Clinical trial NCT02644408: Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Official title: Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage III Esophageal Squamous Cell Carcinoma
Stage II Esophageal Squamous Cell Carcinoma
Keywords: Chemoradiotherapy
Esophageal Squamous Cancer
Megestrol
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 184
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life (QoF)
timeFrame: 16 weeks
Secondary outcomes:
measure: pathological response
timeFrame: 16 weeks
measure: adverse events
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Shegan Gao, MD, PhD
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruinuo Jia, MD, PhD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Tanyou Shan, MD
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xinshuai Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jiachun Sun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Guoqiang Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaozhi Yuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Xiaoshan Feng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Zhuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Jing Ren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Ruina Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Weijiao Yin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Wei Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Yali Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Dan Wang, MD
role: PRINCIPAL_INVESTIGATOR
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