EUCTR2013-001296-20-AT进行中（未招募）1 期
Randomized Phase IV Trial to Compare Cetuximab with Concomitant Radiation Therapy with ConcomitantMitomycin-C and 5-FU with Radiation Therapy for Locally Advanced Squamous Cell Carcinomas of The Head and Neck - MITOCET
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •must have a non non-resectable cancer of head and neck
- •must have pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx or cancer of unknown primary site.
- •must have stage III or IV disease with an expected survival of = 12 months with node status of N0-N2
- •must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy
- •must have a Karnofsky performance status (KPS) of = 70
- •must be age between =18 and =80 years of age
- •must have the following laboratory values:
- •Neutrophilcount= 100/uL= 1.5 x 109/L
- •Platelet count = 80,000/uL = 100 x 1012 /L
- •Bilirubin = 1.5 mg/dL= 25µ M/L
- •SGOT = 2 x the upper limit of normal = 2 x the upper limit of normal
- •SGPT= 2 x the upper limit of normal = 2 x the upper limit of normal
- •Serum creatinine or estimated creatinine clearance=1.5mg/Dl = 50 mL/min = 133µ M/L = 50 mL/min
- •Serum calciumWithin normal limitsWithin normal limits
- •must be disease free from a previously treated malignancy for greater more than three years
- •a history of a previous basal basal cell carcinoma of the skin or pre-invasiv carcinoma of the cervix are no exclusion criteria
- •must provide signed and dated written informed consent
- •Female subjects of childbearing potential must:
- •- Understand that the study medication could have an expected teratogenic risk
- •- Agree to use, and be able to comply with, effective contraception without inter-ruption, 4 weeks before starting study drug, throughout study drug therapy (in-cluding dose interruptions) and for 3 months after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception*
- •Levonorgestrel-releasing intrauterine system (IUS)
- •Medroxyprogesterone acetate depot
- •Tubal sterilisation
- •Sexual intercourse with a vasectomised male partner only; vasec-tomy must be confirmed by two negative semen analyses
- •Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- •* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
- •- Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
- •- Agree to have a medically supervised pregnancy test every 4 weeks including 3 months after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- •Male subjects must:
- •- Agree to use condoms throughout study drug therapy, during any dose interruption and for 3 months after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •- Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •Are the trial subjects under 18? no
- •Number of subjec
排除标准
- •have evidence of distant metastatic disease
- •have received prior systemic chemotherapy within the last three years
- •have undergone previous surgery for the tumour under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx
- •have received prior radiation therapy to the head and neck
- •be receiving radiation therapy as part of a postoperative regimen follow-ing primary surgical resection
- •be pregnant or breast feeding
- •have received prior Cetuximab or murine monoclonal antibody therapy
- •have received prior Mitomycin-C and 5-FU
- •have actual hemorrhages
- •have stomatitis, ulcerations in the mouth and the gastrointestinal tract
- •have actual severe diarrhea
- •have severe infectious diseases (e.g. Hepatitis A, B, C, D and/or HIV)
- •have coagulation disorders
- •have active vaccination
- •have medical or psychological condition that would not permit the patient to complete the trial or sign informed consent
- •have an active participation in another clinical trial
研究者
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