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

Primary Purpose

Adenocarcinoma of Rectum

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFORINOX
Sponsored by
Federation Francophone de Cancerologie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of Rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • CHU
  • CH
  • CH
  • CHU
  • Avicennes
  • CHU - Ht Lévêque
  • Institut Bergonie
  • CH
  • CHU d'Estaing
  • Colmar Ch
  • Centre G.F. Leclerc
  • CHU
  • Polyclinique
  • CHD Vendée
  • Clinique Victor Hugo
  • CHRU - Hôpital Huriez
  • CHU La Timone
  • Ipc - Cac
  • CH Layne
  • Centre Cahterine de Sienne
  • Polyclinique le Languedoc
  • CH Georges Menon
  • CHR - Gasto
  • AP - HP - Pitié Salpêtrière
  • CH
  • CH
  • CHU
  • CH Le Foll
  • Clinique Armoricaine
  • Polyclinique Côte Basque Sud
  • CH Robert Morlevat
  • CAC
  • Polyclinique de l'Ormeau
  • Hôpitaux du Leman
  • Clinique Saint Jean du Languedoc
  • CHRU Trousseau

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm study/ non randomized trial

Arm Description

FOLFORINOX

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Toxicity of the treatment
Number of patients presenting the main toxicities during the study
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
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
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
metastasis response rate
The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria

Full Information

First Posted
April 2, 2012
Last Updated
March 27, 2020
Sponsor
Federation Francophone de Cancerologie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT01674309
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1). 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. The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1). 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). Inclusion and non inclusion criteria Treatment Follow up

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of Rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm study/ non randomized trial
Arm Type
Other
Arm Description
FOLFORINOX
Intervention Type
Drug
Intervention Name(s)
FOLFORINOX
Intervention Description
INTRAVENOUS administration
Primary Outcome Measure Information:
Title
Tumor control rate of the primary tumor and metastasis
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Toxicity of the treatment
Description
Number of patients presenting the main toxicities during the study
Time Frame
Up to 4 months after Last Patient First Visit
Title
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)
Description
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
Time Frame
4 months
Title
survival without local failure (radiological or clinical progression of the rectal cancer or local complication)
Description
The survival time is defined as the time between the patient's inclusion and the time of the local failure or patient's death
Time Frame
Up to 4 months after Last Patient First Visit
Title
rectal tumor response rate (CT scan, MRI and endocopy)
Description
The rectal tumor response rate is the Complete response or the Partial response of the rectal tumor using RECIST 1.1 criteria
Time Frame
4 months
Title
metastasis response rate
Description
The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste BACHET, Dr
Organizational Affiliation
CHU de La Pitié Salpetrière - APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Amiens
Country
France
Facility Name
CHU
City
Angers
Country
France
Facility Name
CH
City
Avignon
Country
France
Facility Name
CH
City
Beauvais
Country
France
Facility Name
CHU
City
Besançon
Country
France
Facility Name
Avicennes
City
Bobigny
Country
France
Facility Name
CHU - Ht Lévêque
City
Bordeaux
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
Country
France
Facility Name
CH
City
Béziers
Country
France
Facility Name
CHU d'Estaing
City
Clermont Ferrand
Country
France
Facility Name
Colmar Ch
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre G.F. Leclerc
City
Dijon
Country
France
Facility Name
CHU
City
Dijon
Country
France
Facility Name
Polyclinique
City
Francheville
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
Country
France
Facility Name
CHRU - Hôpital Huriez
City
Lille
Country
France
Facility Name
CHU La Timone
City
Marseille
Country
France
Facility Name
Ipc - Cac
City
Marseille
Country
France
Facility Name
CH Layne
City
Mont de Marsan
Country
France
Facility Name
Centre Cahterine de Sienne
City
Nantes
Country
France
Facility Name
Polyclinique le Languedoc
City
Narbonne
Country
France
Facility Name
CH Georges Menon
City
Niort
Country
France
Facility Name
CHR - Gasto
City
Orléans
Country
France
Facility Name
AP - HP - Pitié Salpêtrière
City
Paris
Country
France
Facility Name
CH
City
Pau
Country
France
Facility Name
CH
City
Perpignan
Country
France
Facility Name
CHU
City
Rouen
Country
France
Facility Name
CH Le Foll
City
Saint Brieuc
Country
France
Facility Name
Clinique Armoricaine
City
Saint Brieuc
Country
France
Facility Name
Polyclinique Côte Basque Sud
City
Saint Jean De Luz
Country
France
Facility Name
CH Robert Morlevat
City
Semur en Auxois
Country
France
Facility Name
CAC
City
Strasbourg
Country
France
Facility Name
Polyclinique de l'Ormeau
City
Tarbes
Country
France
Facility Name
Hôpitaux du Leman
City
Thonon Les Bains
Country
France
Facility Name
Clinique Saint Jean du Languedoc
City
Toulouse
Country
France
Facility Name
CHRU Trousseau
City
Tours
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30343254
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.
Results Reference
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First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

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