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A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM) - 1559

Studio Clinico

Patologia: Tumori del colon retto, Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

  • Age >18 years
  • Karnofsky index >70%
  • Histological proven adenocarcinoma of the colon or rectum with radiological (by CT- or MRI) or histological-/cytological verified liver metastases.
  • Metastases must be visible on diagnostic- and dose planning CT scans and on ultrasonography.
  • The patient should not be suitable for surgical resection due to technical or patient-related conditions. Resectability must be judged by a trained hepatobiliary surgeon and discussed in a multidisciplinary team meeting.
  • Presence of 1-3 lesions .
  • Diameter ≤ 40 mm.
  • All tumors should be feasible for treatment with each of the two modalities, SBRT and MWA
  • Adequate liver function: bilirubin <1.5 mg/dl, alb> 3.5g/dl, normal PT/PTT except if the patient uses anticoagulants, liver enzymes<3 times upper limit of normal. No ascites.
  • Renal function must be adequate for infusion of iv. contrast for CT-scan.
  • Adequate bone marrow function: Hbg³8 g/dl, platelets³100.000 and leucocytes ³2.000/ml.
  • Informed consent.
  • Extrahepatic disease stable or in response after CT
  • No previous abdominal radiation therapy (RT)

Criteri di esclusione: 

  • Uncontrolled primary tumor or extrahepatic disease
  • Previous abdominal radiation therapy (RT) or other local conservative treatment on lesion target.
  • Pregnant or breastfeeding patients.
  • Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression).
  • Previous inclusion in this study.
  • Underlying liver cirrhosis (Child-Pugh grade B or C).
  • Ascites and/or relevant intra-hepatic biliary tract dilatation.
  • Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.

Numero di pazienti previsti: 

250

Schema di trattamento: 

Patients will be randomised on an equal basis to either SBRT or MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of local response rate and acute toxicity. Longer-term outcomes will concentrate on oncological aspects of the disease with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.

Trattamento sperimentale: 

Stereotactic body radiation therapy versus Microwave Ablation

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Control of local disease [Time Frame: 18 months]
Evaluation of proportion of patients free from progression from starting radiotherapy

Obiettivi secondari dello studio: 

- Progression free-survival of treated patients [Time Frame: 18 months]
Evaluation of proportion of patients alive and free from progression

- Overall survival of treated patients [Time Frame: 18 months]
Evaluation of proportion of patients alive

- Incidence of acute and late complications [Time Frame: 18 months]
Evaluation of early and late post treatment complications

Centri partecipanti

Nord Italia

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Dr.ssa Marta Scorsetti
Telefono: 0282248524
Email: marta.scorsetti@humanitas.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02820194

Data di inserimento: 10.04.2019

Promotore

Istituto Clinico Humanitas

CRO

NA

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano (MI)

Riferimento: Dr.ssa Marta Scorsetti

Telefono: 0282248524

Email: marta.scorsetti@humanitas.it

Localita: Rozzano

 

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