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Adenocarcinoma of RectumPhase 2NCT01674309

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

A Phase 2 study testing FOLFORINOX in people with Adenocarcinoma of Rectum, run by Federation Francophone de Cancerologie Digestive at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma of Rectum
What is being tested?
FOLFORINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
37 sitesFrance
Study dates
Apr 2012to Oct 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CHU

    Amiens

  • CHU

    Angers

  • CH

    Avignon

  • CH

    Beauvais

  • CHU

    Besançon

  • CH

    Béziers

  • Avicennes

    Bobigny

  • CHU - Ht Lévêque

    Bordeaux

  • Institut Bergonie

    Bordeaux

  • CHU d'Estaing

    Clermont-Ferrand

  • Colmar Ch

    Colmar, 68024

  • Centre G.F. Leclerc

    Dijon

  • CHU

    Dijon

  • Polyclinique

    Francheville

  • CHD Vendée

    La Roche-sur-Yon

  • Clinique Victor Hugo

    Le Mans

  • CHRU - Hôpital Huriez

    Lille

  • CHU La Timone

    Marseille

  • Ipc - Cac

    Marseille

  • CH Layne

    Mont-de-Marsan

  • Centre Cahterine de Sienne

    Nantes

  • Polyclinique le Languedoc

    Narbonne

  • CH Georges Menon

    Niort

  • CHR - Gasto

    Orléans

  • AP - HP - Pitié Salpêtrière

    Paris

  • CH

    Pau

  • CH

    Perpignan

  • CHU

    Rouen

  • CH Le Foll

    Saint-Brieuc

  • Clinique Armoricaine

    Saint-Brieuc

  • Polyclinique Côte Basque Sud

    Saint-Jean-de-Luz

  • CH Robert Morlevat

    Semur-en-Auxois

  • CAC

    Strasbourg

  • Polyclinique de l'Ormeau

    Tarbes

  • Hôpitaux du Leman

    Thonon-les-Bains

  • Clinique Saint Jean du Languedoc

    Toulouse

  • CHRU Trousseau

    Tours

Other trials in France

About this study

Official title: 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).
Read the 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).
  1. Inclusion and non inclusion criteria
  2. Treatment
  3. Follow up
Being tested
FOLFORINOX
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOLFORINOXDrug

    INTRAVENOUS administration

Study groups in NCT01674309
Study groupRoleWhat they receive
single arm study/ non randomized trialOtherFOLFORINOX
Receives: Drug: FOLFORINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 months

Secondary outcomes (5)

  1. Toxicity of the treatment

    Number of patients presenting the main toxicities during the study

    Measured: Up to 4 months after Last Patient First Visit

  2. 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

    Measured: 4 months

  3. 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

    Measured: Up to 4 months after Last Patient First Visit

  4. 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

    Measured: 4 months

  5. metastasis response rate

    The metastasis tumor response rate is the Complete response or the Partial response of metastasis using RECIST 1.1 criteria

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJan 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674309
Sponsor's protocol ID
FFCD 1102
Status last verified
Feb 2018
First submitted
2 Apr 2012
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 30343254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFORINOX in people with Adenocarcinoma of Rectum, run by Federation Francophone de Cancerologie Digestive at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor control rate of the primary tumor and metastasis (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01674309, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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