研究方案（Study Protocol）

文章类型：
研究方案（Study Protocol）

说明：
介绍具有重要前景的临床试验/研究方案及其进展。研究方案是指计划中的或正在进行的研究。临床试验方案，临床研究方案
通过发表临床研究方案，研究设计者可以向全世界展示他们计划进行的或已经开始的研究，这不仅可以带来科研合作的机会，也可能帮作者吸引到学术会议的邀请。
如果只是作者对国际临床试验的介绍，则希望有助于推广某类研究，促进学科发展。
刊登研究方案有利于研究人员和资助机构及时了解相关领域中尚未广为人知的最新研究活动。这也有利于避免其他团队不必要的重复工作，并促进彼此的合作。此外，与仅按照试验注册的要求填写研究方案相比，全文刊登研究方案还能够使试验计划更为详尽透明，也能够使编辑、审稿人和读者更易于发现、理解试验中与方案不同的各种偏差。
各种重要声明的要求同研究文章。期待各位主要研究者在《循证医学》杂志介绍您的研究方案。

稿件来源：

• 编辑邀稿
• 编委推荐/投稿
• 研究团队投稿
  

写作要求：

• SPIRIT规范（Standard Protocol Items for Randomized Trials，随机试验标准方案条款）。该规范是在对大量资源和共识进行系统综述后编制的循证工具。该标准中既借鉴了 CONSORT 声明，也强调了一些重要的伦理学问题。本刊鼓励作者在起草研究方案时遵循SPIRIT的建议，并在投稿时提交核对清单Checklist。
• PRISMA-P（Preferred reporting items for systematic review and meta-analysis protocols，系统综述和荟萃分析研究方案建议写作条款）。
• PRISMA-P 核对清单列出了系统综述和荟萃分析研究方案的17个最基本的部分。强烈建议系统综述的作者和评价者在起草和评价综述方案时使用PRISMA-P，并在投稿时提交核对清单Checklist。
• 有多家机构提供权威的试验方案下载，如英国国家卫生/医学研究委员会提供的Clinical Trials Toolkit（临床试验操作规范）和美国国家卫生研究院提供的试验方案撰写指南等。BMJ Open接受任何设计类型的研究方案，包括观察性研究和系统综述。
  

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Nakamura K, Saji H, Nakajima R, Okada M, Asamura H, Shibata T, Nakamura S, Tada H, Tsuboi M. A phase III randomized trial of lobectomy versus limited resection for small-sized peripheral non-small cell lung cancer (JCOG0802/WJOG4607L). Jpn J Clin Oncol. 2010 Mar;40(3):271-4. doi: 10.1093/jjco/hyp156. Epub 2009 Nov 22. PMID: 19933688.


JCOG 0802临床试验介绍。

Phase III Randomized Trial of Lobectomy Versus Limited Resection for Small-sized Peripheral Non-small Cell Lung Cancer (JCOG0802/WJOG4607L) | Japanese Journal of Clinical Oncology | Oxford Academic

Eichhorn F, Klotz LV, Bischoff H, Thomas M, Lasitschka F, Winter H, Hoffmann H, Eichhorn ME. Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial. BMC Cancer. 2019 May 2;19(1):413. doi: 10.1186/s12885-019-5624-2. PMID: 31046714; PMCID: PMC6498462.


Neoadjuvant anti-programmed Death-1 immunotherapy by Pembrolizumab in resectable nodal positive stage II/IIIa non-small-cell lung cancer (NSCLC): the NEOMUN trial - PMC

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Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer.Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11. PMID: 35950566.


Full article: LIBRETTO-432, a Phase III Study of Adjuvant Selpercatinib or Placebo in Stage IB-IIIA RET Fusion-Positive Non-Small-Cell Lung Cancer

Zhou Q, Chen M, Wu G, Chang JH, Jiang O, Cui JW, Han G, Lin Q, Fang J, Chen GY, Wu YL. GEMSTONE-301: a phase III clinical trial of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who did not have disease progression after prior concurrent/sequential chemoradiotherapy.Transl Lung Cancer Res. 2020 Oct;9(5):2008-2015. doi: 10.21037/tlcr-20-608. PMID: 33209620; PMCID: PMC7653154.



GEMSTONE-301: a phase III clinical trial of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) non-small cell lung cancer (NSCLC) who did not have disease progression after prior concurrent/sequential chemoradiotherapy - PMC

Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28. PMID: 31948903.


全文：
Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study - Clinical Lung Cancer (clinical-lung-cancer.com)

Recurrence monitoring using ctDNA in patients with metastatic colorectal cancer: COSMOS-CRC-03 and AURORA studies - ScienceDirect
Recurrence monitoring using ctDNA in patients with metastatic colorectal cancer: COSMOS-CRC-03 and AURORA studies - ESMO Gastrointestinal Oncology
E. Oki, R. Nakanishi, K. Ando, I. Takemasa, J. Watanabe, N. Matsuhashi, T. Kato, Y. Kagawa, M. Kotaka, K. Hirata, M. Sugiyama, T. Kusumoto, Y. Miyamoto, K. Toyosaki, J. Kishimoto, Y. Kimura, T. Yoshizumi, Y. Nakamura,
Recurrence monitoring using ctDNA in patients with metastatic colorectal cancer: COSMOS-CRC-03 and AURORA studies,
ESMO Gastrointestinal Oncology, Volume 3, 2024,
https://doi.org/10.1016/j.esmogo.2023.100034.
(https://www.sciencedirect.com/sc ... i/S2949819823000493)
Abstract: International treatment guidelines recommend tumor resection for patients with oligometastatic colorectal cancer (CRC). Despite this, recurrence occurs in ∼60% of patients post-surgery, indicating that the role and optimal type of perioperative systemic therapy has not been fully defined. In the COSMOS-oligo trials, comprising two studies, we are evaluating the potential role of circulating tumor DNA (ctDNA) analysis in clinical decision making and exploring adjuvant therapy strategies for patients with resectable metastatic CRC. The COSMOS-CRC-03 study aims to evaluate the prognostic value of post-operative minimal residual disease as detected by ctDNA and to explore the role of ctDNA in detecting disease recurrence. We plan to assess the predictive accuracy of ctDNA results for recurrence using blood collected 28 days post-surgery. We will additionally explore whether regular post-operative ctDNA test can detect recurrence earlier than standard imaging. Post-operative adjuvant therapy will not be administered to ctDNA-negative patients. The complementary AURORA trial is a randomized phase II study designed to test whether post-operative mFOLFOXIRI plus bevacizumab is superior to standard mFOLFOX6 for patients with metastatic CRC when the ctDNA status is positive after curative-intent surgery for patients enrolled in the COSMOS-CRC-03 study. Both studies will only include patients with resectable distant metastases of CRC. We designed these studies to stratify patients based on the results of a ctDNA assay and to determine the optimal treatment for patients at the highest risk for recurrence.
Keywords: adjuvant chemotherapy; colorectal cancer; ctDNA; liver metastasis; oligometastasis; mFOLFOXIRI plus bevacizumab

Yang, JJ., Huang, C., Chen, GY. et al. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer 14, 684 (2014). https://doi.org/10.1186/1471-2407-14-684

A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung | BMC Cancer | Full Text

Sheill, G., Guinan, E., O’Neill, L. et al. Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial. BMC Cancer 20, 321 (2020). https://doi.org/10.1186/s12885-020-06795-4

Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial | BMC Cancer | Full Text