Adjuvant Therapies or Surgery Alone for High Risk pN0 Esophageal Cancer

Summary

Histological Node Negative thoracic esophageal squamous cell carcinoma（pN0 ESCC） after radical resection still carries the risk of recurrence after complete surgical resection, especially in some high-risk patients. There are still lack of knowledge on postoperative treatment indication and methods for pN0 ESCC.Our previous study has shown that risk of recurrence is associated with the location and cell differentiation of primary tumor, as well as the presence of lymphovascular invasion. This project is designed to study the efficacy of adjuvant therapies for at patients with pN0 ESCC and above mentioned risk factors of recurrence after radical surgery. We aim to compare the differences among adjuvant chemotherapy, adjuvant radiotherapy, and surgery alone for pN0 ESCC by prospective randomized controlled trial. There has been no similar studies in esophageal cancer previously reported with similar design. The results of this study is expected to have a high clinical relevance.

Conditions

• Esophageal Neoplasms

Interventions

DRUG

Adjuvant chemotherapy (Paclitaxel and Cisplatin)

Adjuvant chemotherapy group: three cycles: (Paclitaxel: 175mg/m2 ivgtt, 3h, d1 4week × 3 and cisplatin: 75mg/m2 ivgtt, d1 4 week × 3)

RADIATION

Adjuvant radiotherapy

Target: the upper mediastinum and bilateral supraclavicular region (Upper bound: thyrocricoid, lower bound: carina of 3cm) Dose: 50Gy Technology: strong tone Segmentation: conventional segmentation 2Gy/d

OTHER

Control group (Surgery alone)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Fudan University

  collaborator OTHER

• Qingdao University

  collaborator OTHER

• Fujian Medical University

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Shanghai Chest Hospital

  lead OTHER

Principal Investigators

• Wentao Fang, MD · Shanghai Chest 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

2016-01-31

Primary Completion

2019-01-31

Completion

2021-01-31

Countries

• China

Study Locations