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

NCT02644408 | Completed Phase 3 DMC

• 1 other identifier: MAIQF
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Keywords

Chemoradiotherapy; Esophageal Squamous Cancer; Megestrol

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QoF)

  evaluated by EORTC QLQ-C30 questionnaire

  16 weeks

Secondary Outcomes (2)

• pathological response

  16 weeks

• adverse events

  16 weeks

Study Arms (2)

Megestrol and chemoradiotherapy

EXPERIMENTAL

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）; Radiation: radiotherapy; Other: chemotherapy

chemoradiotherapy

ACTIVE COMPARATOR

chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w.

Radiation: radiotherapy; Other: chemotherapy

Interventions

Megestrol（Yining） DRUG

Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.

Also known as: Yining

Megestrol and chemoradiotherapy

radiotherapy RADIATION

radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.

Also known as: radiation

Megestrol and chemoradiotherapy; chemoradiotherapy

chemotherapy OTHER

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.

Megestrol and chemoradiotherapy; chemoradiotherapy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Related Publications (9)

• 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.

  PMID: 20888705 BACKGROUND

• 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.

  PMID: 26675762 BACKGROUND

• 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.

  PMID: 25556442 BACKGROUND

• Kanat O. Management of cancer cachexia (reply). Tumori. 2014 Jan-Feb;100(1):e1. doi: 10.1700/1430.15826. No abstract available.

  PMID: 24675504 BACKGROUND

• 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.

  PMID: 24389826 BACKGROUND

• 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.

  PMID: 23678259 BACKGROUND

• 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.

  PMID: 23395103 BACKGROUND

• 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.

  PMID: 22047681 BACKGROUND

• 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.

  PMID: 21420558 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy; Radiation; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Shegan Gao, MD, PhD

  The First Affiliated Hospital of Henan University of Science and Technology

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and the medical professionals who cared for them were unaware of the assigned study regimen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 31, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: February 17, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)