Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

January 7, 2025

Primary Completion Date

December 27, 2029

Study Completion Date

December 27, 2029

Conditions
Rectal CancerTotal Neoadjuvant TreatmentNeoadjuvant TherapyRadiotherapyChemotherapyOrgan PreservationRadiotherapy Side EffectChemotherapy Side EffectsChemoradiotherapyLow Anterior Resection SyndromeQuality of Life
Interventions
RADIATION

Radiation Therapy

Radiation therapy (RT) is administered at a dose of 2 Gy per day for a total dose of 50 Gy delivered to the pelvis. This is done throughout 5 to 6 weeks.

DRUG

Chemoradiotherapy

"Capecitabine: 825 mg/m² twice daily, prescribed 1-5 days per week, for 5 weeks during RT.~Or Bolus 5-FU regimen: 5-fluorouracil (5-FU) 400 mg/m2/day intravenously, administered on days 1-4 and 33-35. Calcium folinate (folinic acid) 20 mg/m2/day intravenously on days 1-4 and 33-35."

DRUG

Consolidation Chemotherapy

"XELOX: Oxaliplatin 130 mg/m² (day 1) + capecitabine 1000 mg/m² (days 1-14), every 3 weeks for 4 cycles.~Or FOLFOX: Oxaliplatin - 85 mg/m2 intravenously (2-hour infusion), drip for 1 day. Calcium folinate (folinic acid) - 400 mg/m2/d. intravenously (2-hour infusion), started on day 1. F(5-fluorouracil) - 400 mg/m2/d. intravenously (bolus), started on day 1. Repeat every 2 weeks for 6 times."

PROCEDURE

Surgery

Transabdominal Resection: Abdominoperineal resection, low anterior resection, or coloanal anastomosis using total mesorectal excision.

OTHER

Part two

Standard treatment protocols and follow-up procedures are implemented in clinical practice.

OTHER

Adjuvant treatment

If indicated, adjuvant therapy will be administered as usual in clinical practice.

Trial Locations (1)

08660

RECRUITING

Nacional Cancer Institute, Vilnius

All Listed Sponsors
collaborator

Vilnius University

OTHER

collaborator

Tomas Poskus, Faculty of Medicine, Vilnius University

UNKNOWN

collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

collaborator

Research Council of Lithuania

OTHER

lead

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

OTHER