Mathematical Model-Adapted Radiation In Glioblastoma

NCT03557372 | Completed Results DMC FDA Device

• 1 other identifier: 18-105
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is studying a new schedule of radiation therapy for recurrent glioblastoma as a possible treatment for this diagnosis. This radiation schedule is based on a new model for radiation resistance in glioblastoma. The name of the radiation schedule involved in this study is: \- Re-irradiation for glioblastoma using a novel Mathematical Model-Adapted Radiation Fractionation Schedule

Conditions

Recurrent Glioblastoma

Keywords

Recurrent glioblastoma; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants to Complete Model Adapted Radiations Fractionation Scheduled

  Successful completion of radiotherapy is defined as receipt of all scheduled fractions of daily radiotherapy within 24 hours of once daily fractions and within 1 hour of three-times daily fractions.

  10 Days

Secondary Outcomes (8)

• Number of Participants With Radiation Necrosis

  6 months

• Number of Participants With Seizures

  6 months

• Overall Survival (OS)

  range of follow-up from date of registration was 1.2 - 38.6 months

• Grade 3-5 Treatment-related Toxicity Rate

  6 Months

• Median Progression-Free Survival (PFS)

  Disease evaluated on visit 4,5,6 and every 2-4 months in long-term. The range of follow-up from date of registration was 1.2 - 38.6 months and the median was 7.3 months.

Study Arms (1)

Mathematical Model-Adapted Radiation

EXPERIMENTAL

Mathematical Model-Adapted Radiation Fractionation Schedule

Radiation: Mathematical Model-Adapted Radiation Fractionation Schedule

Interventions

Mathematical Model-Adapted Radiation Fractionation Schedule RADIATION

* Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks * Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes. * Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment.

Mathematical Model-Adapted Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have recurrent glioblastoma (WHO Grade IV), as defined on brain imaging with CT or MRI, after prior receipt of definitive therapy including neurosurgical biopsy or resection and radiation therapy with or without systemic therapy.
• Participants must be deemed appropriate candidates for re-irradiation
• Histopathologic confirmation of disease as part of routine clinical care is required either at the time of initial diagnosis and/or at the time of recurrent disease. There is no requirement for central pathologic review.
• Age ≥ 18 years at the time of enrollment
• Karnofsky Performance Status (KPS) of at least 70

You may not qualify if:

• Participants who have received more than one prior course of radiotherapy to the local site of progressive disease
• Participants who have received prior radiotherapy to the local site of progressive disease within \< 3 months of the anticipated start of re-irradiation
• Participants with recurrent tumor extensively abutting or involving the optic structures or brainstem, as assessed by the treating radiation oncologist
• Participants without a definable tumor cavity on MRI or CT obtained at study enrollment
• Participants receiving concurrent cytotoxic chemotherapy (i.e. temozolomide, CCNU, vincristine, procarbazine) or concurrent immunotherapy (i.e. pembrolizumab, nivolumab); however, participants may receive sequential chemotherapy before or after radiation without limitation. Participants may receive concurrent corticosteroid and/or anti-angiogenic therapy (i.e. bevacizumab) if clinically indicated.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Dean JA, Tanguturi SK, Cagney D, Shin KY, Youssef G, Aizer A, Rahman R, Hammoudeh L, Reardon D, Lee E, Dietrich J, Tamura K, Aoyagi M, Wickersham L, Wen PY, Catalano P, Haas-Kogan D, Alexander BM, Michor F. Phase I study of a novel glioblastoma radiation therapy schedule exploiting cell-state plasticity. Neuro Oncol. 2023 Jun 2;25(6):1100-1112. doi: 10.1093/neuonc/noac253.

  PMID: 36402744 RESULT

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

Quality of life assessment using MDASI-BT was incomplete due to patient preference and incomplete adherence. As such, assessment by this endpoint was not possible.

Results Point of Contact

• Title: Dr. Shyam Tanguturi
• Organization: Dana Farber Cancer Institute

stanguturi@partners.org

617-632-0000

Study Officials

• Shyam Tanguturi, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 15, 2018
• Study Start: November 12, 2018
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: October 26, 2023
• Results First Posted: June 11, 2021

Record last verified: 2023-10

Locations

US (2)