Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Chemoradiotherapy, Esophageal Squamous Cancer, Megestrol
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.
Interventions
DRUGMegestrol（Yining）
Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
RADIATIONradiotherapy
radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.
OTHERchemotherapy
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.
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patients and the medical professionals who cared for them were unaware of the assigned study regimen.
Intervention model description
1:1
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoF) | 16 weeks | evaluated by EORTC QLQ-C30 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 16 weeks | — |
| pathological response | 16 weeks | complete response(CR) |
Countries
China
Outcome results
None listed