Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy

Summary

Megestrol is a semisynthetic progesterone derivatives, have promote anabolic effects. Can improve appetite, weight gain, and improve bone marrow suppression, increase the tolerance put, chemotherapy, improve the quality of life, is widely used in tumor radiation and chemotherapy of terminally ill patients. But because of its vascular embolization, vaginal bleeding, arrhythmia and other serious complications, there is no unified standard.

The purpose of this study was to evaluate megestrol in esophageal squamous carcinoma radical chemoradiation curative effect and side effects, for rational use in the process of radiation and chemotherapy megestrol provide guidelines. A total of 210 patients will be accrued from China.The primary end point is quality of life (will be evaluated by EORTC QLQ-C30); the secondary end point is the pathological response after treatment and adverse events.

Conditions

• Stage III Esophageal Squamous Cell Carcinoma
• Stage II Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Megestrol（Yining）

Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.

RADIATION

radiotherapy

radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.

OTHER

chemotherapy

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total or capecitabine(Aibin) plus Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. or cisplatin: 75mg/m2 d1，29 5-Fu：750mg/m2CIV24h d1-4，d29-32. The 3 regimens were Randomly distributed to patients.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology

  lead OTHER

Principal Investigators

• Shegan Gao, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Ruinuo Jia, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Tanyou Shan, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Xinshuai Wang, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Jiachun Sun, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Guoqiang Kong, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaozhi Yuan, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Xiaoshan Feng, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Zhuo, MD, PhD · The First Affiliated Hospital of Henan University of Science and Technology

• Jing Ren, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Ruina Yang, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Weijiao Yin, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Wei Wang, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Yali Zhang, MD · The First Affiliated Hospital of Henan University of Science and Technology

• Dan Wang, MD · The First Affiliated Hospital of Henan University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-01

Primary Completion

2019-12-01

Completion

2020-12-01

Countries

• China

Study Locations