ow dose cancer drugs for advanced stomach cancer
- Conditions
- Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2022/11/047033
- Lead Sponsor
- JIPMER PONDICHERRY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Confirmed histological diagnosis of gastric carcinoma.
2Age 18 years to 70 years at time of enrollment
3Recurrent and refractory gastric carcinoma
4ECOG performance status 0 to 2
5Documented disease progression as evidenced by clinical, radiological or both
6 Normal echocardiogram
7Negative serum pregnancy test in women of child bearing age
1Active bleeding
2History of severe hypersensitivity reaction to paclitaxel.
3Patients having > grade 2 neuropathy
4Patient planned for immunotherapy and anti-her-2 therapies.
5Gastric outlet obstruction(GOO) without appropriate feeding procedure.
6 Biological parameters
1.Absolute granulocytes <= 1500/mm3
2.Platelets <= 75,000/mm3
3.Hemoglobin <= 8 g/L
4.Serum albumin level <= 28 g/L
5.Bilirubin > 1.5 and AST/ALT >= 3 ULN or >= 5 ULN in case of liver metastasis
6.Sr. Creatinine > 2.0 or creatinine clearance of < 50ml/min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MEDIAN PROGRESSION FREE SURVIVALTimepoint: AT THE END OF THE STUDY
- Secondary Outcome Measures
Name Time Method CHANGES IN BIOMARKERSTimepoint: EVERY 3 MONTHLY AND ON PROGRESSION;Frequency of Drug toxicity graded as per CTCAE v5.0 grading.Timepoint: BEFORE EACH CHEMOTHERAPY CYCLE;OVERALL SURVIVALTimepoint: AT THE END OF THE STUDY;QUALITY OF LIFETimepoint: AT THE END OF THE STUDY;RESPONSE RATESTimepoint: AT THE END OF THE STUDY