Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue for Primary Central Nervous System Lymphoma in Young Patients (PRECIS)
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ClinicalTrials.gov Identifier: NCT00863460 |
Recruitment Status :
Active, not recruiting
First Posted : March 18, 2009
Last Update Posted : February 5, 2019
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Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
Condition or disease | Intervention/treatment | Phase |
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Primary Central Nervous System Lymphoma | Radiation: cranial radiotherapy Drug: intensive chemotherapy and hematopoietic stem cell rescue Drug: MTX based chemotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y) |
Actual Study Start Date : | October 3, 2008 |
Actual Primary Completion Date : | May 17, 2016 |
Estimated Study Completion Date : | May 2026 |
Arm | Intervention/treatment |
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Active Comparator: A
MTX-based chemotherapy followed by WBRT
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Radiation: cranial radiotherapy
40 Gy Drug: MTX based chemotherapy R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
Other Names:
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Experimental: B
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
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Drug: intensive chemotherapy and hematopoietic stem cell rescue
intensive chemotherapy and hematopoietic stem cell rescue
Other Names:
Drug: MTX based chemotherapy R-MBVP 2 cycles day1 and day28 followed by R-Aracytine 2 cycles days58&59 and days79&80
Other Names:
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- 2-years progression-free survival in each arm [ Time Frame: 2 years after inclusion ]
- Overall response rate at the end of the procedure [ Time Frame: at the end of procedure at 1 and 2 years ]
- Overall survival [ Time Frame: 2 years after inclusion ]
- Event-free survival [ Time Frame: 2 years after inclusion ]
- Neurotoxicity [ Time Frame: each years during ten years ]
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
- All histological types of non-Hodgkin's lymphoma, except MALT
- Age > 18 and < 60 ans.
- Negative for HIV, HCV and HBV
- Written informed consent -
Exclusion Criteria:
- Age < 18 or > 60 ans
- Isolated intra-ocular lymphoma
- Previous history of indolent lymphoma
- Previous chemotherapy or radiotherapy for PCNSL
- Isolated CNS relapse of systemic NHL
- Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
- Renal insufficiency or creatinin clearance < 60 ml/min
- Liver enzymes > 3N.
- Platelets < 100 000/mm3 or neutrophils < 1500/mm3)
- Previous history of organ transplantation or other cause of severe immunodeficiency
- Pregnancy or active sexual women with no contraception
- Unable to follow the protocol for any reason
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): NCT00863460
Principal Investigator: | Carole Soussain, MD | Institut Curie - Hôpital René Huguenin |
Responsible Party: | Institut Curie |
ClinicalTrials.gov Identifier: | NCT00863460 |
Other Study ID Numbers: |
CRH 07/422/H EudraCT N° 2007-005378-30 |
First Posted: | March 18, 2009 Key Record Dates |
Last Update Posted: | February 5, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Prednisone Cyclophosphamide Busulfan Thiotepa Carmustine Methotrexate Etoposide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Abortifacient Agents, Nonsteroidal |