IRCT2016092529963N1
Completed
Phase 3
Evaluation of the efficacy of Spinal-Z with conventional chemotherapy on the survival of gastric and esophageal cancer patients: A randomized clinical trial
Vice chancellor for research ,Digestive Diseases Research Institute, Tehran University of Medical Sc0 sites83 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Condition 1: Oesophagus cancer. Condition 2: Gastric cancer.
- Sponsor
- Vice chancellor for research ,Digestive Diseases Research Institute, Tehran University of Medical Sc
- Enrollment
- 83
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed esophageal squamous cell carcinoma or Adenocarcinoma of the distal esophagus or gastric cancer; The Largest diameter of the lesion \= 10 mm based on Spiral\-CT Scan; The absence of brain metastases; Karnofsky Performance status scale \=70%; Age\>\=18
- •Exclusion criteria:
- •Congestive heart failure (EF \<\= 40%); Medical history of myocardial infarction during the past 6 months; Concurrent use of Vasodilators; Uncontrolled arrhythmias; Complications in central nervous system (Spinal cord and brain); Medical history of CVA, stroke within the last 6 months; Respiratory failure (PO2\<\= 50 mmHg) for any reason; Level of liver enzymes (AST, ALT) \> 5 folds the normal limits; Bilirubin serum \= 5 mg per deciliter; serum Creatinine level \> 2 milligrams per deciliter); WBC \< 2500 per cubic millimeter of blood; Platelet count \< 100,000 per cubic millimeter of blood ; Pregnant and nursing mothers; Any type of active infection ; IV drug users ; Major psychological disorders
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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