Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2030

Conditions
Rectal Cancer
Interventions
DRUG

Neoadjuvant Chemoradiotherapy

"5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide.~The CRT regimen consists of the standard algorithms: a total of 5400-5600 cGy of radiation (4500 cGy to the pelvis, with an integrated boost to the primary tumour and involved nodes of 500 cGy followed by an option boost to the primary tumour and involved nodes) delivered in 27-28 fractions, respectively, of 180-200 cGy each over a 5-6 week period."

DRUG

Total Neoadjuvant Therapy

"5-FU is a fluoropyrimidine antimetabolite considered to act primarily as an inhibitor of thymidylate synthase. 5-FU is supplied as a colourless-to-faint yellow solution in 10-mL single use vials. Each 10 mL of solution contains 500 mg 5-FU, with pH adjusted to approximately 9.2 with sodium hydroxide.~Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2- diaminocyclohexane with an oxalate ligand as a leaving group. Platinum content is 48.1% to 50.1%.~All patients received the same chemotherapy (FOLFOX) and long-course chemoradiotherapy (50.4 Gy in 28 fractions) before surgery."

All Listed Sponsors
lead

St. James's Hospital, Ireland

OTHER