xiao, PhD    13711114566    Xiaoj26@mail.sysu.edu.cn   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Chair: Jian Xiao, PhD The Sixth Affiliated hospital, Sun Yat-Sen University
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Responsible Party: Jian Xiao, Asso Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04840264    
Other Study ID Numbers: SAHMO204
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University:
Bowel Obstruction, Docetaxel, Oxaliplatin, 5-Fluorouracil
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Intestinal Obstruction
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Docetaxel
Fluorouracil
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs