Neoadjuvant Chemoradiotherapy Plus Surgery vs. Surgery Plus Adjuvant Therapy for ESCC

PHASE3CompletedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

July 31, 2024

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
DRUG

Neoadjuvant Chemoradiotherapy

Patients assigned to the NCRT group received intravenous paclitaxel (135 mg/m²) and carboplatin (AUC=2-5) on day 1, administered every three weeks for two cycles. Concurrently, they received intensity-modulated radiotherapy (IMRT) with a total of 20 sessions (CTV 40 Gy, GTV 44 Gy) five days per week. All radiotherapy plans were reviewed by designated radiation oncologists before treatment to ensure quality control. Patients were assessed 4 to 6 weeks after completing NCRT following RECIST 1.1 criteria.

PROCEDURE

Adjuvant therapy

Patients in the AT group received surgery as soon as possible after randomization, followed by adjuvant therapy, postoperative adjuvant therapy based on pathological staging, as recommended by the NCCN Clinical Practice Guidelines for Esophageal and Esophagogastric Junction Cancers (2017 V4), starting one month post-surgery with either adjuvant chemotherapy or chemoradiotherapy. The adjuvant chemotherapy regimen was the same as the neoadjuvant chemotherapy regimen, and the adjuvant radiotherapy regimen and dose were administered according to guideline recommendations.

PROCEDURE

Surgery

Surgery

Trial Locations (1)

610041

Sichuan Cancer Hospital and Institute, Chengdu

All Listed Sponsors
lead

Yongtao Han

OTHER

NCT06775652 - Neoadjuvant Chemoradiotherapy Plus Surgery vs. Surgery Plus Adjuvant Therapy for ESCC | Biotech Hunter | Biotech Hunter