PRABITAS study design: a pragmatic, randomized phase III trial of bi-weekly versus conventional trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer

Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) is the established therapy for refractory metastatic colorectal cancer, but there are concerns regarding the regimen's complexity and hematotoxic effects, especially for patients with organ dysfunction, comorbidities, or a reduced performance status-groups often excluded from conventional clinical trials. Preliminary studies demonstrated that bi-weekly FTD/TPI + BEV may mitigate these hematotoxic effects compared with the conventional schedule without compromising efficacy. No clinical trials, however, have directly compared these two regimens. Therefore, we initiated the PRABITAS trial, a multicenter, randomized, phase III non-inferiority trial, to evaluate the efficacy and safety of bi-weekly FTD/TPI + BEV compared with conventional FTD/TPI + BEV. This was designed as a pragmatic trial, a novel approach in clinical trials aiming to aid decision-making in daily practice by mimicking real-world clinical settings. The PRABITAS trial incorporates minimal eligibility criteria to include a more representative patient population, allows flexibility in intervention adherence and assessment, and employs streamlined data collection to reduce the burden on both patients and healthcare providers. The primary endpoint is overall survival in the intention-to-treat population. Launched in December 2023, the trial aimed to enroll a total of 890 patients.

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Publication Details

Journal
ESMO Gastrointestinal Oncology
Published
2024-08-30
DOI
https://doi.org/10.1016/j.esmogo.2024.100090
Citations
1
Primary Topic
Colorectal Cancer Treatments and Studies
Type
article
Field-Weighted Citation Impact
0.28

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article

PRABITAS study design: a pragmatic, randomized phase III trial of bi-weekly versus conventional trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer

Hiroyuki Takeda, Takatou Yomoda, Hiroshi Matsuoka, Kenta Murotani et al.
1 citations
ESMO Gastrointestinal Oncology
Colorectal Cancer Treatments and Studies
0.28
article

PRABITAS study design: a pragmatic, randomized phase III trial of bi-weekly versus conventional trifluridine/tipiracil plus bevacizumab for metastatic colorectal cancer

Hiroyuki Takeda, Takatou Yomoda, Hiroshi Matsuoka, Kenta Murotani, Kentaro Sawada, Toshiki Masuishi, Masahiro Tajika, Masashi Ando, M. Asayama, Yosuke Kito, A. Makiyama, Takaya Shimura, K. Muro, Yuta Okumura, Hiroya Taniguchi, Tomoki Sakakida, Mitsuru Yokota, Akira Mishima, Y. Suwa, Chiho Kudo, Masahide Yamamoto, Seiichiro Mitani, H. Mushiake, Yaoko Takano, Kei Ogawa
article en
1 citations

Abstract

Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) is the established therapy for refractory metastatic colorectal cancer, but there are concerns regarding the regimen's complexity and hematotoxic effects, especially for patients with organ dysfunction, comorbidities, or a reduced performance status-groups often excluded from conventional clinical trials. Preliminary studies demonstrated that bi-weekly FTD/TPI + BEV may mitigate these hematotoxic effects compared with the conventional schedule without compromising efficacy. No clinical trials, however, have directly compared these two regimens. Therefore, we initiated the PRABITAS trial, a multicenter, randomized, phase III non-inferiority trial, to evaluate the efficacy and safety of bi-weekly FTD/TPI + BEV compared with conventional FTD/TPI + BEV. This was designed as a pragmatic trial, a novel approach in clinical trials aiming to aid decision-making in daily practice by mimicking real-world clinical settings. The PRABITAS trial incorporates minimal eligibility criteria to include a more representative patient population, allows flexibility in intervention adherence and assessment, and employs streamlined data collection to reduce the burden on both patients and healthcare providers. The primary endpoint is overall survival in the intention-to-treat population. Launched in December 2023, the trial aimed to enroll a total of 890 patients.

ESMO Gastrointestinal OncologyVol. 5
Kurume University (JP), Fujita Health University (JP), St. Marianna University School of Medicine (JP), Yokohama City University Medical Center (JP), National Kyushu Medical Center (JP), Nagoya City University (JP), Toyama Prefectural Central Hospital (JP), Kurashiki Central Hospital (JP), National Hospital Organization Kyushu Cancer Center (JP), Kurume University Medical Center (JP), Gifu University Hospital (JP), Kushiro Rosai Hospital (JP), Omuta hospital (JP), Ishikawa Prefectural Central Hospital (JP), Saitama Cancer Center (JP), Aichi Cancer Center (JP), Saiseikai Ibaraki Hospital (JP), Southern Tohoku General Hospital (JP), Tottori University (JP), Yokohama City University (JP), Kindai University (JP)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Taiho Pharmaceutical, Seagen, Daiichi-Sankyo, Astellas Pharma, Yakult Honsha, Ono Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Bayer Yakuhin, Daiichi Sankyo Europe
Good health and well-being
Openalex Percentile: Top 36%
Colorectal Cancer Treatments and Studies
0.28
DOIOpen Access PDFOpenAlex
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