TY - JOUR
T1 - Stereotactic ablative radiotherapy or best supportive care in patients with localized pancreatic cancer not receiving chemotherapy and surgery (PANCOSAR)
T2 - a nationwide multicenter randomized controlled trial according to a TwiCs design
AU - Doppenberg, D.
AU - Besselink, M. G.
AU - van Eijck, C. H. J.
AU - Intven, M. P. W.
AU - Koerkamp, B. Groot
AU - Kazemier, G.
AU - van Laarhoven, H. W. M.
AU - Meijerink, M.
AU - Molenaar, I. Q.
AU - Nuyttens, J. J. M. E.
AU - van Os, R.
AU - van Santvoort, H. C.
AU - van Tienhoven, G.
AU - Verkooijen, H. M.
AU - Versteijne, E.
AU - Wilmink, J. W.
AU - Lagerwaard, F. J.
AU - Bruynzeel, A. M. E.
N1 - Funding Information: The sponsor/investigator has a liability insurance which is in accordance with article 7, subsection 6 of the ‘Wet medisch-wetenschappelijk onderzoek met mensen’, hereafter WMO. The sponsor (also) has an insurance which is in accordance with the legal requirements in the Netherlands (Article 7 WMO and the Measure regarding Compulsory Insurance for Clinical Research in Humans of 23th June 2003). This insurance provides cover for damage to research subjects through injury or death caused by the study. 1. € 650.000,-- (i.e. six hundred and fifty thousand Euro) for death or injury for each subject who participates in the Research; 2. € 5.000.000,-- (i.e. five million Euro) for death or injury for all subjects who participate in the Research; 3. € 7.500.000,-- (i.e. seven million five hundred thousand Euro) for the total damage incurred by the organization for all damage disclosed by scientific research for the Sponsor as ‘verrichter’ in the meaning of said Act in each year of insurance coverage. The insurance applies to the damage that becomes apparent during the study or within 4 years after the end of the study. After completion of the study and analysis of the data, the results will be made publicly with- out restriction, independent of the outcome. The results will be submitted for publication to an international peer-reviewed journal. Directed by the principal investigators, the coordinating-, local- and co-investigators, as mentioned on the cover page, will be co-authors of resulting publications. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Background: Significant comorbidities, advanced age, and a poor performance status prevent surgery and systemic treatment for many patients with localized (non-metastatic) pancreatic ductal adenocarcinoma (PDAC). These patients are currently treated with ‘best supportive care’. Therefore, it is desirable to find a treatment option which could improve both disease control and quality of life in these patients. A brief course of high-dose high-precision radiotherapy i.e. stereotactic ablative body radiotherapy (SABR) may be feasible. Methods: A nationwide multicenter trial performed within a previously established large prospective cohort (the Dutch Pancreatic cancer project; PACAP) according to the ‘Trial within cohorts’ (TwiCs) design. Patients enrolled in the PACAP cohort routinely provide informed consent to answer quality of life questionnaires and to be randomized according to the TwiCs design when eligible for a study. Patients with localized PDAC who are unfit for chemotherapy and surgery or those who refrain from these treatments are eligible. Patients will be randomized between SABR (5 fractions of 8 Gy) with ‘best supportive care’ and ‘best supportive care’ only. The primary endpoint is overall survival from randomization. Secondary endpoints include preservation of quality of life (EORTC-QLQ-C30 and -PAN26), NRS pain score response and WHO performance scores at baseline, and, 3, 6 and 12 months. Acute and late toxicity will be scored using CTCAE criteria version 5.0: assessed at baseline, day of last fraction, at 3 and 6 weeks, and 3, 6 and 12 months following SABR. Discussion: The PANCOSAR trial studies the added value of SBRT as compared to ‘best supportive care’ in patients with localized PDAC who are medically unfit to receive chemotherapy and surgery, or refrain from these treatments. This study will assess whether SABR, in comparison to best supportive care, can relieve or delay tumor-related symptoms, enhance quality of life, and extend survival in these patients. Trial registration: Clinical trials, NCT05265663, Registered March 3 2022, Retrospectively registered.
AB - Background: Significant comorbidities, advanced age, and a poor performance status prevent surgery and systemic treatment for many patients with localized (non-metastatic) pancreatic ductal adenocarcinoma (PDAC). These patients are currently treated with ‘best supportive care’. Therefore, it is desirable to find a treatment option which could improve both disease control and quality of life in these patients. A brief course of high-dose high-precision radiotherapy i.e. stereotactic ablative body radiotherapy (SABR) may be feasible. Methods: A nationwide multicenter trial performed within a previously established large prospective cohort (the Dutch Pancreatic cancer project; PACAP) according to the ‘Trial within cohorts’ (TwiCs) design. Patients enrolled in the PACAP cohort routinely provide informed consent to answer quality of life questionnaires and to be randomized according to the TwiCs design when eligible for a study. Patients with localized PDAC who are unfit for chemotherapy and surgery or those who refrain from these treatments are eligible. Patients will be randomized between SABR (5 fractions of 8 Gy) with ‘best supportive care’ and ‘best supportive care’ only. The primary endpoint is overall survival from randomization. Secondary endpoints include preservation of quality of life (EORTC-QLQ-C30 and -PAN26), NRS pain score response and WHO performance scores at baseline, and, 3, 6 and 12 months. Acute and late toxicity will be scored using CTCAE criteria version 5.0: assessed at baseline, day of last fraction, at 3 and 6 weeks, and 3, 6 and 12 months following SABR. Discussion: The PANCOSAR trial studies the added value of SBRT as compared to ‘best supportive care’ in patients with localized PDAC who are medically unfit to receive chemotherapy and surgery, or refrain from these treatments. This study will assess whether SABR, in comparison to best supportive care, can relieve or delay tumor-related symptoms, enhance quality of life, and extend survival in these patients. Trial registration: Clinical trials, NCT05265663, Registered March 3 2022, Retrospectively registered.
KW - MRgRT
KW - Pancreatic cancer
KW - Quality-of-life
KW - Radiotherapy
KW - SABR
KW - SBRT
UR - http://www.scopus.com/inward/record.url?scp=85145127890&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12885-022-10419-4
DO - https://doi.org/10.1186/s12885-022-10419-4
M3 - Article
C2 - 36581914
SN - 1471-2407
VL - 22
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 1363
ER -