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

Henan University of Science and Technology

Status and phase: Completed; Phase 3

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Treatments: Other: chemotherapy; Radiation: radiotherapy; Drug: Megestrol（Yining）

Study type: Interventional

Funder types: Other

Identifiers

NCT02644408

MAIQF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups

Megestrol and chemoradiotherapy

Experimental group

Description:

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.

Treatment:

Drug: Megestrol（Yining）

Radiation: radiotherapy

Other: chemotherapy

chemoradiotherapy

Active Comparator group

Description:

chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.

Treatment:

Radiation: radiotherapy

Other: chemotherapy