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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Metastasis; Surgery; Local Neoplasm Recurrence; Effects of Chemotherapy; Colorectal Neoplasms

Treatments: Radiation: Local radiotherapy; Drug: 5-fluorouracil; Procedure: R0 resection; Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT02087475

SAH 5010 CRC

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age:18-80
• ECOG score: 0 or 1
• Histological confirmed of Colorectal Adenocarcinoma
• History of exposure to oxaliplatin
• With local recurrent or metastatic focus
• Tumor resectable confirmed by at less 3 hepatobiliary surgeon
• Informed content acquired

Exclusion criteria

• History of Exposure to Irinotecan
• Received surgery in recently 4 weeks or did not recover from surgery
• Other history of cancer in recent 5 years
• Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
• Women with potential pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Neoadjuvant therapy arm

Experimental group

Description:

FOLFIRI \* 6 cycles +/- radiotherapy -\> surgery -\> FOLFIRI \* 6 cycles

Treatment:

Procedure: R0 resection

Radiation: Local radiotherapy

Drug: Irinotecan

Drug: 5-fluorouracil

Adjuvant therapy arm

Active Comparator group

Description:

Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

Treatment:

Procedure: R0 resection

Radiation: Local radiotherapy

Drug: Irinotecan

Drug: 5-fluorouracil