一项针对非常罕见癌症类型的跨国、多肿瘤篮子研究：欧洲癌症研究与治疗组织的II期90101“CREATE”试验。 - Suppr

A multinational, multi-tumour basket study in very rare cancer types: The European Organization for Research and Treatment of Cancer phase II 90101 'CREATE' trial.

作者信息

Péron Julien, Marreaud Sandrine, Staelens Dominiek, Raveloarivahy Tiana, Nzokirantevye Axelle, Flament Jocelyne, Steuve Jonathan, Lia Michela, Collette Laurence, Schöffski Patrick

机构信息

European Organization for Research and Treatment of Cancer, Brussels, Belgium; Oncology Medical Unit, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.

European Organization for Research and Treatment of Cancer, Brussels, Belgium.

出版信息

Eur J Cancer. 2019 Mar;109:192-195. doi: 10.1016/j.ejca.2018.12.013. Epub 2019 Jan 14.

DOI:10.1016/j.ejca.2018.12.013

PMID:30655100

Abstract

摘要

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A multinational, multi-tumour basket study in very rare cancer types: The European Organization for Research and Treatment of Cancer phase II 90101 'CREATE' trial.一项针对非常罕见癌症类型的跨国、多肿瘤篮子研究：欧洲癌症研究与治疗组织的II期90101“CREATE”试验。

Eur J Cancer. 2019 Mar;109:192-195. doi: 10.1016/j.ejca.2018.12.013. Epub 2019 Jan 14.

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609) in Patients with Nonpancreatic Neuroendocrine Tumors.在非胰腺神经内分泌肿瘤患者中进行的双重抗 CTLA-4 和抗 PD-1 阻断的罕见肿瘤 II 期篮子试验（DART SWOG 1609）。

Clin Cancer Res. 2020 May 15;26(10):2290-2296. doi: 10.1158/1078-0432.CCR-19-3356. Epub 2020 Jan 22.

Phase II trials of drug combinations: fairytales or fact?

Eur J Cancer. 2005 Jan;41(2):195-6. doi: 10.1016/j.ejca.2004.09.009.

A multidisciplinary approach is required to increase the quality of phase II/III clinical studies on biotherapies in oncology.需要采用多学科方法来提高肿瘤生物疗法II/III期临床研究的质量。

Ann Oncol. 2007 May;18(5):960-1. doi: 10.1093/annonc/mdm115. Epub 2007 Apr 16.

Paclitaxel added to the cisplatin/etoposide regimen in extensive-stage small cell lung cancer -- the use of complete response rate as the primary endpoint in phase II trials.在广泛期小细胞肺癌中，将紫杉醇添加到顺铂/依托泊苷方案中——在II期试验中以完全缓解率作为主要终点的应用。

Lung Cancer. 2001 May;32(2):155-62. doi: 10.1016/s0169-5002(00)00220-8.

ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901).ENZA-p 试验方案：一项随机二期临床试验，以前列腺特异性膜抗原作为治疗靶点和预后指标，评估恩扎卢胺（ANZUP 1901）治疗转移性去势抵抗性前列腺癌男性患者的疗效。

BJU Int. 2021 Nov;128(5):642-651. doi: 10.1111/bju.15491. Epub 2021 Jul 6.

A phase 2 basket trial of combination therapy with trastuzumab and pertuzumab in patients with solid cancers harboring human epidermal growth factor receptor 2 amplification (JUPITER trial).一项针对携带人表皮生长因子受体2扩增的实体癌患者，使用曲妥珠单抗和帕妥珠单抗联合治疗的2期篮子试验（朱庇特试验）。

Medicine (Baltimore). 2020 Aug 7;99(32):e21457. doi: 10.1097/MD.0000000000021457.

MONARCC: a randomised phase II study of panitumumab monotherapy and panitumumab plus 5-fluorouracil as first-line therapy for RAS and BRAF wildtype metastatic colorectal cancer: a study by the Australasian Gastrointestinal Trials Group (AGITG).MONARCC 研究：帕尼单抗单药治疗及联合氟尿嘧啶一线治疗 RAS 和 BRAF 野生型转移性结直肠癌的随机 II 期研究：澳大利亚胃肠肿瘤研究组（AGITG）的研究。

BMC Cancer. 2021 Aug 18;21(1):932. doi: 10.1186/s12885-021-08644-4.

AGITG MASTERPLAN: a randomised phase II study of modified FOLFIRINOX alone or in combination with stereotactic body radiotherapy for patients with high-risk and locally advanced pancreatic cancer.AGITG 主计划：一项改良 FOLFIRINOX 单独或联合立体定向体部放疗治疗高危和局部进展期胰腺癌患者的随机 II 期研究。

BMC Cancer. 2021 Aug 19;21(1):936. doi: 10.1186/s12885-021-08666-y.

Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial.局部进展期直肠癌行全直肠系膜切除术联合辅助 FOLFOX 化疗的 upfront 根治性手术（TME-FOLFOX）：一项开放标签、多中心、二期随机对照临床试验。

Trials. 2020 Apr 7;21(1):320. doi: 10.1186/s13063-020-04266-6.

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Front Pediatr. 2022 Aug 10;10:910268. doi: 10.3389/fped.2022.910268. eCollection 2022.

Inflammatory myofibroblastic tumour of an unusual presentation in the uterine cervix: a case report.子宫颈罕见表现的炎性肌纤维母细胞瘤：一例报告

World J Surg Oncol. 2021 Nov 20;19(1):331. doi: 10.1186/s12957-021-02438-5.

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EMBO Mol Med. 2020 Nov 6;12(11):e11131. doi: 10.15252/emmm.201911131. Epub 2020 Oct 13.

Reporting of master protocols towards a standardized approach: A systematic review.关于采用标准化方法的主方案报告：一项系统评价。

Contemp Clin Trials Commun. 2019 Jul 4;15:100406. doi: 10.1016/j.conctc.2019.100406. eCollection 2019 Sep.

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A multinational, multi-tumour basket study in very rare cancer types: The European Organization for Research and Treatment of Cancer phase II 90101 'CREATE' trial.

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