Randomized Trial to Evaluate Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Improvement of complete remission
研究概览
简要总结
Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.
详细描述
Pat. with anal carcinoma and treated with standard radiochemotherapy with Mitomycin C and 5-FU will in the experimental arm receive deep regional hyperthermia (6x).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven anal squamous cell carcinoma (SCC) (WHO 2004), including anal canal carcinoma (UICC 2002) and anal margin carcinoma (UICC 2002)
- •All stages except T1 N0 M0 after local excision (UICC 2002)
- •Age ≥ 18 years
- •ECOG Status 0-1
- •Patients that have understand protocol and signed informed consent form
- •Sufficient bone marrow function: WBC ≥ 3,0 x 10^9/l, Platelets ≥ 100 x 10^9/l, Hemoglobin ≥ 10 g/dl
- •Sufficient liver function: Bilirubin < 1,5 mg/dl, SGOT, SGPT, alkaline phosphatase, gGT less than 3 times upper limit of normal
排除标准
- •Stage T1 N0 M0 after local excision (UICC 2002)
- •Uncontrolled, severe cardiac dysfunction (NYHA III/IV)
- •Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- •Myocardial infarction within the past 12 months
- •Congestive heart failure
- •Complete bundle branch block
- •New York Heart Association (NYHA) class III or IV heart disease
- •Chronic inflammatory disease of the intestine
- •Active intractable or uncontrolled infection
- •Chronic diarrhea ( > NCI CTC-Grad 1)
- •Acute thrombosis
- •Collagen vascular disease
- •Cardiac pacemaker
- •HIV-infection; Patients with hepatitis A or B virus infection, with HPV infection or Patients receiving immune suppressive treatment can be included
- •Devices that preclude deep regional hyperthermia (Endoprosthesis, stent in vascular system, acute thrombosis)
- •Any metal implants (with exception of non-clustered marker clips)
- •Conditions that preclude the application of fractionated pelvic radiotherapy
- •Conditions that preclude regular follow-up
- •Pregnant or breast feeding women
- •Prior pelvic radiotherapy
- •Prior chemotherapy
- •Drug addiction
- •On-treatment participation on other trials
- •Prior or concurrent malignancy or leucemia (≤ 5 years prior to enrolment in study) except anal cancer or non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is continuously disease-free
- •The presence of increased radiation sensitivity, for example ataxia teleangiectatica, or similar
- •Psychological, familial, sociological, or geographical condition that would preclude study compliance
研究组 & 干预措施
control arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33
干预措施: Irradiation (Radiation)
control arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33
干预措施: Mitomycin C (Drug)
control arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33
干预措施: 5-Fluorouracil (Drug)
Experimental arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33 Hyperthermia: 6
干预措施: Irradiation (Radiation)
Experimental arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33 Hyperthermia: 6
干预措施: Mitomycin C (Drug)
Experimental arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33 Hyperthermia: 6
干预措施: 5-Fluorouracil (Drug)
Experimental arm
Irradiation 1.8Gy/d; T2N0 55.8Gy; T3N0-T4N0 59.4Gy Chemotherapy: Mitomycin C 10mg/m^2/d on d1 and 29; 5-Fluorouracil 1000mg/m^2/d on d1-5, 29-33 Hyperthermia: 6
干预措施: Hyperthermia (Procedure)
结局指标
主要结局
Improvement of complete remission
时间窗: 12 weeks after start of treatment
次要结局
- Colostomy-free survival(5 years after start of treatment)
- locoregional relapse-free survival(5 years after start of treatment)
- Overall relapse-free survival(5 years after start of treatment)
- Overall survival(5 years after start of treatment)
- Rate of acute and late toxicity(5 years after start of treatment)
- Response rate(5 years after start of treatment)
- Quality of life(5 years after start of treatment)