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NCT Number: NCT04770623

Docetaxel and Irinotecan in Gastric Cancer

To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.

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Key information

Conditions

Stomach Cancer Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Menoufia University, Faculty of medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care.

Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histopathological evidence of adenocarcinoma of the stomach
  • Metastatic disease or locally advanced non-resectable disease
  • Patients who received only one line of treatment
  • Performance status 0,1,2 as per ECOG scoring system

Exclusion criteria

  • Patients who received docetaxel or irinotecan before recruitment to this study
  • Multiple comorbid conditions
  • Liver or kidney impairment
  • Severe cachexia (sarcopenia)

Treatment and study plan

docetaxel

Drug

patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival

Irinotecan

Drug

patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival

Primary outcomes

  1. Overall response rate (ORR)

    Time frame: 6 months from chemotherapy

    described according to RECIST criteria

Secondary outcomes

  1. Quality of life (QoL)

    Time frame: three months and six months from chemotherapy

    A questionnaire with the QLQ-C30 form will be conducted at enrollment, after 3 months and after end of treatment.

    A score between 1 to 4 will be used in the questionnaire where higher score means worse quality of life.

  2. Progression free survival (PFS)

    Time frame: One year from start of enrollment

    The time interval between starting the test protocol and the next disease progression or death whichever earlier

  3. Overall survival (OS)

    Time frame: One year from start of enrollment

    The time interval between diagnosis and death

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Docetaxel and Irinotecan Combination as a Second Line Treatment of Metastatic Gastric Cancer; a Phase II Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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