Assess the prolongation of life with 2 different chemotherapy regimens in advanced gastric cancers

Phase 2

• Conditions: Health Condition 1: C169- Malignant neoplasm of stomach, unspecified

• Registration Number: CTRI/2020/03/023944
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Histologically confirmed adenocarcinoma of the gastroesophageal junction or the stomach any T, any N category, M1 , or any T, any N category, M0, but unresectable disease ,

2) ECOG performance status 0 to 2

3) Patient who can give informed consent for the study.

4) Patient does not have any contraindications to receive chemotherapy

5) Adequate hematological, hepatic and renal function parameters

6) Normal cardiac ejection fraction, as assessed by echocardiography

7) Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

8) Written patient consent form

Exclusion Criteria

1) Patient having Her 2 positivity and planned for her2 directed therapy in combination with chemotherapy

2) Known hypersensitivity against, 5-FU, capecitabine, leucovorin, oxaliplatin or docetaxel

3) Known contraindications against 5-FU, leucovorin, capecitabine, oxaliplatin, or docetaxel

4)Previous history of treatment with docetaxel, 5 FU, oxaliplatin, or capecitabine

5)Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV

6) Clinically significant valvular defect

7)Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix

8) Known brain metastases

9)Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy

10) Other severe internal disease or acute infection

11)Baseline neuropathy > NCI Grade I

12)Chronic inflammatory bowel disease

13) On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study

14) Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified