First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
1 other identifier
interventional
65
1 country
37
Brief Summary
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.
- safety of the treament,
- rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
- survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
- rectal tumor response rate (CT scan, MRI and endocopy),
- metastasis response rate,
- disease free survival after complete resection (of primitive tumor and metastases),
- progression free survival (local or distal),
- overall survival, quality of life (QLQ-C30 + CR 29).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
Typical duration for phase_2
37 active sites
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
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 2, 2012
CompletedFirst Posted
Study publicly available on registry
August 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 30, 2020
February 1, 2018
3.8 years
April 2, 2012
March 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor control rate of the primary tumor and metastasis
The tumor control rate of the primary site and metastasis is defined as Complete response or Partial response or stability according to RECIST 1.1 criteria
4 months
Secondary Outcomes (5)
Toxicity of the treatment
Up to 4 months after Last Patient First Visit
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)
4 months
survival without local failure (radiological or clinical progression of the rectal cancer or local complication)
Up to 4 months after Last Patient First Visit
rectal tumor response rate (CT scan, MRI and endocopy)
4 months
metastasis response rate
4 months
Study Arms (1)
single arm study/ non randomized trial
OTHERFOLFORINOX
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven adenocarcinoma of the rectum, the lower pole less than 15 cm from the anal verge
- Patient should not have receive any treatment for cancer
- Synchronous metastases with unresectable hepatic and/or lung localization or uncertain resectability (potentially resectable)
- Measurable lesions by RECIST 1.1 (metastasis and primary cancer of the rectum)
- Age ≥ 18 years
- WHO ≤ 2
- ANC ≥ 1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, creatinine clearance ≥ 60 mL/min
- Hemoglobin ≥ 10 g /dL
- Signed informed consent
You may not qualify if:
- Rectal Cancer in occlusion requiring surgery or a prosthesis in emergency
- Rectal bleeding severe and active
- Prior pelvic irradiation
- History of cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix treated curatively and other cancers treated curatively if they do not relapse over 3 years,
- Hepatic impairment (total bilirubin\> 1.5 x upper limit of normal (ULN) and serum albumin \<25g / L); known Gilbert's disease
- Uncontrolled severe infection,
- Severe pain (VAS\> 5/10) uncontrollable by opioid therapy
- Symptomatic sensorimotor peripheral neuropathy
- Pregnant or lactating patients or patient of both sexes with childbearing potential and not using adequate contraception method
- Patient receiving or having received an experimental therapy within 4 weeks prior to enter into the study or participating in another clinical study of other experimental drugs
- Known hypersensitivity to any component of the treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
CHU
Amiens, France
CHU
Angers, France
CH
Avignon, France
CH
Beauvais, France
CHU
Besançon, France
CH
Béziers, France
Avicennes
Bobigny, France
CHU - Ht Lévêque
Bordeaux, France
Institut Bergonie
Bordeaux, France
CHU d'Estaing
Clermont-Ferrand, France
Colmar Ch
Colmar, 68024, France
Centre G.F. Leclerc
Dijon, France
CHU
Dijon, France
Polyclinique
Francheville, France
CHD Vendée
La Roche-sur-Yon, France
Clinique Victor Hugo
Le Mans, France
CHRU - Hôpital Huriez
Lille, France
CHU La Timone
Marseille, France
Ipc - Cac
Marseille, France
CH Layne
Mont-de-Marsan, France
Centre Cahterine de Sienne
Nantes, France
Polyclinique le Languedoc
Narbonne, France
CH Georges Menon
Niort, France
CHR - Gasto
Orléans, France
AP - HP - Pitié Salpêtrière
Paris, France
CH
Pau, France
CH
Perpignan, France
CHU
Rouen, France
CH Le Foll
Saint-Brieuc, France
Clinique Armoricaine
Saint-Brieuc, France
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, France
CH Robert Morlevat
Semur-en-Auxois, France
CAC
Strasbourg, France
Polyclinique de l'Ormeau
Tarbes, France
Hôpitaux du Leman
Thonon-les-Bains, France
Clinique Saint Jean du Languedoc
Toulouse, France
CHRU Trousseau
Tours, France
Related Publications (1)
Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.
PMID: 30343254RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Baptiste BACHET, Dr
CHU de La Pitié Salpetrière - APHP
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2012
First Posted
August 28, 2012
Study Start
April 1, 2012
Primary Completion
January 1, 2016
Study Completion
October 1, 2016
Last Updated
March 30, 2020
Record last verified: 2018-02