2024-515344-23-00招募中2 期
PHASE II study evaluating the benefit of Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 13
- 主要终点
- 1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification
研究概览
简要总结
1: Evaluating the efficacy of the Gembrax/Folfirinox chemotherapy sequence 2: To assess the tolerability of MRI-guided adaptive stereotactic radiotherapy in non-progressive patients after SEQ 1.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment Period
- 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
- •Patient between 18 and 75 years of age on the date of signing the consent form
- •Histologically or cytologically proven pancreatic adenocarcinoma.
- •Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 1
- •Non-resectability criteria, according to NCCN 1.2015 recommendations (Appendix 14) validated during centralized review.
- •Non-metastatic patient confirmed by TAP scan and liver MRI
- •Feasibility of MRI-guided radiotherapy confirmed by centralized review
- •CA 19.9 < 500 IU/mL (without icteric cholestasis). If CA 19.9 between 500 IU/mL and 1000 IU/mL, patient may be included if PET scan and peritoneal MRI (peritoneal MRI optional) show no distant metastasis. If CA 19.9 >1000 IU/ML, the patient cannot be included.
排除标准
- •Any previous treatment for pancreatic cancer (chemotherapy, radiotherapy, surgery, targeted therapy or experimental therapy, etc.).
- •Other concomitant cancer or history of cancer, with the exception of treated cervical cancer in situ, basal or squamous cell skin carcinoma, superficial bladder tumor (Ta, Tis, and T1) or curatively treated tumor of good prognosis without chemotherapy and without evidence of disease within 3 years prior to inclusion.
- •History of radiotherapy leading to a foreseeable overlap with the radiotherapy treatment under study (history of abdominal irradiation)
- •Peripheral neuropathy ≥ grade 2
- •ECG with QTc interval greater than 450 ms for men and greater than 470 ms for women
- •Intolerance or allergy to one of the study drugs (gemcitabine, Nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or to an excipient of one of the drugs (e.g. fructose) described in the Contraindications or Warnings and Special Precautions sections of the SPCs or Prescribing Information.
- •Pregnant or breast-feeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion.
- •Brivudine-based treatment within 4 weeks before or after 5-fluorouracil treatment (potentially fatal interaction).
- •Patient having received a live attenuated vaccine within 10 days prior to inclusion and up to 6 months following cessation of chemotherapy.
结局指标
主要结局
1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification
1: Non-progression rate at 4 months (SEQ1 success rate) according to RECIST 1.1 criteria 2: Rate of RT-related acute digestive non-toxicity within 90d of grade ≥3 assessed by NCI CTC AE v5.0 classification
次要结局
- Tolerance of chemotherapy sequence assessed by NCI CTC AE v5.0 classification
- Tolerance (acute and delayed toxicities) of radiotherapy sequence assessed by NCI CTC AE v5.0 classification
- Collection of dosimetric results obtained in terms of dose/volume on predictive dosimetry (PTV coverage by prescription dose on totalized dosimetry, dose received at GTV....)
- Collection and summation of dosimetric results obtained in terms of dose/volume for adaptive radiotherapy sessions, and comparison with predictive dosimetry.
- Correlation of dose to organs at risk (duodenum, small intestine, stomach, colon) with the occurrence of digestive toxicities (predictive and adaptive dosimetry)
- Correlation of PTV coverage and GTV dose with progression-free survival and overall survival (predictive and adaptive dosimetry)
- Progression-free survival defined as time from radiotherapy start date to date of 1st documented progression or date of death from any cause. - Overall survival defined as time from radiotherapy start date to date of death from any cause.
- Overall survival defined as time from radiotherapy start date to date of death from any cause.
- Local disease control rate defined as the proportion of patients without local progression, with time to local progression defined as the time from radiotherapy start date to the date of documented local progression. Patients without local progression will be censored at the date of last news
- Progression-free survival defined as time from inclusion to date of 1st documented progression or date of death from any cause.
- Overall survival defined as time from date of inclusion to date of death from any cause.
- Tolerance of overall treatment assessed by NCI CTC AE v5.0 classification.
- Resection rate defined as the percentage of patients operated on up to 6 months post-radiotherapy.
- R0 resection rate
- Histological response rate* according to CAP score30, 31, 32
- Assess the prognostic impact of CA 19.9 evolution on survival
- Evolution of Quality of Life scores assessed by the EORTC QLQ-C30 and PAN 26 questionnaires.
研究者
Dr Fabienne PORTALES
Scientific
Institut Regional Du Cancer De Montpellier
研究点 (13)
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