Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Camptothecin; Irinotecan

Criteria

Inclusion Criteria:

• Histologically proven esophageal squamous cell carcinoma;

• 18 ≤ age ≤ 70;

• ECOG 0-2;

• Previously Treated with platinum or paclitaxel based regimen;

• Uni-dimensionally measurable disease (CT or MRI as per RECIST);

• Patients should have a projected life expectancy of at least 3 months;

• Completion of baseline quality of life questionnaire

• Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);

• Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

• liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)

• Written informed consent

Exclusion Criteria:

• Previous chemotherapy with 5-FU or irinotecan after recurrence or metastasis;

• adjuvant chemotherapy with 5-FU-based chemotherapy within 6 months prior to the start of study treatment;

• Active infection requiring antibiotics

• Pregnant, lactating women

• Psychiatric illness, epileptic disorders

• Concurrent systemic illness not appropriate for chemotherapy

• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma