NCT04643366

Total Neoadjuvant Therapy With mFOLFOX and Short-course Radiation in Resectable Rectal Cancer

Phase 2 Study of Total Neoadjuvant mFOLFOX and Short-Course Radiotherapy in Resectable Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is phase 2 trial of neoadjuvant therapy and short-course radiotherapy in resectable rectal cancer.

Detailed description

This trial involves 4 cycles of systemic chemotherapy followed by short-course RT with concurrent 5-FU neoadjuvant chemoradiotherapy (CRT) and subsequent consolidation with 4 cycles of systemic chemotherapy prior to surgery or, for those who achieve cCR, the option of non-operative active surveillance.Three-year disease free survival (DFS) defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of clinical complete response (cCR) or date of total mesorectal excision (TME) at surgery (whichever is earlier).

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)
RADIATION	Radiation Therapy	Pelvic Intensity-modulated radiation therapy (IMRT)

Timeline

• Start date: 2021-01-28
• Primary completion: 2028-01-31
• Completion: 2033-01-31
• First posted: 2020-11-25
• Last updated: 2026-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study