Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting
This study is for people with desmoid tumours that have started to grow or cause symptoms after a period of watchful waiting. Usually, if your tumour grows, you might be given medication, like chemotherapy. This study compares that medical treatment with a procedure called cryoablation, which uses extreme cold to destroy the tumour. Researchers want to find out which treatment is more effective for these types of growing tumours. Patients in the study might get one treatment first, and if needed, they could switch to the other. This helps make sure everyone has access to cryoablation if it's the right choice for them.
במבט חטוף
על מה המחקר הזה?
When someone is first diagnosed with a desmoid tumour, doctors often suggest a 'wait and see' approach. This means they monitor the tumour closely to see if it grows or causes problems, rather than treating it straight away. If the tumour does start to grow or causes symptoms, doctors usually recommend medicines, which can include certain types of chemotherapy.
This study, however, is looking into another treatment option called cryoablation. This procedure uses very cold temperatures to freeze and destroy the tumour. Cryoablation has already shown promise in treating larger desmoid tumours that are growing or causing symptoms. The main goal of this study is to compare cryoablation with the usual medical treatments to see which is more effective when a desmoid tumour starts to progress after the initial 'wait and see' period.
Being part of this study means you would be randomly assigned to either receive cryoablation or medical therapy. The good news is that the study design allows for a 'cross-over'. This means if the first treatment isn't working as well as hoped, or if it becomes necessary, you might be able to switch to the other treatment. This ensures that all patients potentially benefit from cryoablation if it's found to be helpful.
נקודות עיקריות
- Compares freezing tumours (cryoablation) with medicine.
- For desmoid tumours growing after 'wait and see'.
- Patients aged 13 and older can take part.
- Opportunity to receive cryoablation if it's the right choice.
- Close monitoring of your tumour's progress.
מי עשוי להיות זכאי?
This study is looking for volunteers who are at least 13 years old and have a desmoid tumour that is not inside the tummy area (extra-peritoneal). We need to have a clear diagnosis of your tumour from a recent biopsy.
Your tumour must have started to grow or cause more symptoms after a period where doctors were just watching it. It also needs to be easily reached by the special tools used for cryoablation, and the doctors must be confident they can remove 100% of it using this method, even if it takes more than one try. You should also be generally well, able to carry out your normal daily activities, and have healthy blood test results.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Are you 13 years old or older?
- Do you have a desmoid tumour not in your tummy area?
- Has your tumour grown or caused more symptoms recently?
- Is your tumour in a place where it can be frozen safely?
- Are your general health and blood tests good?
מה כרוך בהשתתפות?
The specific details of your participation, such as how many visits you'll need, what assessments will be done, and the total duration, are not fully described in this summary. However, you would be randomly assigned to either receive cryoablation or medical therapy. Cryoablation is a procedure, so it would involve appointments for the treatment itself. Medical therapy would involve taking medication, likely with regular check-ups to monitor its effects. There would be imaging scans, like MRI, to keep track of your tumour's size and to see how well the treatment is working. You will have regular checks of your health and blood tests. You'll need to use reliable contraception if you're a woman who could become pregnant. The study aims to follow your progress and the effect of the treatment over time.
סיכונים ותועלות פוטנציאליים
מיקומים (13)
- Service d'oncologie/CHU de Besançonמיקוד מאומתבזאנסון, צרפת· עדיין לא מגייסים
- Service d'Oncologie Médicale, Service de Radiologie Interventionnelle, Institut BERGONNIEמיקוד מאומתבורדו, צרפת· גיוס
- Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre François BACLESSEמיקוד מאומתקאן, צרפת· גיוס
- Service d'Oncologie Médicale -Centre Georges François LECLERCמיקוד מאומתדיז'ון, צרפת· גיוס
- Service d'Oncologie Médicale, Service de Radiologie Interventionnelle-Centre Léon BERARDמיקוד מאומתליון, צרפת· גיוס
- Service d'Oncologie Médicale, service de Radiologie Interventionnelle,CHU de Marseille, Hopital La Timoneמיקוד מאומתמרסיי, צרפת· גיוס
- Service de Radiologie-CHU de Nantesמיקוד מאומתננט, צרפת· גיוס
- Service d'Oncologie Médicale-Centre Antoine LACASSAGNEמיקוד מאומתניס, צרפת· גיוס
- Service d'Oncologie Médicaleמיקוד מאומתSaint-Herblain, France· גיוס
- Institut de cancérologie Strasbourg Europe (ICANS)מיקוד מאומתשטרסבורג, צרפת· גיוס
- Service d'Imagerie Interventionnelle, Hôpitaux Universitaires de Strasbourg , France, 67091מיקוד מאומתשטרסבורג, צרפת· גיוס
- Service d'Oncologie Médicale-Institut Claudius Régaud et Service de Radiologie Interventionnelle, CHU de Toulouseמיקוד מאומתטולוז, צרפת· עדיין לא מגייסים
שאלות נפוצות
What is a desmoid tumour?
It's a rare type of growth that is not cancer but can grow into nearby tissues and sometimes causes pain or problems.
What is 'watchful waiting'?
This means doctors will carefully monitor your tumour to see if it changes or grows before suggesting active treatment.
What is cryoablation?
It's a procedure that uses very cold temperatures to freeze and destroy the tumour.
Will I definitely get cryoablation in this study?
You might get cryoablation or medical therapy. The study design allows you to switch to cryoablation later if needed.
Can children join this study?
Yes, individuals aged 13 and older can take part if they meet the other study requirements.
כיצד לגלות עוד
Afshin GANGI, MD,PhD
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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