EUCTR2004-002951-16-IE进行中（未招募）不适用
COIN A three-arm randomised controlled trial comparing either COntinous chemotherapy plus cetuximab or INtermittent chemotherapy with standard coninuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer - COI
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,421
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
- •1. Male/Female patients at least 18 years or over.
- •2. Confirmed colorectal adenocarcinoma: Either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and / or metastatic disease, or histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour.
- •3. Inoperable metastatic or locoregional disease.
- •4. Unidimensionally measurable disease.
- •5. Baseline CT scan must be performed within 4 weeks prior to treatment.
- •6. No previous systemic palliative chemotherapy for metastatic disease
- •7. Adjuvant chemotherapy with 5FU +/- FA, capecitabine or irinotecan may have been given, if completed > 1 month prior to trial entry.
- •8. Rectal chemoradiotherapy with 5FU +/- FA or capecitabine may have been given, if completed > 1 month prior to trial entry.
- •9. WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy.
- •10. Baseline laboratory tests (within 1 week prior to randomisation):
- •Neutrophils = 1.5 x109/l and platelet count = 100 x109/l
- •Serum bilirubin = 1.25 x upper limit of normal (ULN), alkaline phosphatase = 5 x ULN, and serum transaminase (either AST or ALT) = 3 x ULN
- •Estimated creatinine clearance (Cockcroft; Appendix IV) =50ml/min or measured GFR (EDTA clearance) =50 ml/min.
- •11. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions.
- •12. Effective contraception for male patients if the risk of conception exists.
- •13. Written informed consent for participation in the trial.
- •14. Consent to allow surplus pathological material to be analysed for EGFR testing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who are unfit for the chemotherapy regimens in this protocol,
- •Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent MI, i.e. in previous 3 months) likely to interfere with protocol treatments.
- •Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication.
- •Partial or complete bowel obstruction.
- •Pre-existing neuropathy (> grade 1).
- •2. Patients requiring ongoing treatment with a contraindicated concomitant medication.
- •3. Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN treatment or assessment of response.
- •4. Patients with known hypersensitivity reactions to any of the components of the study treatments.
- •5. Patients with brain metastases.
- •6. Patients who are receiving combination chemotherapy prior to the resection of operable liver metastases (but patients of uncertain operability are eligible).
- •7. Patients who have received any prior chemotherapy with Oxaliplatin.
研究者
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