Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT02087475
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
  • 5-fluorouracil — DRUG
  • Local radiotherapy — RADIATION
  • R0 resection — PROCEDURE

Study Details

Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.

Key Dates

Start date
Jan 31, 2011
Status verified
Jun 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2024

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant therapy arm
    FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles
  • Active Comparator: Adjuvant therapy arm
    Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

Primary Outcome Measure

Progress Free Survival [ Time Frame: 3 years ]

Central Contacts

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