ITMCTR2000003345
Recruiting
Phase 2
Prospective Randomized Controlled Clinical Study for Lung Health Beverage in Preventing Radiotherapy-Related Lung Diseases in Locally Advanced Esophageal Cancer
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine0 sitesTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. pathological confirmed of esophageal squamous cell carcinoma;
- •2\. TNM stage T3\-4N0M0, TxN1\-2M0, TxNxM1a (cervical lymph node metastasis);
- •3\. Patients with expected survival \>\=6 months;
- •4\. Patients aged 18 to 80 years;
- •5\. Patients with ECOG 0\-1;
- •6\. Patients with sufficient main organ function
- •(1\) Hemopoietic function: hemoglobin \>\= 100g/L, platelet \>\= 90 x 10^9/L, neutrophil \>\= 1\.5x10^9/L;
- •(2\) Renal function: serum creatinine SCR \< 1\.5 ULN;
- •(3\) Liver function: ALT and AST \< ULN one point five Times, bilirubin \<1\.5 x ULN;
- •7\. The patient must sign the informed consent of receiving concurrent radiotherapy and chemotherapy.
Exclusion Criteria
- •1\. Patients who have previously suffered from or complicated with other malignant tumors (except melanoma skin tumors) and whose diseases are not controlled or cured (depending on the disease type of the primary tumor);
- •2\. Patients who have previously treated with thoracic radiotherapy;
- •3\. Patients with congenital or acquired immune deficiency;
- •4\. HIV positive patients, including those who have received antiretroviral therapy; chronic hepatitis B, virus replication period; active period of hepatitis C;
- •5\. Pregnancy (confirmed by serum or urine beta\- hCG test) or lactation period;
- •6\. The general condition of the patients was poor, KPS \< 70;
- •7\. Patients have conditions that researchers believe may increase the risk of treatment or have serious uncontrollable complications.
Outcomes
Primary Outcomes
Not specified
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