Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

NCT ID: NCT01120639

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2020-11-15

Brief Summary

The purpose of this study is to investigate the safety and effectiveness of a combination treatment for glioblastoma multiforme utilizing radiotherapy plus the FDA-approved chemotherapy drug temozolomide

Detailed Description

Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme.

Secondary Objectives:

1. Assess the short- and long-term adverse effects.

2. Determine the radiographic response rate.

3. Determine the overall survival rate.

4. Assess quality of life during treatment

To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients will be evaluated for surgical candidacy and resectability. Patients who are surgical candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis. Radiation will be delivered in five fractions.

Conditions

Glioblastoma; Cancer of Brain and Nervous System; Glioblastoma Multiforme

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

Stereotactic Radiosurgery (SRS)

Intervention Type: PROCEDURE

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

Stereotactic Radiosurgery (SRS)

Intervention Type: PROCEDURE

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

Stereotactic Radiosurgery (SRS)

Intervention Type: PROCEDURE

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) \< 60 cm³ vs 60 to 150 cm³.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

Stereotactic Radiosurgery (SRS)

Intervention Type: PROCEDURE

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Interventions

Temozolomide

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

Intervention Type: DRUG

Stereotactic Radiosurgery (SRS)

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Intervention Type: PROCEDURE

Other Intervention Names

Temodar; Temodal; Hypofractionated stereotactic radiosurgery (h-SRS); Hypofractionated stereotactic radiotherapy; Cyberknife surgery

Eligibility Criteria

Inclusion Criteria

• Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must be made by surgical biopsy or excision
• The tumor must be supratentorial in location
• The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume
• Age ≥ 18 years
• Life expectancy of at least 12 weeks
• Patient must have adequate organ function to tolerate temozolomide (details in the protocol)

Exclusion Criteria

• Patients who have previously been treated with brain irradiation to the region that would result in overlap of the radiation fields
• Tumor foci detected below the tentorium
• Multifocal disease or leptomeningeal spread
• Prior allergic reaction to the study drugs involved in this protocol
• Patients with pacemaker will be allowed to undergo CT instead of MRI
• Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Scott Soltys

Assistant Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Gerard Soltys, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SU-04202010-5726

Identifier Type: OTHER

Identifier Source: secondary_id

BRN0012

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-17774

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-17774

Identifier Type: -

Identifier Source: org_study_id