2025-523593-16-00招募中3 期
First adjuvant trial in locally resected aggressive pancreatic neuroendocrine tumors: a randomized phase III investigating the efficacy of systemic chemotherapy (ADJUPANET)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 20
研究概览
简要总结
To compare the efficacy of chemotherapy (6 cycles of Capecitabine-Temozolomide) followed by active surveillance to active surveillance only on disease-free survival (DFS) following randomization, for patients with R0-resected stage I-III PanNET at intermediate to high risk of recurrence
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
- •Pathologically proven well differentiated neuro-endocrine tumour of the pancreas by local teams
- •Early postoperative context (≤ 4 months)
- •R0 resection
- •Absence of distant metastasis or local tumor remnant as defined by a negative post-operative thorax CT and -abdomen CT or MRI and negative (best of DOTA-peptide 68Ga or, FDG) PET imaging if performed preoperatively
- •No prior systemic therapy
- •Intermediate to high risk of recurrence as defined by the following situations: -Ki67 ≥ 10% (i.e.: Grade 3 or high Ki67 Grade 2) -Ki67 5-9% AND (tumor size > 3 cm OR Node positive) -Ki67 3-5% AND tumor size > 3 cm AND Node positive -Ki67 < 3% AND tumor size > 3 cm AND Node positive AND (Vascular Emboli OR perineural invasion)
- •Inclusion in this trial must be validated during a multidisciplinary consultation meeting of the regional RENATEN-ENDOCAN board
- •Age ≥ 18 years at the time of consent, no superior limit
- •Adequate bone marrow reserve (hemoglobine > 8, absolute neutrophils count ≥ 1500/mm³ and platelets ≥ 80 000/mm³)
- •Effective contraception: -For women of childbearing potential (WOCBP), must have a negative urine or serum β-HCG pregnancy test 7 days prior to enrolment; If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; and who agree to use a highly effective contraceptive method during and for at least 6 months post-treatment. Sexually active female patients must agree to use an effective contraception -Sexually active men with a woman of childbearing potential must agree to use a highly effective contraceptive method during and for at least 3 months post-treatment. They should refrain from donating sperm during this period. Men should inquire about sperm cryopreservation before initiating treatment.
- •Written, dated and signed informed consent by the patient prior to any specific protocol procedure
- •Ability to comply with the protocol procedures
- •Patient affiliated to a social security system or beneficiary of the same
- •Availability of the primary tumor specimen, allowing accurate WHO classification and determination of MGMT status
- •Stage I-III based ENETS-UICC 8th classification
排除标准
- •Poorly differentiated tumours (NEC)
- •Serum albumin < 3.0 g/dL unless prothrombin time is within the normal range
- •Current treatment with another investigational drug
- •Unrecovered toxicity from surgery
- •Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the Investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- •Dihydropyrimidine dehydrogenase (DPD) deficiency or not done
- •Recent or concomitant treatment with brivudine
- •Hypersensitivity to Capecitabine or Temozolomide or to any of the excipients
- •Mixed NeuroEndocrine Non NeuroEndocrine tumors (MiNEN)
- •Neoadjuvant treatment or treatment with chemotherapy regimen used for another malignancy
- •Pregnant women or breastfeeding women
- •ECOG performance status > 1
- •Age < 18 years
- •PanNET arising in a genetic syndrome with other NETs already diagnosed (NF1, VHL or MEN)
- •History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least five years
- •Severe renal insufficiency (measured GFR according to MDRD < 30 ml/mn or nephrotic syndrome) or hepatic insufficiency (ALT / AST > 2.5 x ULN or ALT/AST > 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin > 2.5 x ULN)
研究者
DRC-PROMOTION- Affaires réglementaires
Scientific
Institut Gustave Roussy
研究点 (20)
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