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

NCT06775652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2025-01-15

No results posted yet for this study

Summary

This phase III randomized clinical trial compared the long-term survival and safety of neoadjuvant chemoradiotherapy (NCRT) followed by surgery versus surgery with adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Conducted at Sichuan Cancer Hospital, patients were randomly assigned to receive either NCRT (chemotherapy and radiotherapy followed by surgery) or AT (surgery followed by adjuvant therapy based on staging).

The primary outcome was overall survival (OS), with secondary outcomes including disease-free survival (DFS), R0 resection rates, and treatment-related toxicity. A total of 245 patients were randomized, and 224 patients were included in the final analysis.

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

Sponsors & Collaborators

  • Yongtao Han

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-31
Completion
2024-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06775652 on ClinicalTrials.gov