Stage III Esophageal Squamous Cell CarcinomaPhase 3NCT02644408
Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
A Phase 3 study testing Megestrol（Yining）, radiotherapy and chemotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Stage II Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma
- What is being tested?
- Megestrol（Yining）, radiotherapy and chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2014to 1 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant, lactating women
- Oxaliplatin or fluorouracil Allergy or metabolic disorders
- Radiotherapy contraindications
- History of organ transplantation
- Brain metastasis
- The peripheral nervous system disorders
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
About this study
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.
Read the 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.
- Being tested
- Megestrol（Yining）, radiotherapy, chemotherapy
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol（Yining）Drug
Also called Yining
Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
radiotherapyRadiation
Also called radiation
radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.
chemotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Megestrol（Yining）; Radiation: radiotherapy; Other: chemotherapy |
| chemoradiotherapy | Active comparator | chemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w. Receives: Radiation: radiotherapy; Other: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoF)
evaluated by EORTC QLQ-C30 questionnaire
Measured: 16 weeks
Secondary outcomes (2)
pathological response
complete response(CR)
Measured: 16 weeks
adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start1 Oct 2014
- Primary completion1 Dec 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stage III Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, MD, PhD, Study chair, The First Affiliated Hospital of Henan University of Science and TechnologyRuinuo Jia, MD, PhD, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyTanyou Shan, MD, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyXinshuai Wang, MD, PhD, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyJiachun Sun, MD, PhD, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyGuoqiang Kong, MD, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXiaozhi Yuan, MD, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXiaoshan Feng, MD, PhD, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644408
- Sponsor's protocol ID
- MAIQF
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2015
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 20888705Ezeoke 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.
PubMed 26675762Ordu 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.
PubMed 25556442Kanat O. Management of cancer cachexia (reply). Tumori. 2014 Jan-Feb;100(1):e1. doi: 10.1700/1430.15826. No abstract available.
PubMed 24675504Greig 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.
PubMed 24389826Hong 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.
PubMed 23678259Argiles 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.
PubMed 23395103Madeddu 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.
PubMed 22047681Gullett 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.
PubMed 21420558
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megestrol Acetate for the Improvement of Quality of Life in Esophageal Cancer With Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02644408
- Acronym / sponsor ID
- MAIQF
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1
| Arm | Type | Receives |
|---|---|---|
| Megestrol and chemoradiotherapy | Experimental | Drug: Megestrol（Yining）, Radiation: radiotherapy, Other: chemotherapyMegestrol（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 | Active comparator | Radiation: radiotherapy, Other: chemotherapychemoradiotherapy：chemotherapy and radiotherapy： 50Gy in total，2 Gy/d，5d/w. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnant, lactating women
- Oxaliplatin or fluorouracil Allergy or metabolic disorders
- Radiotherapy contraindications
- History of organ transplantation
- Brain metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol（Yining）Also: YiningMegestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy. | Drug | Megestrol and chemoradiotherapy |
| radiotherapyAlso: radiationradiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w. | Radiation | Megestrol and chemoradiotherapy, chemoradiotherapy |
| chemotherapycapecitabine(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. | Other | Megestrol and chemoradiotherapy, chemoradiotherapy |
Primary outcome
Quality of Life (QoF)
Time frame: 16 weeks
evaluated by EORTC QLQ-C30 questionnaire
2 secondary outcomes
pathological response
Time frame: 16 weeks
adverse events
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 20888705Park 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.
- Background: PubMed 26675762Ezeoke 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.
- Background: PubMed 25556442Ordu 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.
- Background: PubMed 24675504Kanat O. Management of cancer cachexia (reply). Tumori. 2014 Jan-Feb;100(1):e1. doi: 10.1700/1430.15826. No abstract available.
- Background: PubMed 24389826Greig 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.
- Background: PubMed 23678259Hong 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.
- Background: PubMed 23395103Argiles 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.
- Background: PubMed 22047681Madeddu 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.
- Background: PubMed 21420558Gullett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shegan Gao, MD, PhD study chair
The First Affiliated Hospital of Henan University of Science and Technology
Ruinuo Jia, MD, PhD study director
The First Affiliated Hospital of Henan University of Science and Technology
Tanyou Shan, MD study director
The First Affiliated Hospital of Henan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol（Yining）, radiotherapy and chemotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Stage II Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoF) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02644408, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.