Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial

Daniel P. Petrylak, Ronald de Wit, Kim N., Alexandra Drakaki, Cora N. Sternberg, Hiroyuki Nishiyama, Daniel Castellano, Syed A. Hussain, Aude Fléchon, Aristotelis Bamias, Evan Y. Yu, Michiel S. van der Heijden, Nobuaki Matsubara, B. Yа. Alekseev, Andrea Necchi, Lajos Géczi, Yen‐Chuan Ou, Hasan Şenol Çoşkun, Wen-Pin Su, Miriam Hegemann, Ivor Percent, Jae‐Lyun Lee, Marcello Tucci, Andrey Semenov, Fredrik Laestadius, Avivit Peer, Giampaolo Tortora, Sufia Safina, Xavier García del Muro, Alejo Rodríguez‐Vida, İrfan Çiçin, Hakan Harputluoğlu, Ryan C. Widau, Astra M. Liepa, Richard A. Walgren, Oday Hamid, Annamaria H. Zimmermann, Katherine M. Bell‐McGuinn, Thomas Powles, Suet-Lai Shirley Wong, Thean Hsiang Tan, Elizabeth Hovey, Timothy Clay, Siobhan Ng, Annemie Rutten, Jean‐Pascal Machiels, Herlinde Dumez, Susanna Y. Cheng, Kim Nguyen, Cristiano Ferrario, Lisa Sengeloev, Niels Viggo Jensen, Constance Thibault, Brigitte Laguerre, Fredrik Laestadius, Florence Joly, Aude Fléchon, Stéphane Culine, Catherine Becht, Günter Niegisch, Michael Stöckle, Marc‐Oliver Grimm, Georgios Gakis, Wolfgang Schultze‐Seemann, Haralambos Kalofonos, Dimitriοs Mavroudis, Christos N. Papandreou, Vasilis Karavasilis, Aristotelis Bamias, János Révész, Lajos Géczi, Eli Rosenbaum, Raya Leibowitz‐Amit, Daniel Kejzman, Avivit Peer, David Sarid, Giorgio V. Scagliotti, Cora N. Sternberg, Giampaolo Tortora, Sergio Bracarda, Andrea Necchi, Francesco Massari, Takahiro Osawa, Naoto Miyajima, Nobuo Shinohara, Fumimasa Fukuta, Chikara Οhyama, Wataru Obara, Shinichi Yamashita, Yoshihiko Tomita, Koji Kawai, Satoshi Fukasawa, Nobuaki Matsubara, Masafumi Oyama, Junji Yonese, Masayoshi Nagata, Motohide Uemura, Kazuo Nishimura, Mutsushi Kawakita, Hiroyuki Tsunemori

The Lancet · 2017

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Summary

The RANGE trial was a phase 3, double-blind, randomised controlled trial evaluating ramucirumab (a vascular endothelial growth factor receptor 2 inhibitor) combined with docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy. The trial enrolled a large international cohort and compared clinical outcomes between the active treatment and placebo arms, providing evidence on the efficacy and tolerability of this combination regimen in a treatment-refractory population.

UK applicability

If efficacy was demonstrated, findings would inform National Health Service treatment guidelines for urothelial carcinoma; however, applicability depends on trial outcomes, cost-effectiveness within NHS constraints, and whether results are consistent with European regulatory assessments.

Key measures

Clinical efficacy endpoints (likely progression-free survival and/or overall survival), response rates, and adverse event profiles in the ramucirumab-treated versus placebo-treated arms.

Outcomes reported

As suggested by the title, this phase 3 randomised controlled trial measured efficacy and safety outcomes in patients with locally advanced or metastatic urothelial carcinoma receiving ramucirumab plus docetaxel versus placebo plus docetaxel following platinum-based chemotherapy.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s0140-6736(17)32365-6
Catalogue ID
BFmommpjky-nun82k

Topic tags

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