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

Sponsor
The First Affiliated Hospital of Henan University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT02644408
Collaborator
(none)
184
Enrollment
1
Location
2
Arms
74
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:11:1
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The patients and the medical professionals who cared for them were unaware of the assigned study regimen.
Primary Purpose:
Treatment
Official Title:
Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life (QoF) [16 weeks]

      evaluated by EORTC QLQ-C30 questionnaire

    Secondary Outcome Measures

    1. pathological response [16 weeks]

      complete response(CR)

    2. adverse events [16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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≤2.5N,Cr≤1.5N.

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China 471003

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The First Affiliated Hospital of Henan University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT02644408
    Other Study ID Numbers:
    • MAIQF
    First Posted:
    Dec 31, 2015
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology
    Chemoradiotherapy
    Esophageal Squamous Cancer
    Megestrol
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Neoplasms
    Esophageal Squamous Cell Carcinoma
    Megestrol

    Study Results

    No Results Posted as of Feb 17, 2021