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Clinical Trials/CTRI/2019/07/020289
CTRI/2019/07/020289
Not yet recruiting
Phase 2

A phase II single arm prospective study to assess the efficacy of Resveratrol-Copper (R-Cu) in ameliorating chemotherapy related toxicity in patients receiving palliative chemotherapy for advanced stage IV inoperable gastric cancers. - RC

Tata Memorial Hospital0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C169- Malignant neoplasm of stomach, unspecified

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
Sponsor
Tata Memorial Hospital
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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, with the following specifications
  • •Radiological evidence of metastatic disease or and unresectable local disease as assessed by surgical oncologist
  • •\-ECOG performance status 0 to 2
  • •\-Patient who can give informed consent for the study
  • •\-Patient does not have any contraindications to receive chemotherapy
  • •\-Adequate Hematological, hepatic and renal function parameters
  • •\-Renal function Creatinine less than or equal to 1\.5 ULN, Creatinine clearance more than or equal to40 mL per min.
  • •\-Normal cardiac ejection fraction as assessed by echocardiography
  • •\-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.
  • •\-patient given informed consent form

Exclusion Criteria

  • •Patients with Her2 positive metastatic adenocarcinoma planned for her2 directed therapy in addition to chemotherapy as first line regimen
  • •\-Known hypersensitivity against cisplatin, 5\-FU, capecitabine, leucovorin, oxaliplatin or docetaxel
  • •Known contraindications against 5\-FU, leucovorin, capecitabine, oxaliplatin, or docetaxel
  • •Previous history of treatment with docetaxel, 5 FU, oxaliplatin, or capecitabine
  • •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III\-IV,
  • •\-Clinically significant valvular defect
  • •\-Past or current history of other malignancies except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
  • •\-Known brain metastases
  • •\-Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
  • •\-Other severe internal disease or acute infection

Outcomes

Primary Outcomes

Not specified

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