2025-520471-29-00招募中3 期
Efficacy of the use of neoadjuvant with/without hyperthermic intraperitoneal chemotherapy in the treatment of locally advanced colon cancer: A phase III multi-arm, randomized and controlled clinical trial (FOXHIPECT4)
Fundacion Para La Investigacion Biomedica De Cordoba23 个研究点 分布在 1 个国家目标入组 1,083 人开始时间: 2025年6月30日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,083
- 试验地点
- 23
- 主要终点
- disease-free survival (DFS; absolute DFS in months)
研究概览
简要总结
To determine whether the use of proactive systemic neoadjuvant treatment (FOLFOX) with or without HIPEC with mitomycin C followed by post-surgical systemic adjuvant treatment increases disease-free survival at 36 months in patients with locally advanced colon cancer compared to standard treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients of both sexes, aged ≥18 years and ≤75 years
- •Adenocarcinoma of the colon, sigmoid colon and rectum-sigmoid junction that is cT4a/b according to the American Joint Committee on Cancer (AJCC) TNM eigth edition. Pre-treatment diagnosis by imaging test (CT scan or MRI). High-risk cT3 with invasion into surrounding fat greater than 5mm may be included
- •Metastatic extension: M0
- •Microsatellite stability (pMMR)
- •Informed consent duly completed
- •Subjects must agree to utilize a highly effective* method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study (*) Highly effective methods of contraception as defined by the Clinical Trial Facilitation Group (CTFG) (“Recommendations related to contraception and pregnancy testing in clinical trials”, version 15/09/2014) o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) o Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) o Intrauterine device (IUD) o Intrauterine hormone-releasing system (IUS) o Bilateral tubal occlusion o Vasectomised partner o Sexual abstinence
排除标准
- •Presence of metastases (M1). If liver or peritoneal metastases are present at the time of surgery, the patient will be excluded from the study and treated according to the new stage
- •Intolerance to treatment. Hypersensitivity to Mitomycin C, Fluoropyrimidine or oxaliplatin. This means individuals with a history of allergic or other adverse reactions to a these specific drugs or their related substances are excluded from participating.
- •Gestational or lactating women. If female and of childbearing potential, must: - Have a negative pregnancy test ≤72hours prior to initiating study treatment - Agree to avoid pregnancy during and for 6 months after study treatment
- •Presence of un-resectability criteria in the pretreatment work-up, un-resectability will be discussed in MDT with expert oncologic surgeons.
- •Presence of microsatellite instability (dMMR)
- •Presence of deficit of DPD.
- •Coexistence of another malignant neoplastic disease (synchronous colon and rectum-sigmoid tumors are accepted as long as the stage is equal or lower than the treated tumor)
- •Extraperitoneal rectal cancer (medium-low) (avoiding alterations due to neoadjuvant radiotherapy).
- •Coexistence of another malignant neoplastic disease (synchronous colon and rectum-sigmoid tumors are accepted as long as the stage is equal or lower than the treated tumor).
- •Severely impaired hepatic, renal or cardiovascular function.
- •Contraindications to study IMPs (annex I) as per investigator criteria
研究组 & 干预措施
FLUOROURACIL
Test
干预措施: FLUOROURACIL (Drug)
FOLINIC ACID
Test
干预措施: FOLINIC ACID (Drug)
CAPECITABINE
Comparator
干预措施: CAPECITABINE (Drug)
OXALIPLATIN
Test
干预措施: OXALIPLATIN (Drug)
MITOMYCIN
Test
干预措施: MITOMYCIN (Drug)
结局指标
主要结局
disease-free survival (DFS; absolute DFS in months)
disease-free survival (DFS; absolute DFS in months)
Probability of DFS at 3 years (DFS 3y%)
Probability of DFS at 3 years (DFS 3y%)
次要结局
- Pattern of recurrence (peritoneal, hematogenous or lymphatic)
- Tumor regression grade (Dworak scale)
- Overall survival: absolute and probability at 3 years
- Peritoneal recurrence-free survival: absolute and probability at 3 years
- Morbidity and toxicity: Clavien Dindo classification and Common Terminology Criteria for Adverse Events (CTCAE) v5.0 will be considered.
- Negative rate of ctDNA after treatment and association of detected levels with tumor recurrence and survival
- Survival analysis in the following subgroups: pT4a/b, pN+, pathologic stage II/III, mutated RAS/RAF, positive/negative ctDNA
- Tumour progression defined as per RECIST v.1.1: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
研究者
Alvaro Arjona
Scientific
Fundacion Para La Investigacion Biomedica De Cordoba
研究点 (23)
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