Clinical trial NCT01674309: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
Official title: Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of Rectum
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Tumor control rate of the primary tumor and metastasis
timeFrame: 4 months
Secondary outcomes:
measure: Toxicity of the treatment
timeFrame: Up to 4 months after Last Patient First Visit
measure: rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)
timeFrame: 4 months
measure: survival without local failure (radiological or clinical progression of the rectal cancer or local complication)
timeFrame: Up to 4 months after Last Patient First Visit
measure: rectal tumor response rate (CT scan, MRI and endocopy)
timeFrame: 4 months
measure: metastasis response rate
timeFrame: 4 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU
city: Angers
country: France
facility: CHU
city: Avignon
country: France
facility: CH
city: Beauvais
country: France
facility: CH
city: Besançon
country: France
facility: CHU
city: Bobigny
country: France
facility: Avicennes
city: Bordeaux
country: France
facility: CHU - Ht Lévêque
city: Bordeaux
country: France
facility: Institut Bergonie
city: Béziers
country: France
facility: CH
city: Clermont Ferrand
country: France
facility: CHU d'Estaing
city: Colmar
country: France
facility: Colmar Ch
city: Dijon
country: France
facility: Centre G.F. Leclerc
city: Dijon
country: France
facility: CHU
city: Francheville
country: France
facility: Polyclinique
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: CHRU - Hôpital Huriez
city: Marseille
country: France
facility: CHU La Timone
city: Marseille
country: France
facility: Ipc - Cac
city: Mont de Marsan
country: France
facility: CH Layne
city: Nantes
country: France
facility: Centre Cahterine de Sienne
city: Narbonne
country: France
facility: Polyclinique le Languedoc
city: Niort
country: France
facility: CH Georges Menon
city: Orléans
country: France
facility: CHR - Gasto
city: Paris
country: France
facility: AP - HP - Pitié Salpêtrière
city: Pau
country: France
facility: CH
city: Perpignan
country: France
facility: CH
city: Rouen
country: France
facility: CHU
city: Saint Brieuc
country: France
facility: CH Le Foll
city: Saint Brieuc
country: France
facility: Clinique Armoricaine
city: Saint Jean De Luz
country: France
facility: Polyclinique Côte Basque Sud
city: Semur en Auxois
country: France
facility: CH Robert Morlevat
city: Strasbourg
country: France
facility: CAC
city: Tarbes
country: France
facility: Polyclinique de l'Ormeau
city: Thonon Les Bains
country: France
facility: Hôpitaux du Leman
city: Toulouse
country: France
facility: Clinique Saint Jean du Languedoc
city: Tours
country: France
facility: CHRU Trousseau
Study officials:
affiliation: CHU de La Pitié Salpetrière - APHP
name: Jean-Baptiste BACHET, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.