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

Phase 3

Completed

• Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: radiotherapy; Drug: Megestrol（Yining）; Other: chemotherapy

• Registration Number: NCT02644408
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Brief 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.

Study Timeline

• Study Start: 2014-10-01
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Status Verified: 2019-10
• Primary Completion: 2019-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Age 45-75years old
• Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
• The patients have not received the surgery or chemo-radiotherapy.
• Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
• ALT、AST≤2.5*N,Cr≤1.5*N.
• performance status score 0-2

Exclusion Criteria

• Pregnant, lactating women
• Oxaliplatin or fluorouracil Allergy or metabolic disorders
• Radiotherapy contraindications
• History of organ transplantation
• Brain metastasis
• The peripheral nervous system disorders
• Severe infection
• Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
• Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
• Other malignant tumor in recent 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Megestrol and chemoradiotherapy	chemotherapy	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.
chemoradiotherapy	radiotherapy	chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.
Megestrol and chemoradiotherapy	Megestrol（Yining）	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.
Megestrol and chemoradiotherapy	radiotherapy	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.
chemoradiotherapy	chemotherapy	chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.

Primary Outcome Measures

Name	Time	Method
Quality of Life (QoF)	16 weeks	evaluated by EORTC QLQ-C30 questionnaire

Secondary Outcome Measures

Name	Time	Method
pathological response	16 weeks	complete response(CR)
adverse events	16 weeks

Trial Locations

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China