Comparing Paclitaxel/Cisplatin and Cisplatin/5-fluorouracil in Neo-CRT for ESCC

Summary

Participation Requirements

Description

Stage 1: Neoadjuvant chemoradiation (CRT): Stage 2: Evaluation of clinical responses Evaluation will be done at 3±1 weeks after completing the last fraction of radiotherapy. Evaluation will be performed with panendoscopy, endoscopic ultrasonography (EUS), computed tomography (CT), and positron emiss...

Stage 1: Neoadjuvant chemoradiation (CRT): Stage 2: Evaluation of clinical responses Evaluation will be done at 3±1 weeks after completing the last fraction of radiotherapy. Evaluation will be performed with panendoscopy, endoscopic ultrasonography (EUS), computed tomography (CT), and positron emission tomography (PET). Stage 3: Surgery Patients will receive esophagectomy with two field lymph node dissection unless: A. Patients become medically unfit for surgery. B. Tumor becomes metastatic or unresectable. C. Patients refuse surgery. Patients who do not receive surgery will go on a second section of CRT: A. Radiation: 180cGy/fraction, once daily, 5 days a week, up to a total of 6,300cGy. B. Arm A: i. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 3 during CRT. ii. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 3 during CRT. C. Arm B: i. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 during CRT. ii. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 during CRT. Patients, who receive surgery with R2 resection or the pathology showing positive margins or extracapsular invasion of regional lymph nodes, will also receive the second section of CRT described in above-mentioned stage 3-2.

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