2024-518131-11-02招募中2 期
Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA7 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年1月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 7
- 主要终点
- Phase IIa: Proportion of patients who negativize ctDNA after treatment.
研究概览
简要总结
Phase IIa: To analyse the potential effect of FOLFOXIRI as an intensive adjuvant treatment for ctDNA clearance as a surrogate biomarker of treatment efficacy. Phase IIb: To study differences on the conversion rate between an intensive adjuvant treatment (FOLFOXIRI) versus conventional adjuvant therapy (CAPOX).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •CIRCULATE-SPAIN-01 trial written informed consent.
- •Age ≥ 18 years and ≤ 75 years.
- •Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer.
- •Postoperative, ctDNA positive.
- •ECOG performance status 0-
- •Normal organ functions, as follows: Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100.000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 x ULN AST (SGOT) and ALT (SGPT) ≤2.5 x ULN
排除标准
- •Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice).
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
- •Pre-existing neuropathy > grade
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment.
- •Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
- •Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
- •Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
- •Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required.
- •Has a known history of active TB (Bacillus Tuberculosis).
- •History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- •Had an incomplete diagnostic colonoscopy and/or polyps’ removal for patients in whom the remaining colon was not removed or explored. Note: Patients with intraoperative complete colonoscopy or early perioperative complete colonoscopy and/or patients with incomplete colonoscopy, but who do have a CT colonoscopy or intraoperative colonoscopy, may be eligible to be recruited in the study.
- •Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).
- •Current treatment with another investigational drug or participation in another investigational study
- •Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- •Inadequate contraception (male or female patients) if of childbearing or procreational potential.
- •Current clinically unresolved cardiovascular disease.
结局指标
主要结局
Phase IIa: Proportion of patients who negativize ctDNA after treatment.
Phase IIa: Proportion of patients who negativize ctDNA after treatment.
Phase IIb: Proportion of patients who negativize ctDNA after treatment in intensive group versus standard of care.
Phase IIb: Proportion of patients who negativize ctDNA after treatment in intensive group versus standard of care.
次要结局
- Phase IIb:Disease-free survival comparison between both treatment groups 24 months after treatment.
- Phase IIb: Disease-free survival comparison between both treatment groups 12 months after treatment.
- Phase IIb: Proportion of patients treated with triplet combination chemotherapy of FOLFOXIRI presenting adverse events in comparison to conventional adjuvant treatment (CAPOX).
- Phase IIb: QLQ-C30 Quality of Life of Cancer Patients and QLQ – CR29, comparison scores between groups at baseline, 3 months and end of treatment.
研究者
UICEC
Scientific
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
研究点 (7)
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