Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02

Summary

This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.

Conditions

• Esophageal Neoplasms

Interventions

RADIATION

SIB-IMRT

PTV:50.4Gy/28f, PGTV:59.92Gy/28f

DRUG

Paclitaxel

45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

DRUG

Platinum-Based Drug

Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks

DRUG

Paclitaxel

150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy

DRUG

Platinum-Based Drug

Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Anyang Tumor Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Affiliated Hospital of Hebei University

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Zefen Xiao, MD · The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-01

Primary Completion

2020-08-30

Completion

2021-08-30

Countries

• China

Study Locations