2024-517300-10-01招募中3 期
Preventive HIPEC in combination with perioperative FLOT versus FLOT alone for resectable diffuse type gastric and gastroesophageal junction Type II/III adenocarcinoma – The phase III “PREVENT” trial of the AIO /CAOGI /ACO
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 28
- 主要终点
- PFS/DFS, defined as the time from randomization to disease progression or relapse after surgery or death from any cause. If no event is observed PFS/DFS is censored at the time of last tumor assessment.
研究概览
简要总结
The primary efficacy objective of the study is to compare progression/disease-free survival (PFS/DFS) in patients.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed, medically operable, resectable diffuse or mixed type (according to Lauren’s classification) adenocarcinoma of the gastroesophageal junction (AEG II-III) or the stomach (uT3, uT4a, any N category, M0), or any T N+ M0 patient.
- •Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
- •Patient has received 3 to 6 cycles of neoadjuvant FLOT (de-escalation or dose modification allowed)
- •No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT (including de-escalated or dose reduced schema) therapy
- •No prior partial or complete tumor resection
- •Female and male patient ≥ 18 and ≤ 75 years. Female patient with childbearing potential needs to have a negative pregnancy test within 7 days prior to study start. Males and females of reproductive potential must agree to practice highly effective contraceptive measures* during the study. Male patients must also agree to refrain from father a child during treatment and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure. *highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- •Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs). Exclusion of the infiltration of any adjacent organs or structures by CT or MRI
- •Laparoscopic exclusion of peritoneal carcinomatosis at initial staging, before start of FLOT chemotherapy
- •Hematological, hepatic and renal function parameters adequate to allow surgical procedure and HIPEC at investigator´s discretion.
排除标准
- •Patient without neoadjuvant therapy or those who received a neoadjuvant therapy other than FLOT
- •Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or ascites.
- •On-treatment participation in another interventional clinical study in the period 30 days prior to inclusion and during the study.
- •Patient pregnant or breast feeding, or planning to become pregnant.
- •Patient in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
- •Any other concurrent antineoplastic treatment including irradiation
- •Known intraabdominal adhesion situs
- •Pre-existing peritoneal seeding
- •Known hypersensitivity against 5-FU, leucovorin, oxaliplatin, or docetaxel
- •Other known contraindications against, 5-FU, leucovorin, oxaliplatin, or docetaxel
- •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- •Clinically significant valvular defect
- •Past or current history of other malignancies not curatively treated and without evidence of disease for more than 3 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix.
- •Criteria of primary unresectability, e.g.: Radiologically documented evidence of major blood vessel invasion or invasion of adjacent organs (T4b). Patients with involved retroperitoneal (e.g. para-aortal, paracaval or interaortocaval lymph nodes) or mesenterial lymph nodes (distant metastases!).
- •Other severe internal disease or acute infection
- •Patient has undergone major surgery within 28 days prior to enrollment.
结局指标
主要结局
PFS/DFS, defined as the time from randomization to disease progression or relapse after surgery or death from any cause. If no event is observed PFS/DFS is censored at the time of last tumor assessment.
PFS/DFS, defined as the time from randomization to disease progression or relapse after surgery or death from any cause. If no event is observed PFS/DFS is censored at the time of last tumor assessment.
次要结局
- OS, defined as the time from randomization to death from any cause If no event is observed OS is censored at the day of last subject contact.
- Rate of patients with peritoneal relapse at 2 and 3 years in both arms.
- PFS/DFS rates at 2, 3 & 5 years defined as the percentage of patients without disease progression or relapse after surgery or death from any cause after 2, 3 and 5 years referring to the total number of patients randomized into the respective treatment arm.
- OS rates at 3 & 5 years defined as the percentage patients known to be alive after 3 and 5 years referring to the total number of patients randomized into the respective treatment arm.
- Rate of surgical serious adverse events, according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 5.0) grade ≥ 3 adverse events and grade ≥ 3 laboratory toxicities.
- OS and PFS/DFS (medians and rates) according to subgroup (diffuse vs. mixed and gastric vs. GEJ type II/III).
- Quality of life (QoL) – EORTC QLQ C30 and EORTC QLQ STO22 questionnaire: The QoL analyses will include QoL mean values, QoL response and time to symptom deterioration (TTSD) defined as the time interval between randomization and the first decrease by ≥ 10-points. All randomly assigned patients with a baseline and at least one post-baseline assessment will be included in TTSD analyses. Patients without observed deterioration will be censored at the time of their last QoL assessment.
- Post-operative morbidity/mortality at day 30 after surgery acc. to Clavien–Dindo classification.
- Post-operative Pain according to VAS (visual analog scale): The patient´s assessment of their current level of pain on a 100-mm horizontal VAS. The left-hand extreme of the line should be described as “no pain” and the right-hand as “unbearable pain”.
研究者
Prof. Dr. Thorsten Götze
Scientific
Krankenhaus Nordwest GmbH
研究点 (28)
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