Clinical trial · Interventional
RSHF in Colorectal Cancer
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
NCT01220063CI-TRIAL-00036371RS CAMPTOcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Radiation + Irinotecan
- description
- 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
- interventionNames
- Radiation: Radiation
- Drug: Irinotecan
Primary outcomes (1)
- measure
- tumor response accoording to recist criteria
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.