NCT00952029|CompletedPhase 2DMC

Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer

Federation Francophone de Cancerologie Digestive ClinicalTrials.gov

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7 other identifiers

PRODIGE 9FFCD-PRODIGE-9FFCD-0802EU-20912EU-21030EUDRACT-2008-007928-25EUDRACT-2009-017996-11

Study Type

interventional

Target

492

Locations

1 country

Sites

102

Timeline

RegisteredAug 2009

StartedMar 2010

CompletionJan 2018

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

492

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline

Completed

Started Mar 2010

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach

1 country

102 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.8 years study duration

First Submitted

Initial submission to the registry

August 1, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed

7 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

5.8 years

First QC Date

August 1, 2009

Last Update Submit

March 27, 2020

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

Disease-control duration
one year after last patient included

Secondary Outcomes (9)

Objective response rate
one year after last patient is included
Rate of non-hematologic grade 3-4 toxicities (except alopecia)
one year after last patient is included
Overall toxicity rate
one year after last patient is included
Duration of chemotherapy-free interval
one year after last patient is included
Progression-free survival
one year after last patient is included
+4 more secondary outcomes

Study Arms (2)

Maintenance with bevacizumab

EXPERIMENTAL

FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab

Biological: bevacizumabDrug: FOLFIRI regimenDrug: fluorouracilDrug: irinotecan hydrochlorideDrug: leucovorin calcium

No maintenance with bevacizumab

ACTIVE COMPARATOR

FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance

Biological: bevacizumabDrug: FOLFIRI regimenDrug: fluorouracilDrug: irinotecan hydrochlorideDrug: leucovorin calcium