NCT02644408

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma and performed chemoradiotherapy from the Oct 2014. The patients will be divided into two groups.Experimental group：esophageal cancer patients with oral megestrol chemoradiation. Megestrol（Yining）：160mg/d，po,5 weeks in total，oen week before chemoradiotherapy and one week after chemoradiotherapy. chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.Control group: Esophageal cancer patients with chemoradiation without oral megestrol.chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.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

Type	Name	Description
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2015-12-31
• Last updated: 2021-02-17

Locations

1 site across 1 country: China