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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 :
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | 10 Gy for 4 times (total 40 Gy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor response accoording to recist criteria | 5 years |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| RIO EMMANUEL, MD | INSTITUT DE CANCEROLOGIE DE L'OUEST | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint André | Bordeaux | 33075 | France | |||
| Centre Oscar Lambret |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2026 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Irinotecan | Drug | 40 mg/m² : Day 1 and day 8 |
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|
| Lille |
| 59 000 |
| France |
| Centre Léon Berard | Lyon | 69 000 | France |
| Centre hospitalier Lyon Sud | Lyon | 69000 | France |
| Hôpital la Source | Orléans | 45100 | France |
| Centre René Gauducheau | Saint-Herblain | 44805 | France |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |