GRECCAR8: IMPACT ON SURVIVAL OF THE PRIMARY TUMOR RESECTION IN RECTAL CANCER WITH UNRESECTABLE SYNCHRONOUS METASTASIS A RANDOMIZED MULTICENTRE STUDY

Trial Overview

Acronym	GRECCAR8
Number	ClinicalTrial.gov: NCT02314182
Protocol Link	http://bmccancer.biomedcentral.com/articles/10.1186/s12885-015-1060-0
Public Trial Registry Link	https://clinicaltrials.gov/ct2/show/NCT02314182?term=greccar8&rank=1
Status	Open/recruiting
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

This study is a multicentre randomized open-label controlled trial aimed to evaluate the impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis. Primary outcome will be overall survival which will be measured from the date of randomization to the date of death or to the end of follow-up (2 years).

Chief Investigator

Eddy Cotte
MD, PhD

Profile Link

Lead Centre

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
165 Chemin du Grand Revoyet
Pierre Benite
69310
France

Website

Collaboration and Funding

Collaborative Sites

1. Hôpital Saint-André - Groupe hospitalier Saint-André - CHU de Bordeaux
1 Rue Jean Burguet
Bordeaux
33000
France
Website

2. Montpellier Cancer Institute
208 Avenue des Apothicaires
Monpellier
34298
France
Contact: Philippe Rouanet
Website

3. CHU Charles Nicolle
1 Rue de Germont
Rouen
76031
France
Contact: Jean-Jacques Tuech
Website

4. APHP Beaujon
100 Boulevard du G?n?ral Leclerc
Clichy
92110
France
Contact: Yves Panis
Website

5. CHU Amiens-Picardie Site Nord
1 Place Victor Pauchet
Amiens
80000 ,
France
Website

6. Hôpital Jean-Minjoz
3 Boulevard A. Fleming
Besançon Cedex
25030
France
Website

7. Institut Bergonié
229 Cours de l'Argonne
Bordeaux
33000
France
Website

8. CHU Estaing
1 Rue Lucie Aubrac,
Clermont-Ferrand
63100
France
Website

9. CHU Bocage - Centre hospitalier universitaire de Dijon
14 Rue Paul Gaffarel
Dijon
21000
France
Website

10. Centre Georges-François Leclerc (Dijon)
1 Rue du Professeur Marion
Dijon
21000
France
Website

11. Hôpital Albert MICHALLON (Centre Hospitalier Universitaire)
BOULEVARD DE LA CHANTOURNE
LA Tronche
38700
France
Website

12. Hospital Claude Huriez
1 Place de Verdun
Lille
59000
France
Website

13. Hôpital de la Timone
264 Rue Saint-Pierre
Marseille
13385
France
Website

14. Institut Paoli-Calmettes
232 Boulevard de Sainte-Marguerite
Marseille
13009
France
Website

15. CHU Archet II
151 Route de St Antoine de Ginestière
Nice
06200
France
Website

16. Lariboisière Hospital
2 Rue Ambroise Paré
Paris
75475
France
Website

17. Hôpital Saint-Louis
1 Avenue Claude Vellefaux
Paris
75010
France
Website

18. Saint Joseph's Hospital
186 Rue Raymond Losserand
Paris
75014
France
Website

19. Hôpital Saint-Antoine
184 Rue du Faubourg Saint-Antoine,
Paris
75012
France
Website

20. CHU de Poitiers
2 Rue de la Milétrie
Poitiers
86021
France
Website

Funding Sponsors

Additional Information

Full Research Summary

Objective:	Compare overall survival rates in patients with rectal cancer and unresectable metastasis, surgically treated or not for their primary rectal tumor.
Aim:	Exclusive systemic chemotherapy is most often used to treat patient with rectal cancer and unresectable metastasis. During this treatment, patients may require emergency surgery to treat complications related to the primary (obstruction, bleeding or perforation). Such unplanned operations are associated with higher operative morbidity and mortality to scheduled procedures for stage IV disease. Many surgeons have advocated resection of the primary mainly to avoid these complications however this surgery may delay the start of chemotherapy. Some studies reported that resection of the primary in case of unresectable metastatic disease prolonged survival. These studies were non-randomized and the majority were single-centre and retrospective. The major drawback of these non-randomized studies was that the patients selected for surgery were those with a better performance status and better prognosis. Furthermore, the impact of primary tumor resection on quality of life has not been assessed. All published studies included colon and rectal cancers, but the issues are different for these two localizations. Surgery for rectal cancer seems more complex and may result in increased morbidity and postoperative functional disorders (stoma, digestive, sexual, urinary) compared to colonic surgery. On the other hand, symptoms related to the progression of rectal tumor are often severely disabling (pain, rectal syndrome) and difficult to control.
Methods:	This study is a multicentre randomized open-label controlled trial aimed to evaluate the impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis (Figure 1- Flow chart study). Patients will be randomly assigned in a 1:1 ratio to Arm A: primary tumor resection followed by systemic chemotherapy versus Arm B: systemic chemotherapy alone.
Reason for International Trial:	There are advantages and disadvantages with both tumor resection and chemotherapy alone. There is a need to perform a randomized trial evaluating the impact of primary tumor resection on survival in patients with rectal cancers and unresectable synchronous metastases. Moreover, quality of life is a critical aspect of palliative treatments which has never been specifically investigated. Quality of life may be impacted by both the symptoms and complications relating to the rectal cancer itself and by primary tumor resection. Whether or not resection of the primary tumor in palliative care is beneficial remains a clinical dilemma. To date, no randomized trial has assessed the impact of primary tumor resection on overall survival and quality of life in patients with CRC and unresectable metastases. GRECCAR 8 is a dedicated prospective randomized study looking into the specific problem of rectal cancer to evaluate the impact of primary tumor resection in rectal cancer with unresectable metastases.

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Trial Details

GRECCAR8: IMPACT ON SURVIVAL OF THE PRIMARY TUMOR RESECTION IN RECTAL CANCER WITH UNRESECTABLE SYNCHRONOUS METASTASIS A RANDOMIZED MULTICENTRE STUDY

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

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Trial Details

GRECCAR8: IMPACT ON SURVIVAL OF THE PRIMARY TUMOR RESECTION IN RECTAL CANCER WITH UNRESECTABLE SYNCHRONOUS METASTASIS A RANDOMIZED MULTICENTRE STUDY

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Collaboration and Funding

Additional Information

Research

Why join us?

Members

Research

Education

News & Events

About ESCP

Contact Us

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