NCT07591493尚未招募3 期
First Adjuvant Trial in Locally Resected Aggressive Pancreatic Neuroendocrine Tumors: a Randomized Phase III Investigating the Efficacy of Systemic Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
ADJUPANET is an open label, double arm, multicenter, phase 3 trial that aims to investigate the efficacy of systemic chemotherapy in locally resected aggressive pancreatic neuroendocrine tumors. The two arms of patients are the following : i. control arm : active surveillance only, standard of care. ii. experimental arm : adjuvant chemotherapy with 6 cycles of CAPECITABINE-TEMOZOLOMIDE (per os) and active surveillance. Patients enrolled in the experimental arm will receive Capecitabine CAPECITABINE per os 750 mg/m² (twice a day: D1 to D14) D1=D28 and TEMOZOLOMIDE per os 200 mg/m² (once a day: D10 to D14) D1=D28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
- •Availability of the primary tumor specimen, allowing accurate WHO classification and determination of MGMT status
- •Stage I-III based ENETS-UICC 8th classification
- •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)
- •Age ≥ 18 years at the time of consent, no superior limit
- •Adequate bone marrow reserve (hemoglobine > 8 g/dL, absolute neutrophils count ≥ 1500/mm³ and platelets ≥ 80 000/mm³)
- •Effective contraception
- •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
排除标准
- •Poorly differentiated tumours (NEC)
- •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)
- •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
研究组 & 干预措施
Control group
Active Comparator
Active surveillance only
干预措施: Active surveillance (Other)
Experimental group
Experimental
Adjuvant chemotherapy with Capecitabine-Temozolomide followed by active surveillance
干预措施: Adjuvant chemotherapy with Capecitabine-Temozolomide (Drug)
Experimental group
Experimental
Adjuvant chemotherapy with Capecitabine-Temozolomide followed by active surveillance
干预措施: Active surveillance (Other)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: time between randomization and the diagnosis of first recurrence or death, up to 5 years
次要结局
- Specific survival(time from randomization to death due to disease progression, toxicity of the treatment or uncontrollable secretory syndrome, up to 5 years)
- Overall survival(time from randomization to death from any cause, up to 5 years)
- Toxicity assessment(at baseline, every month during the first year and then every year until the end of the study, up to 5 years)
- Time and pattern of recurrence(time from randomization to the detection of recurrence, up to 5 years)
- Quality of life assessment(evolution of the scores collected at baseline, every three months during one year, and then every year until the end of the study, up to 5 years)
研究者
研究点 (1)
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