drugset

drugset / Trial / NCT04747951

Total Neoadjuvant Therapy in Rectal Cancer Treatment

NCT04747951 ↗

Phase 4 Unknown 280 enrolled State Scientific Centre of Coloproctology, Russian Federation

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.

Timeline

Start: 2020-10-30
Primary completion: 2023-10-30
Completion: 2023-11-01

Publications

Background Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.
Background Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21.
Background Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Capecitabine	Small molecule	1650 mg/m2	Oral
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous
Background	l-LV	Unknown	400 mg/m2	Intravenous

Indications