CCRT for Esophageal Cancer.

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma

2. Age of 20 -80

3. ECOG performance status: 0-1;

4. No treatments prior to enrollment;

5. At least one measurable lesion on CT, MRI or esophageal barium exam;

6. Normal functions of heart, lung, liver, kidney and bone marrow

7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL

8. Informed consent signed

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;

2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;

3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;

4. Participating in other clinical trials;

5. Pregnancy, breast feeding, or not adopting birth control;

6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities

7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;