Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. KPS≥70

2. Diagnosis of pathologically positive lymph node thoracic esophageal cancer

3. Complete resection

4. Adequate organ function:

Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

Exclusion Criteria:

1. Uncontrolled diabetes

2. Interval between surgery and adjuvant therapy more than 3 months

3. Sign of recurrence on CT scan or ultrasound or PET-CT No palpable supraclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan

4. With Weight loss greater than 10% from baseline

5. With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix

6. Be pregnant