First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

Adenocarcinoma of Rectum Clinical Trial

Official title:

Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674309
• Other study ID #: FFCD 1102
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: October 2016

Study information

• Verified date: February 2018
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Description:

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Rectum
• Rectal Neoplasms

Intervention

Drug:
• FOLFORINOX
INTRAVENOUS administration

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Toxicity of the treatment	Number of patients presenting the main toxicities during the study	Up to 4 months after Last Patient First Visit
Secondary	rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)	The rate is defined as the clinical progression or a radiological progression of the rectum cancer or a local complication due to the treatment or due to the progression	4 months
Secondary	survival without local failure (radiological or clinical progression of the rectal cancer or local complication)	The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death	Up to 4 months after Last Patient First Visit
Secondary	rectal tumor response rate (CT scan, MRI and endocopy)	The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria	4 months
Secondary	metastasis response rate	The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria	4 months