- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644408
Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
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
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471003
- The First Affiliated Hospital of Henan University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
Megestrol(Yining): 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
Other Names:
radiotherapy (radiation): 50Gy in total,2 Gy/d,5d/w.
Other Names:
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.
|
radiotherapy (radiation): 50Gy in total,2 Gy/d,5d/w.
Other Names:
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
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
General Publications
- Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.
- Ezeoke CC, Morley JE. Pathophysiology of anorexia in the cancer cachexia syndrome. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):287-302. doi: 10.1002/jcsm.12059. Epub 2015 Oct 27.
- Ordu C, Pilanci KN, Koksal UI, Okutur K, Saglam S, Tecimer C, Demir G. Can megestrol acetate induce thrombosis in advanced oncology patients receiving chemotherapy? Asian Pac J Cancer Prev. 2014;15(23):10165-9. doi: 10.7314/apjcp.2014.15.23.10165.
- Kanat O. Management of cancer cachexia (reply). Tumori. 2014 Jan-Feb;100(1):e1. doi: 10.1700/1430.15826. No abstract available.
- Greig CA, Johns N, Gray C, MacDonald A, Stephens NA, Skipworth RJ, Fallon M, Wall L, Fox GM, Fearon KC. Phase I/II trial of formoterol fumarate combined with megestrol acetate in cachectic patients with advanced malignancy. Support Care Cancer. 2014 May;22(5):1269-75. doi: 10.1007/s00520-013-2081-3. Epub 2014 Jan 4.
- Hong S, Jeong IG, You D, Lee JL, Hong JH, Ahn H, Kim CS. Safety of megestrol acetate in palliating anorexia-cachexia syndrome in patients with castration-resistant prostate cancer. J Korean Med Sci. 2013 May;28(5):687-92. doi: 10.3346/jkms.2013.28.5.687. Epub 2013 May 2.
- Argiles JM, Anguera A, Stemmler B. A new look at an old drug for the treatment of cancer cachexia: megestrol acetate. Clin Nutr. 2013 Jun;32(3):319-24. doi: 10.1016/j.clnu.2013.01.004. Epub 2013 Jan 22.
- Madeddu C, Dessi M, Panzone F, Serpe R, Antoni G, Cau MC, Montaldo L, Mela Q, Mura M, Astara G, Tanca FM, Maccio A, Mantovani G. Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib +/- megestrol acetate for patients with cancer-related anorexia/cachexia syndrome. Clin Nutr. 2012 Apr;31(2):176-82. doi: 10.1016/j.clnu.2011.10.005. Epub 2011 Nov 1.
- Gullett NP, Mazurak VC, Hebbar G, Ziegler TR. Nutritional interventions for cancer-induced cachexia. Curr Probl Cancer. 2011 Mar-Apr;35(2):58-90. doi: 10.1016/j.currproblcancer.2011.01.001.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Megestrol
Other Study ID Numbers
- MAIQF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Stage III Esophageal Squamous Cell Carcinoma
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnClinical Stage III Esophageal Adenocarcinoma AJCC v8 | Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage III Esophageal Adenocarcinoma AJCC v8 | Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8 | Pathologic Stage IIIA Esophageal Adenocarcinoma... and other conditionsUnited States
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell Carcinoma | Stage I Esophageal Adenocarcinoma | Stage II Esophageal Adenocarcinoma | Stage III Esophageal Adenocarcinoma | Stage I Esophageal Squamous Cell CarcinomaChina
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingStage III Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer... and other conditionsUnited States
-
Fujian Medical University Union HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma Thoracic Stage II | Esophageal Squamous Cell Carcinoma Thoracic Stage III | Esophageal Squamous Cell Carcinoma Thoracic Stage IVChina
-
The First Affiliated Hospital of Henan University...Luoyang Central Hospital; Nanyang Central Hospital; Sanmenxia Central Hospital; Military 150 Hospital and other collaboratorsActive, not recruitingStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
Shanghai Zhongshan HospitalZhejiang Cancer Hospital; Sun Yat-sen University; Cancer Institute and Hospital... and other collaboratorsRecruitingEsophageal Squamous Cell Carcinoma Stage II | Esophageal Squamous Cell Carcinoma Stage IIIChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell CarcinomaChina
-
National Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Metastatic Malignant Neoplasm in the Brain and other conditionsUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH); National...Not yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage II Esophageal Adenocarcinoma AJCC v8 | Clinical Stage II Esophageal Squamous Cell... and other conditionsUnited States
Clinical Trials on Megestrol(Yining)
-
Southwest Oncology GroupNational Cancer Institute (NCI)CompletedBreast Cancer | Hot Flashes
-
Xiaojun ChenZhejiang Cancer Hospital; Fudan University; Shanghai 6th People's Hospital; Shanghai...CompletedEndometrial Adenocarcinoma | Endometrial Atypical HyperplasiaChina
-
Sunnybrook Health Sciences CentreOntario Institute for Cancer ResearchTerminatedEndometrial CancerCanada
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
Par Pharmaceutical, Inc.PRA Health SciencesTerminatedAnorexia | Weight Loss | CachexiaUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAnorexia | Lung Cancer | CachexiaUnited States
-
Bristol-Myers SquibbCompletedHIV Infections | Anorexia | CachexiaUnited States
-
IpsenCompletedEndometrial CancerCzechia, France, United Kingdom, Belgium, Latvia, Hungary, Lithuania, Moldova, Republic of, Poland, Russian Federation, Spain, Ukraine
-
St. Vincent Medical Center - Los AngelesUnknownBreast Cancer | Malignant Mesothelioma | Endometrial CancerUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)CompletedFatigue | Unspecified Adult Solid Tumor, Protocol Specific | CachexiaUnited States