Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of Rectum

Thank you

Trial Information

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

- 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

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

- 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

- Known hypersensitivity to any component of the treatment

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor control rate of the primary tumor and metastasis

Outcome 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

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Jean-Baptiste BACHET, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU de La Pitié Salpetrière - APHP


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

FFCD 1102



Start Date:

April 2012

Completion Date:

April 2016

Related Keywords:

  • Adenocarcinoma of Rectum
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Rectal Neoplasms
  • Neoplasm Metastasis