RSHF in Colorectal Cancer

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT01220063
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation — RADIATION
    10 Gy for 4 times (total 40 Gy)
  • Irinotecan — DRUG
    40 mg/m² : Day 1 and day 8

Study Details

The purpose of this study is to study stereotactic radiotherapy with a dose of 40 Gy in 4 fractions over 2 weeks with concomitant 40 mg/m2 of irinotecan (1st and 3rd irradiation session).

Key Dates

Start date
Oct 19, 2007
Status verified
Jan 2019
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Radiation + Irinotecan
    Irinotecan will be administered : \- 40 mg/m² in serum physiologique during 30 to 90 min at D1 and D8 of radiotherapy Radiotherapy (RSHF) will be administered : * at D1, D3, D8 and D10 * 48 Gy, 12 Gy by fractions twice a week

Primary Outcome Measure

tumor response accoording to recist criteria [ Time Frame: 5 years ]

Related Studies