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

Primary Purpose

Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Megestrol（Yining）

radiotherapy

chemotherapy

About this trial

This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Henan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Megestrol and chemoradiotherapy

chemoradiotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Quality of Life (QoF)

evaluated by EORTC QLQ-C30 questionnaire

Secondary Outcome Measures

pathological response

complete response(CR)

adverse events

Full Information

NCT ID

NCT02644408

First Posted

November 27, 2015

Last Updated

February 16, 2021

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT02644408

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2014 (Actual)

Primary Completion Date

December 1, 2019 (Actual)

Study Completion Date

December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Keywords

Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

1:1

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The patients and the medical professionals who cared for them were unaware of the assigned study regimen.

Allocation

Randomized

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Megestrol and chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

chemoradiotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Megestrol（Yining）

Other Intervention Name(s)

Yining

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Other Intervention Name(s)

radiation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

chemotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quality of Life (QoF)

Description

evaluated by EORTC QLQ-C30 questionnaire

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

pathological response

Description

complete response(CR)

Time Frame

16 weeks

Title

adverse events

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shegan Gao, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ruinuo Jia, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tanyou Shan, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xinshuai Wang, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jiachun Sun, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Guoqiang Kong, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaozhi Yuan, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaoshan Feng, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Zhuo, MD, PhD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jing Ren, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ruina Yang, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Weijiao Yin, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wei Wang, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yali Zhang, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Wang, MD

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Henan University of Science and Technology

City

Luoyang

State/Province

Henan

ZIP/Postal Code

471003

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20888705

Citation

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.

Results Reference

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PubMed Identifier

26675762

Citation

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.

Results Reference

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PubMed Identifier

25556442

Citation

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Results Reference

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PubMed Identifier

24675504

Citation

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

Results Reference

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PubMed Identifier

24389826

Citation

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.

Results Reference

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PubMed Identifier

23678259

Citation

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Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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

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