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Completed

NCT Number: NCT01220063

RSHF in Colorectal Cancer

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Saint André, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Informed consent signed.

Exclusion criteria

  • 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.

Treatment and study plan

Radiation

Radiation

10 Gy for 4 times (total 40 Gy)

Other names: RSHF

Irinotecan

Drug

40 mg/m² : Day 1 and day 8

Other names: Campto

Primary outcomes

  1. tumor response accoording to recist criteria

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

CLINICAL MULTICENTER STUDY OF PHASE II AND RADIOBIOLOGY ASSESSING Hypofractionated Stereotactic Radiotherapy With Irinotecan (Campto) IN THE TREATMENT OF LIVER METASTASIS AND / OR PULMONARY, Unoperated or Recurrent After Surgery of a Colorectal Cancer

Acronym: RS CAMPTO

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2010
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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