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Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA) (PARADIGMA)

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ClinicalTrials.gov Identifier: NCT03480867
Recruitment Status : Withdrawn (competing study was opened by the surgeon after this trial was opened)
First Posted : March 29, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Valerie Panet-Raymond, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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Brief Summary:

Glioblastoma (GBM) is the most common primary brain cancer in adults. Despite surgery, conventional radiotherapy, and chemotherapy, the average survival for GBM is 15-16 months. Although additional chemoradiotherapy has been shown to increase survival, the majority recur at the original location.

Despite many efforts to improve the local control by improving surgical techniques, increasing the radiotherapy dose or adding newer chemotherapy agents, these attempts have failed to show a survival benefit or an improved cancer control. People who are not participating in a study are usually treated with surgery followed by radiation (6 weeks duration) together with temozolomide (chemotherapy drug) followed by temozolomide alone. For patients who receive this usual treatment approach for this cancer, about 4 out of 100 are free of cancer growth five years later. Because GBM invades the surrounding normal brain, this study is looking into the possibility of minimizing invasion by starting treatment using the combination of radiotherapy and chemotherapy prior to surgery. This approach is an experimental form of treatment and the diagnosis is based exclusively on imaging and not on histology of the tumour tissue, and there is a possibility that your tumor may not be a GB but of other origins.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme, Adult Drug: Temozolomide Radiation: Pre-Operative Radiation Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: RT 28Gy in 7 fractions with a concomitant boost of 42Gy in 7 fractions+ Temozolomide (75mg/m2) followed by surgery then Temozolomide (150-200mg/m2) q 5 days every 28 days.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-operative Radiation Therapy (RT) and Temozolomide (TMZ) in Patients With Newly Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pre-operative RT and TMZ
  • Single Arm: Pre-operative Radiation +Temozolomide followed by Surgery plus six cycles of Temozolomide
 Drug: Temozolomide
Experimental: Registered one arm study Seven days of pre-operative Radiation+Temozolomide followed by surgery plus TMZ, as adjuvant component.for six cycles.
Other Name: Surgery

Radiation: Pre-Operative Radiation
Radiation is given with Temozolomide for 7 days before surgery


Outcome Measures
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Primary Outcome Measures :
  1. To assess toxicity of the regimen [ Time Frame: one year ]
    Toxicity will be assessed and graded using CTCAE V. 4.03


Secondary Outcome Measures :
  1. Number of patients completing the study treatment [ Time Frame: one year. ]
    To determine the overall survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Newly diagnosed (MR image-based) GBM - Must be able to undergo gadolinium-enhanced MRI.
  • Must be a candidate for radical surgical resection in the opinion of the neurosurgeon.
  • The tumor must measure less than 6 cm in maximum diameter. The tumor diameter will be the greatest diameter as measured on the contrast-enhanced MRI.
  • A neurosurgical oncologist, radiation oncologist and neuro-oncologist will assess each patient in advance of enrollment.
  • The estimated post-surgical radiation field must be compatible with the proposed radiation scheme - ie, to ensure a safe radiation margin from structures such as the optic apparatus and brain stem.
  • The GBM tumor must be located in the supratentorial compartment only (any component involving the brain stem or cerebellum is not allowed)
  • Age>18years
  • Karnofsky Performance Status (KPS) 70.
  • History and physical examination within 14 days from start of therapy, including documentation of steroid dose.
  • Adequate complete blood counts (Absolute neutrophil count (ANC) .:! 1,800. cells/mm3; Platelets.:! 100,000 cells/mm3; Hemoglobin.:! 10.0 g/dl), renal and liver function within 14 days prior to therapy with values< 3x (upper limit normal) ULN.
  • For females of child-bearing potential, negative serum pregnancy test within 14 days prior to therapy and use of contraception.
  • Signed consent form.

Exclusion Criteria:

  • Tumors within 1 cm from critical structures (brainstem, optic apparatus), or with massive edema, or with the possibility of herniation, or any tumor that in the neurosurgeon's opinion would be considered unsafe to delay surgery or is not grossly resectable.
  • Prior invasive malignancy (except for non-melanomatous skin cancer, non- invasive bladder cancer, and non-invasive cervix cancer) unless disease free for 2:5 years.
  • Recurrent or multifocal GBM.
  • Any site of metastatic disease (drop metastases).
  • Prior chemotherapy or radiation therapy to the head or neck (except for T1 glottic tumor
  • Severe active co-morbid medical condition as assessed by medical team.
  • Patients enrolled in any other protocol.
  • Inability to undergo MRI.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03480867


Locations
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Canada, Québec, Canada
McGill University Health Centre-Cedars Cancer Centre
Montréal, Québec, Canada, Canada, H4A 3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Valerie Panet-Raymond, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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Publications:

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Responsible Party: Valerie Panet-Raymond, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03480867     History of Changes
Other Study ID Numbers: MUHC-2016-1524
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon official request approved by the Research Ethics Board (REB), some data may be shared depending on what needs to be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents