Chemotherapy Effect, Gastric Cancer, Stomach Cancer
Conditions
Keywords
gastric, stomach, docetaxel, irinotecan, chemotherapy, second line
Brief summary
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.
Detailed description
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.
Interventions
DRUGDocetaxel
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
DRUGIrinotecan
patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
Sponsors
Menoufia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients from multiple oncology centers across Egypt are recruited for this study. Second line treatment of advanced gastric cancer will be tested with irinotecan and docetaxel combination
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 6 months from chemotherapy | described according to RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QoL) | 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. |
| Progression free survival (PFS) | One year from start of enrollment | The time interval between starting the test protocol and the next disease progression or death whichever earlier |
| Overall survival (OS) | One year from start of enrollment | The time interval between diagnosis and death |
Countries
Egypt
Outcome results
None listed