Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT05253846
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Irinotecan — DRUG
    chemotherapy treatment
  • Oxaliplatin — DRUG
    chemotherapy treatment
  • Lederfolin — DRUG
    treatment
  • 5-Fluorouracil — DRUG
    chemotherapy treatment
  • Short-course radiotherapy — RADIATION
    RT
  • TME — PROCEDURE
    surgery

Study Details

The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.

Key Dates

Start date
Jan 25, 2022
Status verified
Jun 2025
Primary completion
Jan 5, 2025
Completion
Oct 30, 2028

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SCRT--> FOLFOXIRI--> SURGERY
    SHORT-COURSE RT FOLFOXIRI * IRINOTECAN 165 mg/sqm iv over 60 minutes, day 1 followed by * OXALIPLATIN 85 mg/sqm iv over 2 hours, day 1 in two-way with * LEDERFOLIN 200 mg/sqm iv over 2 hours, day 1 followed by * 5-FLUOROURACIL 3200 mg/sqm 48 h-continuous infusion, starting on day 1. The chemotherapy treatment will be repeated every 2 weeks up to 8 cycles. Surgery with TME should be performed after 4 weeks after the last cycle of chemotherapy

Primary Outcome Measure

complete pathologic response (pCR) [ Time Frame: 30 months ]

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