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Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

Primary Purpose

Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intensity-Modulated Radiation Therapy

Quality-of-Life

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have histologically confirmed low or high grade glioma (grade II-IV)
Karnofsky performance status (KPS) >= 60
Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment
Estimated survival >= 3 months
Labs considered acceptable per standard of care
Patient must sign a study specific informed consent form
Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery

Exclusion Criteria:

Prior history of scalp radiation or intolerance to standard course of radiation treatment
Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use)
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Karnofsky performance status (KPS) < 60
Patient can't have magnetic resonance imaging (MRI) scan
Active collagen vascular disease

Sites / Locations

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (IM-SRT)

Arm Description

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Outcomes

Primary Outcome Measures

Incidence of wound infection or wound dehiscence

Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.

Secondary Outcome Measures

Incidence of titanium implants

Will the impact of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. Rates of titanium implant discomfort will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Incidence of hair loss

Will assess the impact of IM-SRT on the incidence of hair loss. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Incidence of recovery rate

Will assess the impact of IM-SRT on the incidence of recovery rate. Will be summarized by cohort with exact 95% confidence intervals. Within-cohort changes will be estimated using linear contrasts of model parameters.

Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire

Will assess the impact on quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire. Will be modeled using mixed effects linear regression. Within-cohort changes will be estimated using linear contrasts of model parameters.

Full Information

NCT ID

NCT03251027

First Posted

August 14, 2017

Last Updated

September 29, 2023

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

1. Study Identification

Unique Protocol Identification Number

NCT03251027

Brief Title

Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

Official Title

Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 17, 2017 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial studies how well intensity-modulated stereotactic radiation therapy works in treating patients with grade II-IV glioma. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the effect of intensity-modulated (IM)-stereotactic radiotherapy (SRT) on the incidence of wound infection (requiring oral/intravenous [IV] antibiotics or surgery), or wound dehiscence. SECONDARY OBJECTIVES: I. To determine the effect of IM-SRT on the incidence of titanium implants as palpable cranial defects due to scalp thinning. II. To determine the effect of IM-SRT on the incidence of hair loss and recovery rate. III. To determine the effect on quality of life (QoL) using European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L). TERTIARY OBJECTIVES: I. To determine if treatment of Intensity-modulated stereotactic radiotherapy (IM-SRT) in patients with newly diagnosed grade II-IV gliomas can decrease the loss of scalp thickness in the coronal plane in T-1W magnetic resonance (MR) images.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma, WHO Grade II Glioma, WHO Grade III Glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (IM-SRT)

Arm Type

Experimental

Arm Description

Patients undergo intensity-modulated (IM)-stereotactic radiotherapy (SRT) daily over 6 weeks.

Intervention Type

Radiation

Intervention Name(s)

Intensity-Modulated Radiation Therapy

Intervention Description

Undergo IM-SRT

Intervention Type

Other

Intervention Name(s)

Quality-of-Life

Other Intervention Name(s)

Quality of Life Assessment, Quality-of-Life Assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Incidence of wound infection or wound dehiscence

Description

Will assess the impact of intensity-modulated stereotactic radiotherapy (IM-SRT) on the incidence of wound infection, or wound dehiscence.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Incidence of titanium implants

Description

Time Frame

Up to 2 years

Title

Incidence of hair loss

Description

Time Frame

Up to 2 years

Title

Incidence of recovery rate

Description

Time Frame

Up to 2 years

Title

Quality of life using European Quality of Life Five Dimension Five Level Scale Questionnaire

Description

Time Frame

Up to 2 years

Other Pre-specified Outcome Measures:

Title

Scalp thickness

Description

Will assess the IM-SRT on scalp thickness as determined by magnetic resonance imaging evaluations of scalp thickness in the coronal plane before conformal radiation therapy (XRT), at 9 months, and 18 months after XRT in the study group compared to time-matched historical controls of patients. Mixed effects linear regression will be used to jointly model scalp thickness measurements at pre-treatment, 9 months, and 18 months. Potential confounding factors (chemotherapy, smoking history, diabetes) will also be included in the model. The residual variance covariance matrix will be assumed to have a compound-symmetric structure to account for the correlation among repeated measurements. Linear contrasts will be used to compare the change from pre-treatment to 9 months between IM-SRT and conformal therapy patients and to compare the change from pre treatment to 18 months between IM-SRT and conformal therapy patients.

Time Frame

Up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have histologically confirmed low or high grade glioma (grade II-IV) Karnofsky performance status (KPS) >= 60 Patients must have recovered from the effects of surgery; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment Estimated survival >= 3 months Labs considered acceptable per standard of care Patient must sign a study specific informed consent form Radiation treatment must begin >= 3 weeks and =< 8 weeks after surgery Exclusion Criteria: Prior history of scalp radiation or intolerance to standard course of radiation treatment Co-morbidities that would influence wound healing including diabetes (insulin dependent) or smoking (current ongoing use) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Karnofsky performance status (KPS) < 60 Patient can't have magnetic resonance imaging (MRI) scan Active collagen vascular disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenyin Shi, MD

Phone

(215) 955-6702

wenyin.shi@jefferson.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenyin Shi, MD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Cancer Center at Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Andrews, MD

Phone

215-955-7000

12. IPD Sharing Statement

Links:

URL

https://www.jeffersonhealth.org/clinical-specialties/cancer

Description

Sidney Kimmel Cancer Center

URL

http://hospitals.jefferson.edu/

Description

Thomas Jefferson University Hospital

Learn more about this trial

Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma

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