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

Federation Francophone de Cancerologie Digestive

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of Rectum

Treatments: Drug: FOLFORINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT01674309

FFCD 1102

Details and patient eligibility

About

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).

Full 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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

single arm study/ non randomized trial

Other group

Description:

FOLFORINOX

Treatment:

Drug: FOLFORINOX