NCT03623737

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

A Randomized Phase II/III Study of Paclitaxel/Cisplatin Versus Cisplatin/5-fluorouracil in Neoadjuvant Chemoradiation Followed by Surgery for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial has two stages: phase II and phase III. Eligible patients will be randomized 1:1 to the two arms: paclitaxel plus cisplatin and cisplatin plus 5-fluorouracil. The phase II stage will enroll 128 patients, 64 patients for each arm. The endpoint of the phase II stage is complete pathological response (pCR). If the endpoint, i.e., the significant improvement of pCR rate, is met, the clinical trial will proceed to the phase III stage, in which 120 more patients will be enrolled. The estimated enrollment time is four years with 3 more years of follow-up after completing enrollment. The primary endpoint of the clinical trial is overall survival, and the secondary endpoints include clinical response, disease free survival, operation rate, complete resection rate, tumor regression rate, hospital stay days after surgery, safety and toxicity, and quality of life.

Detailed description

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

Conditions

• Esophageal Squamous Cell Carcinoma
• Chemoradiation

Interventions

Type	Name	Description
DRUG	neoadjuvant chemoradiation	Neoadjuvant chemoradiation: 1. Radiation: 180cGy/fraction, once daily, 5 days a week, to a total of 4,500cGy. 2. Chemotherapy: Arm A or Arm B Surgery: esophagectomy and 3-fields lymph node dissection

Timeline

• Start date: 2017-03-01
• Primary completion: 2023-03-01
• Completion: 2023-12-01
• First posted: 2018-08-09
• Last updated: 2022-06-07

Locations

1 site across 1 country: Taiwan