Different Radiation Dose of Neoadjuvant Chemoradiation for Resectable Thoracic Esophageal Squamous Carcinoma

Not Applicable

Completed

• Conditions: Neoadjuvant Chemoradiotherapy; Esophageal Carcinoma; Surgery
• Interventions: Radiation: Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation; Radiation: Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

• Registration Number: NCT03381651
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.

In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown.

The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Study Start: 2018-02-22
• Primary Completion: 2021-02-22
• Status Verified: 2022-03
• Study Completion: 2023-02-22
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

Age:18-70 years

Histologically verified squamous carcinoma of the thoracic esophagus.

Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.

Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.

Joined the study voluntarily and signed informed consent form

No surgical contraindications

No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≤ 2.5 x ULN, creatinine≤1.5 x ULN

Exclusion Criteria

Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).

Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.

Invasion of the tracheobronchial tree or aorta

Tracheoesophageal fistula

Concurrent pregnancy or lactation

Severe diabetes mellitus with poor blood glucose control

History of a second malignancy

Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.

Patients undergoing esophageal reconstruction with jejunum.

Patients have allergy reaction or contraindications to taxanes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation	Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation	Neoadjuvant chemoradiation: RT: 50.4Gy/28F/5.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 6 wks; Surgery: 4-6 weeks after nCRT
Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation	Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation	Neoadjuvant chemoradiation: RT: 41.4Gy/23F/4.6W; CT: paclitaxel 50mg/m2 d1, qw + CBP AUC2 d1, qw, weekly for 5 wks; Surgery: 4-6 weeks after nCRT

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 year	Time from randomization to tumor progression or any deaths

Secondary Outcome Measures

Name	Time	Method
Complete pathological response rate	analysis is completed 4 weeks after surgery	using the Chirieac grading system
Treatment failure pattern	2 year	including local recurrence or distant metastasis or both
Overall survival	5 year	by intention to treat and per protocol analyses in each study arm
R0 resection rate in each arm	analysis is completed 4 weeks after surgery	no cancer cells seen microscopically at the resection margin
Postoperative complications in each study arm	30 and 90 days after surgery	According to the NCI CTC3.0

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China