A Randomised Phase II Trial of Iron Isomaltide Versus Oral Iron Supplement for Radiotherapy or Chemotherapy Associated Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Hematopoietic response rate
研究概览
简要总结
Primary purpose： To evaluate the difference of hematopoietic response rate at 1 month after concurrent chemoradiotherapy between iron isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.
Secondary purpose:
To evaluate the difference of hematopoietic response rate, tolerance, acute side effects, qualtiy of life at 2 months and 3 months after concurrent chemoradiotherapy between Iron Isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.
详细描述
Iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma will be enrolled and receive iron Isomaltide or oral iron supplement after randomised. The hematopoietic response rate, tolerance, acute side effects, qualtiy of life and long time survival would be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer and sign the informed consent in person.
- •Aged 18-65
- •Pathological diagnosis of non-keratinizing NPC (differentiated or undifferentiated, as WHO II, III type).
- •Clinical stage of III-IVA（8thAJCC/UICC staging system）
- •Complete induction chemotherapy and concurrent chemoradiotherapy.
- •With ECOG score 0-
- •Female subjects: surgical sterilization or postmenopausal patients, or agree to use a medical approved contraceptive measure such as Intrauterine device (IUD), contraceptives or condoms during the study period.
- •HGB <130g/L(male)，HGB<120g/L(female).
- •Serum ferritin≤800ug/L。
- •Liver function: ALT, AST < 2.5 times the upper limit of normal (ULN), total bilirubin < 2.0 × ULN;
- •Renal function: serum creatinine <1.5×ULN.
排除标准
- •Recurrence or distant metastasis nasopharyngeal carcinoma.
- •Keratinizing squamous cell carcinoma (WHO type I).
- •Pregnant or breastfeeding women, who are in their childbearing years and have not used effective contraception.
- •Previous or concurrently with other malignancies, exclude cured skin basal cell carcinoma and cervical carcinoma in situ.
- •Patients with severely diminished functions of the heart, liver, lung, kidney and bone marrow;
- •Serious, unmanaged medical conditions and infections.
- •Those with other therapeutic contraindications.
- •Use of other investigational medications or clinical studies concurrently.
- •Refused or incapacity to sign the informed consent to participate in the study.
- •People having mental or personality disorders, disability, or limited civil capacity.
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
- •HGB>130g/L(male)，HGB >120g/L(female).
- •Received transfusion therapy before.
- •Receipt of oral or IV iron supplements or ESAs up to 4 weeks before inclusion
- •Ferritin > 800 ng/ml
- •Ongoing bleeding.
研究组 & 干预措施
Iron Isomaltide
Patients receive iron Isomaltide after anti-tumor therapy.
干预措施: Iron Isomaltoside 1000 (Drug)
Iron Isomaltide
Patients receive iron Isomaltide after anti-tumor therapy.
干预措施: Intensity-modulated radiotherapy (Radiation)
Oral iron supplement
Patients receive polysaccharide iron complex after anti-tumor therapy.
干预措施: Polysaccharide Iron Complex Pill (Drug)
Oral iron supplement
Patients receive polysaccharide iron complex after anti-tumor therapy.
干预措施: Intensity-modulated radiotherapy (Radiation)
结局指标
主要结局
Hematopoietic response rate
时间窗: 1 month
Hematopoietic response rate at one month after IC+CCRT.
次要结局
- The difference of HGB(1,2,3 months)
- Acute side effects(1 month)
- Quality of life scores(1 month)
- The score of concise fatigue scale(1,2,3 months)
- Hematopoietic response rate(3 month)
- The difference of serum iron(1,2,3 months)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University