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Oculocerebral Syndrome With Hypopigmentation

Desmoid Tumor

Antineoplastic Agents

All Drugs and Chemicals

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Reproductive Control Agents

Vinorelbine

Methotrexate

Vinblastine

One single cryoablation of the desmoid tumor at Day 0

Chemotherapy: at the investigator's discretion: either

* methotrexate 30mg/m² + vinblastine 6mg/m² (IV infusion) once/week for 6 months, then every other week from months 7 to 12, or
* vinorelbine 90mg/week (per os: 3x30mg, soft capsules) for 12 months.

Cryoablation

Either :

methotrexate 30mg/m² + vinblastine 6mg/m² (IV infusion) once/week for 6 months, then every other week from months 7 to 12, or vinorelbine 90mg/week (per os: 3x30mg, soft capsules) for 12 months.

Chemotherapy drug

Afshin GANGI, MD,PhD

Roberto Luigi CAZZATO, MD

Maud TOULMONDE, MD

Marie-Aude THENINT, MD

Alice HERVIEU, MD

Mehdi BRAHMI, MD

Florence DUFFAUD, MD, PhD

Arthur DAVID, MD

Agnès DUCOULOMBIER, MD

Agnès DUCOULOMBIER

Cécile GUILLEMET, MD

Emmanuelle BOMPAS, MD

Emmnauelle BOMPAS, MD

Jean-Emmanuel KURTZ, MD PhD

Jean-Emmanuel KURTZ

Sophie MARTIN

Afshin GANGI, MD, PhD

Julien GARNON, MD PhD

Thibaud VALENTIN, MD

Frédéric DESCHAMPS, MD

"Wait \& see" is currently the standard of care of recently diagnosed desmoid tumors (DT). In case of progression or symptomatic disease, medical therapy is nowadays widely used including chemotherapy.

Cryoablation has proven to be beneficial for the treatment of large, progressive and symptomatic DT.

This randomized phase II trial aims to compare cryoablation versus medical therapy in DT patients progressing after the "wait \& see" period. Moreover, a cross-over design has been anticipated to allow all patients to undergo cryoablation if necessary.

Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

A Phase II Multicentric, Randomized Trial Assessing Cryoablation Versus Medical Therapy in Desmoid Tumors Progressing After Watchful Waiting

Rates of non-progressive disease (sum of complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST criteria)

Progression-free survival 1 (PFS1: from the beginning of cryoablation or medical therapy to first disease progression) in cryoablation and medical therapy group

Rate of complete response at 12 months in cryoablation and medical therapy group with and without a cross-over treatment

Secondary Progression-free survival 2 (PFS 2: from the cross-over to second disease progression) in cryoablation and medical therapy group

The occurrence of complications and adverse reactions according to the classification of the NCI-CTCAE version 5.0 toxicity scale

EUROQOL EQ 5D will be used; score ranging from 1 (good quality of life) to 5 (poor quality of life)

BPI will be used; score ranging from 0 (no pain) to 10 (high pain)

Direction Générale de l'Offre des Soins (DGOS)

University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for desmoids

Every month we try and update this database with for desmoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for desmoids

Every month we try and update this database with for desmoids cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for desmoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.