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

NCT03381651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Esophageal Carcinoma
  • Neoadjuvant Chemoradiotherapy
  • Surgery

Interventions

RADIATION

Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation

50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

RADIATION

Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation

41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Weimin Mao, M.D. · Zhejiang Caner Hospital

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
2018-02-22
Primary Completion
2021-02-22
Completion
2023-02-22

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 NCT03381651 on ClinicalTrials.gov