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

February 16, 2021 updated by: The First Affiliated Hospital of Henan University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Megestrol and chemoradiotherapy

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.
Drug: Megestrol（Yining）
Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
Other Names:
  • Yining
Radiation: radiotherapy
radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.
Other Names:
  • radiation
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.
Active Comparator: chemoradiotherapy
chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.
Radiation: radiotherapy
radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.
Other Names:
  • radiation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoF)
Time Frame: 16 weeks
evaluated by EORTC QLQ-C30 questionnaire
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological response
Time Frame: 16 weeks
complete response(CR)
16 weeks
adverse events
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Investigators

  • Study Chair: Shegan Gao, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Study Director: Ruinuo Jia, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Study Director: Tanyou Shan, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Xinshuai Wang, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Jiachun Sun, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Guoqiang Kong, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Xiaozhi Yuan, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Xiaoshan Feng, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Dan Zhuo, MD, PhD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Jing Ren, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Ruina Yang, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Weijiao Yin, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Wei Wang, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Yali Zhang, MD, The First Affiliated Hospital of Henan University of Science and Technology
  • Principal Investigator: Dan Wang, MD, The First Affiliated Hospital of Henan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 27, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAIQF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe