NCT01220063

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

10.8 years

First QC Date

October 11, 2010

Last Update Submit

January 4, 2019

Conditions

Metastatic Colorectal Cancer

Keywords

RSHFIrinotecanColorectal Cancermetastases

Outcome Measures

Primary Outcomes (1)

  • tumor response accoording to recist criteria

    5 years

Study Arms (1)

Radiation + Irinotecan

OTHER

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

Radiation: RadiationDrug: Irinotecan

Interventions

RadiationRADIATION

10 Gy for 4 times (total 40 Gy)

Also known as: RSHF
Radiation + Irinotecan
IrinotecanDRUG

40 mg/m² : Day 1 and day 8

Also known as: Campto
Radiation + Irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years
  • Social Insurance
  • Performance Index \<2
  • Life expectancy\> 6 months
  • adenocarcinoma colorectal (histologically proven)
  • Metastases (inoperable or recurrent after surgery),
  • hepatic localization and / or lung (up to 3 if one organ metastasis or 3 in total if the two bodies are metastatic). The largest diameter of the metastasis will \< ou = 6cm for the liver, \< or = 6 cm for the lung. If multiple metastases, the sum of their maximum diameter is 6cm \< ou = the liver, \< ou = 6 cm for the lung.
  • Lesion (s) measurable (s) and evaluable (s)
  • CT less than 3 weeks
  • Patients must have received at least one prior chemotherapy regimen containing 5FU
  • Patients may have received one or more lines of chemotherapy including irinotecan.
  • bilirubin \<1.5 x ULN
  • AST and ALT \<5x ULN
  • neutrophils\> 1.5x109 / L, platelets\> 100x109 / L, hemoglobin\> 9 g / dL
  • TP, TCA Normal (only for patients treated with a permanent implant)
  • +1 more criteria

You may not qualify if:

  • contraindication to the administration of irinotecan.
  • History of radiotherapy in the thoraco-abdominal-cons indicating further irradiation.
  • History of other invasive cancer treated in a period of less than 5 years (basal cell carcinoma and non-invasive cervical excepted)
  • Metastatic disease diffuse or more than three metastases in the liver and / or lung during the natural history of disease (excluding any patient is having a complete radiological response on several metastases although 1-3 residual after treatment ( s) medical (at)).
  • Location (s) tumor (s) = CTV to less than 12 mm laterally or less than 15 mm in the cranio-caudal, stomach, small intestine, esophagus, trachea, bronchi of right and left pulmonary arteries and right and left.
  • Pregnancy or breastfeeding.
  • \- Lack of means or refusal to use effective contraception for men or women of childbearing age.
  • Any other concomitant experimental treatment.
  • Any other concurrent anticancer therapy, immunotherapy or hormonal therapy.
  • Monitoring impossible because of psychological, sociological or because of geographical distance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hôpital Saint André

Bordeaux, 33075, France

Location

Centre Oscar Lambret

Lille, 59 000, France

Location

Centre Léon Berard

Lyon, 69 000, France

Location

Centre hospitalier Lyon Sud

Lyon, 69000, France

Location

Hôpital la Source

Orléans, 45100, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

RadiationIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical PhenomenaCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • RIO EMMANUEL, MD

    INSTITUT DE CANCEROLOGIE DE L'OUEST

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

October 13, 2010

Study Start

October 19, 2007

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)