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

NCT ID: NCT02087475

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms Effects of Chemotherapy Surgery Metastasis Local Neoplasm Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant therapy arm

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

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Local radiotherapy

Intervention Type RADIATION

R0 resection

Intervention Type PROCEDURE

Adjuvant therapy arm

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

Group Type ACTIVE_COMPARATOR

Irinotecan

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Local radiotherapy

Intervention Type RADIATION

R0 resection

Intervention Type PROCEDURE

Interventions

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Irinotecan

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Local radiotherapy

Intervention Type RADIATION

R0 resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Ping Lan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping Lan, MD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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The 6th Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Xiao, MD

Role: CONTACT

+8613711114566

Facility Contacts

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Jian Xiao, MD

Role: primary

+8613711114566

Other Identifiers

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SAH 5010 CRC

Identifier Type: -

Identifier Source: org_study_id

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