Timing of start of systemic treatment in patients with asymptomatic metastasized pancreatic cancer (TIMEPAN): a protocol of a multicenter prospective patient preference non-randomized trial

References

• Park W, Chawla A, O'Reilly EM. Pancreatic cancer: a review. JAMA. 2021;326(9):851–862. doi:10.1001/jama.2021.13027.
   PubMed Web of Science ®Google Scholar
• Di Gioia D, Stieber P, Schmidt GP, et al. Early detection of metastatic disease in asymptomatic breast cancer patients with whole-body imaging and defined tumour marker increase. Br J Cancer. 2015;112(5):809–818. doi:10.1038/bjc.2015.8.
   PubMed Web of Science ®Google Scholar
• Chan HP, Liu WS, Liou WS, et al. Comparison of FDG-PET/CT for cancer detection in populations With different risks of underlying malignancy. In Vivo. 2020;34(1):469–478. doi:10.21873/invivo.11797.
   PubMed Web of Science ®Google Scholar
• Daamen LA, Groot VP, Intven MPW, et al. Postoperative surveillance of pancreatic cancer patients. Eur J Surg Oncol. 2019;45(10):1770–1777. doi:10.1016/j.ejso.2019.05.031.
   PubMed Web of Science ®Google Scholar
• Daamen LA, Groot VP, Besselink MG, et al. Detection, treatment, and survival of pancreatic cancer recurrence in The Netherlands: a nationwide analysis. Ann Surg. 2022;275(4):769–775. doi:10.1097/sla.0000000000004093.
   PubMed Web of Science ®Google Scholar
• Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817–1825. doi:10.1056/NEJMoa1011923.
   PubMed Web of Science ®Google Scholar
• Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691–1703. doi:10.1056/NEJMoa1304369.
   PubMed Web of Science ®Google Scholar
• Gourgou-Bourgade S, Bascoul-Mollevi C, Desseigne F, et al. Impact of FOLFIRINOX compared with gemcitabine on quality of life in patients with metastatic pancreatic cancer: results from the PRODIGE 4/ACCORD 11 randomized trial. J Clin Oncol. 2013;31(1):23–29. doi:10.1200/jco.2012.44.4869.
   PubMed Web of Science ®Google Scholar
• Augustinus S, Thurairajah G, Besselink MG, et al. Delayed versus immediate start of chemotherapy in asymptomatic patients with advanced cancer: a meta-analysis. Oncologist. 2023;17:oyad235. doi:10.1093/oncolo/oyad235.
   Web of Science ®Google Scholar
• Ghaferi AA, Schwartz TA, Pawlik TM. STROBE reporting guidelines for observational studies. JAMA Surg. 2021;156(6):577–578. doi:10.1001/jamasurg.2021.0528.
   PubMed Web of Science ®Google Scholar
• Schwartz LH, Litière S, de Vries E, et al. RECIST 1.1-Update and clarification: from the RECIST committee. Eur J Cancer. 2016;62:132–137. doi:10.1016/j.ejca.2016.03.081.
   PubMed Web of Science ®Google Scholar
• Coebergh van den Braak RRJ, van Rijssen LB, van Kleef JJ, et al. Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative. Acta Oncol. 2018;57(2):195–202. doi:10.1080/0284186x.2017.1346381.
   PubMed Web of Science ®Google Scholar
• Aaronson NK, Ahmedzai S, Bergman B, et al. The european organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–376. doi:10.1093/jnci/85.5.365.
   PubMed Web of Science ®Google Scholar
• Eaton AA, Karanicolas P, MChir CDJ, et al. Psychometric validation of the EORTC QLQ-PAN26 pancreatic cancer module for assessing health related quality of life after pancreatic resection. J Pancreas. 2017;18(1):19–25.
   Google Scholar
• Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–1736. doi:10.1007/s11136-011-9903-x.
   PubMed Web of Science ®Google Scholar
• Services USDoHaH. Common Terminology Criteria for Adverse Events version 5.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf.
   Google Scholar
• Foundation ER. EQ-5D-3L User Guide. 2018.
   Google Scholar
• Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med. 1990;9(11):1259–1276. doi:10.1002/sim.4780091106.
   PubMed Web of Science ®Google Scholar
• Chesnaye NC, Stel VS, Tripepi G, et al. An introduction to inverse probability of treatment weighting in observational research. Clin Kidney J. 2022;15(1):14–20. doi:10.1093/ckj/sfab158.
   PubMed Web of Science ®Google Scholar
• Cancer. 2023. www.cancer.net
   Google Scholar
• Meropol NJ, Egleston BL, Buzaglo JS, et al. Cancer patient preferences for quality and length of life. Cancer. 2008;113(12):3459–3466. doi:10.1002/cncr.23968.
   PubMed Web of Science ®Google Scholar
• Raptis DA, Fessas C, Belasyse-Smith P, et al. Clinical presentation and waiting time targets do not affect prognosis in patients with pancreatic cancer. Surgeon. 2010;8(5):239–246. doi:10.1016/j.surge.2010.03.001.
   PubMed Web of Science ®Google Scholar
• Gobbi PG, Bergonzi M, Comelli M, et al. The prognostic role of time to diagnosis and presenting symptoms in patients with pancreatic cancer. Cancer Epidemiol. 2013;37(2):186–190. doi:10.1016/j.canep.2012.12.002.
   PubMed Web of Science ®Google Scholar
• Augustinus S, Laarhoven H, Cirkel G, et al. Timing of onset of systemic treatment in asymptomatic patients with metastatic pancreatic cancer: an international expert survey and case-vignette study. J Clin Oncol. 2022;40(16_suppl):e16256–e16256. 40: doi:10.1200/JCO.2022.40.16_suppl.e16256.
   Web of Science ®Google Scholar
• Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993;118(8):622–629. doi:10.7326/0003-4819-118-8-199304150-00009.
   PubMed Web of Science ®Google Scholar
• Pijnappel EN, Dijksterhuis WPM, Sprangers MAG, et al. The fear of cancer recurrence and progression in patients with pancreatic cancer. Support Care Cancer. 2022;30(6):4879–4887. doi:10.1007/s00520-022-06887-w.
   PubMed Web of Science ®Google Scholar
• Chapman SJ, Shelton B, Mahmood H, et al. Discontinuation and non-publication of surgical randomised controlled trials: observational study. BMJ. 2014;349(dec09 1):g6870–g6870. Dec 9 doi:10.1136/bmj.g6870.
   PubMed Web of Science ®Google Scholar
• McDonald AM, Knight RC, Campbell MK, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7(1):9. doi:10.1186/1745-6215-7-9.
   PubMed Web of Science ®Google Scholar
• Lindström D, Sundberg-Petersson I, Adami J, et al. Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial. Contemp Clin Trials. 2010;31(1):22–26. doi:10.1016/j.cct.2009.09.003.
   PubMed Web of Science ®Google Scholar
• Gollhofer SM, Wiskemann J, Schmidt ME, et al. Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy. BMC Cancer. 2015;15(1):186. doi:10.1186/s12885-015-1213-1.
   PubMed Web of Science ®Google Scholar
• Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015;34(28):3661–3679. doi:10.1002/sim.6607.
   PubMed Web of Science ®Google Scholar
• Brewin CR, Bradley C. Patient preferences and randomised clinical trials. BMJ. 1989;299(6694):313–315. doi:10.1136/bmj.299.6694.313.
   PubMed Web of Science ®Google Scholar
• Silverman WA, Altman DG. Patients’ preferences and randomised trials. Lancet. 1996;347(8995):171–174. doi:10.1016/s0140-6736(96)90347-5.
   PubMed Web of Science ®Google Scholar