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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02087475
Collaborator
(none)
360
Enrollment
1
Location
2
Arms
167
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neoadjuvant therapy arm

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

Drug: Irinotecan

Drug: 5-fluorouracil

Radiation: Local radiotherapy

Procedure: R0 resection
Active Comparator: Adjuvant therapy arm

Surgery -> FOLFIRI * 12 cycles +/- radiotherapy

Drug: Irinotecan

Drug: 5-fluorouracil

Radiation: Local radiotherapy

Procedure: R0 resection

Outcome Measures

Primary Outcome Measures

  1. Progress Free Survival [3 years]

Secondary Outcome Measures

  1. Overall Survival [3 Years]

  2. R0 Resection Rate [6 Month]

  3. Treatment RelatedToxicity [3 Year]

    Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.

  4. Life Quality [3 Years]

    EORTC QoL Questionaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The 6th Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China 510655

Sponsors and Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Ping Lan, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ping Lan, Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02087475
Other Study ID Numbers:
  • SAH 5010 CRC
First Posted:
Mar 14, 2014
Last Update Posted:
Jun 5, 2019
Last Verified:
Jun 1, 2019
Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Recurrence, Local
Recurrence
Fluorouracil
Irinotecan

Study Results

No Results Posted as of Jun 5, 2019