Interest of a Dose Decrease for Radiotherapy Associated With Chemotherapy for Treatment of Standard Risk Adult Medulloblastomas (RSMA2010)
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| ClinicalTrials.gov Identifier: NCT01857453 |
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Recruitment Status : Unknown
Verified July 2018 by Central Hospital, Nancy, France.
Recruitment status was: Recruiting
First Posted : May 20, 2013
Last Update Posted : July 5, 2018
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Adult medulloblastoma is a rare tumour.
The "standard risk " group (complete surgery or residual tumour lower than 1,5 cm2, absence of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC amplification and exclusion of large cells medulloblastoma) concerns, for the adult population, a majority of patients at diagnosis (about ¾ of cases).
Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy on the posterior fossa and 36 Gy on the nevraxis).
This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and general) wich decreases gradually when patient goes away from the treatment period.
For this category of patients and this modality of treatment, The French intergroup experience, pleads in favour of a late and progressive neurotoxicity.
This neurotoxicity is associated with a clear degradation of the quality of life.
In the light of paediatric studies :
We propose a phase II study to estimate the interest of a decrease of radiation doses compensated by a chemotherapy according to the following schedule
- carboplatine + etoposide based chemotherapy every 28 days x 2
- followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed.
The majority of French centres concerned with the neuro-oncology are involved in this trial.
About 25 new cases by year are waited. A centralized analysis of pathological slides and of the pre and post surgery Magnetic Resonance Imaging is foreseen.
The main objective is to estimate the survival without disease at 1 year
Secondary objectives associate the evaluations of the rate of complete response at the end of procedure, the overall survival, the survival without disease, the survival without events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until definitive deterioration of the quality of life Associated studies
Two associated studies are besides foreseen (parallel search for co-financing):
- A biologic study is planed with the aim to confirm, by morphological, genomic and transcriptomic studies, the interest, for the adult population, of the prognostic markers used in paediatric population
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A radiological study is planed with the aim to estimate the interest :
- of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature detection of recurrences
- of the study of functional connectivity in correlation with the neuropsychological follow-up for the analysis of the aetiology and premature markers of neurotoxicity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Medulloblastoma | Drug: carboplatine Drug: Etoposide Radiation: radiation therapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 97 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | National, Multicentric, Prospective Phase II Study Estimating the Interest of a Dose Decrease for Radiation Therapy Associated With a Carboplatine and Etoposide Based Chemotherapy for the Treatment of Standard Risk Adult Medulloblastomas |
| Actual Study Start Date : | April 10, 2013 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: teatment arm
carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed
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Drug: carboplatine
carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed Drug: Etoposide carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed Radiation: radiation therapy carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed |
- survival without disease at 1 year [ Time Frame: one year ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologic diagnosis of medulloblastoma expect large cells type
- Patients between 18 and 70 years
- Résidual tumor les than 1.5 square centimeter (greater diameter)
- No sus tentorial or spinal location
- Absence of tumoral cells in the cerebrospinal fluid taken before, during or 14 days after surgery
- Absence of MYC amplification
- AID, B and C hepatitis positive serologies
- Negative βHCG dosage and effective contraception for potentially pregnant women
- Writed consent obtain
Exclusion Criteria:
- Age < 18 or > 70 years
- Previous diagnosis of medulloblastoma
- Previous treatment with chemotherapy
- Previous cranial or spinal radiation therapy
- Carboplatinum or etoposide contraindication
- Previous cancer in the five years before the inclusion except basocellular carcinoma of the skin and in situ cancer of the uterine cervix
- Severe renal renal insufficiency with a creatinine clearance < 60 ml/min
- Liver insufficiency with a contraindication of carboplatinum or etoposide based chemotherapy or elevated transaminases > 3N.
- Insufficient haematopoetic reserve (thrombocytes < 100 000/mm3 ou neutrophil polynuclear < 1500/mm3)
- Previous organ transplantation or immunosuppression
- Pregnant women or women without contraception
- Incapacity of respecting the recommanded follow up
- Participation in another therapeutic clinical trial
- Patient under custody
- Not social security regime membership
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857453
| Contact: Luc TAILLANDIER | +33 3 83 85 16 88 | l.taillandier@chu-nancy.fr | |
| Contact: Charlotte CARNIN | +33 3 83 85 95 92 | c.carnin@chu-nancy.fr |
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| Principal Investigator: | Luc TAILLANDIER | CHU NANCY - France |
| Responsible Party: | Central Hospital, Nancy, France |
| ClinicalTrials.gov Identifier: | NCT01857453 |
| Other Study ID Numbers: |
2012-002803-16 |
| First Posted: | May 20, 2013 Key Record Dates |
| Last Update Posted: | July 5, 2018 |
| Last Verified: | July 2018 |
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Adult Patients Medulloblatoma Standard risk group Chemotherapy Radiotherapy Quality of Life |
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Medulloblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Etoposide Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |