Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Sponsor
Salah Azaïz Cancer Institute
Study ID
NCT05868317
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) — DRUG
    Induction chemotherapy with six cycles of modified 5 fluorouracil,oxaliplatin and irinotecan followed by short course radiotherapy (RT) (5x5 Gy), then two cycles of 5 fluorouracil and oxaliplatin based chemotherapy and surgery will be performed 6 to 8 weeks after completion of RT. After surgery , continuation of chemotherapy with 4 cycles of 5 fluorouracil and oxaliplatin regardless of pathological response
  • Radiotherapy — RADIATION
    Short Course Radiotherapy

Study Details

A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma

Key Dates

Start date
Nov 1, 2020
Status verified
May 2023
Primary completion
Nov 30, 2022
Completion
Nov 30, 2023

Study Design

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

Arms

  • Experimental: Induction CT followed by short course RT
    Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.

Primary Outcome Measure

Pathologic complete response [ Time Frame: 1 month after surgery ]

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