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

Last updated: February 16, 2021
Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Overall Status: Completed

Phase

3

Condition

Carcinoma

Esophageal Disorders

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02644408
MAIQF
  • Ages 45-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 45-75years old
  • Histologically proven squamous cell carcinoma of the esophagus the tumor was inT2-4N0-2M0
  • 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≤2.5N,Cr≤1.5N.
  • performance status score 0-2

Exclusion

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 ofdigestive ulcer, Gastrointestinal bleeding
  • Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,highblood pressure, diabetes.
  • Other malignant tumor in recent 5 years.

Study Design

Total Participants: 184
Study Start date:
October 01, 2014
Estimated Completion Date:
December 01, 2020

Study 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.

Connect with a study center

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

    Luoyang, Henan 471003
    China

    Site Not Available

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