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

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).

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of Rectum
• Intervention / Treatment: Drug: FOLFORINOX

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

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU
  • Angers, France
    • CHU
  • Avignon, France
    • CH
  • Beauvais, France
    • CH
  • Besançon, France
    • CHU
  • Bobigny, France
    • Avicennes
  • Bordeaux, France
    • Institut Bergonié
  • Bordeaux, France
    • CHU - Ht Lévêque
  • Béziers, France
    • CH
  • Clermont Ferrand, France
    • CHU d'Estaing
  • Colmar, France, 68024
    • Colmar CH
  • Dijon, France
    • CHU
  • Dijon, France
    • Centre G.F. Leclerc
  • Francheville, France
    • Polyclinique
  • La Roche Sur Yon, France
    • CHD Vendee
  • Le Mans, France
    • Clinique Victor Hugo
  • Lille, France
    • CHRU - Hôpital Huriez
  • Marseille, France
    • CHU La Timone
  • Marseille, France
    • Ipc - Cac
  • Mont de Marsan, France
    • CH Layné
  • Nantes, France
    • Centre Cahterine de Sienne
  • Narbonne, France
    • Polyclinique Le Languedoc
  • Niort, France
    • CH Georges Menon
  • Orléans, France
    • CHR - Gasto
  • Paris, France
    • AP - HP - Pitié Salpêtrière
  • Pau, France
    • CH
  • Perpignan, France
    • CH
  • Rouen, France
    • CHU
  • Saint Brieuc, France
    • CH Le Foll
  • Saint Brieuc, France
    • Clinique Armoricaine
  • Saint Jean De Luz, France
    • Polyclinique Côte Basque Sud
  • Semur en Auxois, France
    • Ch Robert Morlevat
  • Strasbourg, France
    • CAC
  • Tarbes, France
    • Polyclinique de l'Ormeau
  • Thonon Les Bains, France
    • Hopitaux du Leman
  • Toulouse, France
    • Clinique Saint Jean du Languedoc
  • Tours, France
    • CHRU Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm study/ non randomized trial; FOLFORINOX	Drug: FOLFORINOX; INTRAVENOUS administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity of the treatment	Number of patients presenting the main toxicities during the study	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)	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
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
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
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

Collaborators and Investigators

• Sponsor: Federation Francophone de Cancerologie Digestive
• Investigators: Principal Investigator: Jean-Baptiste BACHET, Dr, CHU de La Pitié Salpetrière - APHP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: FFCD 1102