First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
NCT ID: NCT01674309
Last Updated: 2020-03-30
Study Results
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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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2012-04-30
2016-10-31
Brief Summary
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1. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).
2. The secondary objectives are:
* 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).
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Detailed Description
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1. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).
2. The secondary objectives are:
* 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).
3. Inclusion and non inclusion criteria
4. Treatment
5. Follow up
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm study/ non randomized trial
FOLFORINOX
FOLFORINOX
INTRAVENOUS administration
Interventions
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FOLFORINOX
INTRAVENOUS administration
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Jean-Baptiste BACHET, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU de La Pitié Salpetrière - APHP
Locations
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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, , 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
Countries
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References
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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.
Other Identifiers
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FFCD 1102
Identifier Type: -
Identifier Source: org_study_id
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