Multicenter, phase II trial of Tumor Treatment Fields system in patients with newly diagnosed IDH-wildtype lower-grade gliom

Phase 2

Recruiting

• Conditions: IDH wild-type glioma (grade III) (anaplastic astrocytoma); Glioma

• Registration Number: JPRN-jRCT2032230060
• Lead Sponsor: Tanaka Shota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

At the time of enrollment, patients will be included if they meet all of the following criteria.
1) Diagnosis of IDH wild-type glioma (grade III) (anaplastic astrocytoma) *after tumor resection or biopsy.
*According to the WHO Classification of Brain Tumors, Fourth Revision (2016)
2) No history of surgical treatment for glioma (first case), except for resection or biopsy. However, if a second surgery (excision) is performed on the residual lesion within 28 days of the first surgery (excision or biopsy), the patient is eligible.
3) Implantation of carmustine intracerebroventricularly at the time of surgery is acceptable.
4) Preoperative contrast-enhanced MRI of the head shows tumor only supratentorial (not in the brainstem or cerebellum).
5) No evidence of disseminated lesions on contrast-enhanced MRI of the head prior to enrollment.
6) Can be registered regardless of the presence or absence of measurable lesions prior to enrollment.
7) Radiation therapy with temozolomide (TMZ) is the initial treatment.
Radiotherapy is administered for more than 50 Gy in the initial treatment and TMZ in combination with radiotherapy is administered for more than 30 days.
8) Within 49 days of the last day of radiation therapy with TMZ
9) Age 18 years or older on the date consent is obtained.
10)Karnofsky performance status (KPS) more than equal 70
11) No prior chemotherapy or radiation therapy for other types of cancer. However, prior endocrine therapy (hormone therapy for breast cancer, hormone therapy for prostate cancer) is eligible.
12) All of the following conditions are met. All laboratory tests should be the most recent within 14 days before registration.
(1) Neutrophil Counts>=1,500 /mm3
(2) Hemoglobin>=8.0 g/dL
(3) Platelet Counts>=10 *10,000/mm3
(4)AST(GOT)<=120 U/L
(5)ALT(GPT)<=120 U/L
(6)Creatinine<=1.5 mg/dL
13) Expected to survive at least 12 weeks from the date of registration
14) Can use effective contraceptive methods (if of childbearing age)
15) The patient's free written consent to participate in this clinical trial has been obtained after receiving a full explanation of the study (no surrogate consent is acceptable).

Exclusion Criteria

Any of the following conditions shall not apply
1) Have active overlapping cancers(Simultaneous overlapping/multiple cancers and iatrogenic overlapping/multiple cancers with a disease-free interval of 5 years or less. However, carcinoma in situ (intraepithelial carcinoma) and intramucosal carcinoma equivalent lesions that are considered curable by local treatment are not included in active multiple/multiple cancers.)
2) Has an infection requiring systemic treatment
3) Complicated infectious meningitis requiring treatment
4) Fever greater than 38 degree Celsius at axillary temperature at the time of registration
5) Delayed wound healing after excision or biopsy
6) Patients with implanted medical devices that are contraindicated, such as pacemakers, defibrillators, or deep brain stimulators
7) Pregnant, possibly pregnant, or breastfeeding women
8) Psychosis or psychiatric comorbidities that would make participation in the study difficult
9) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive agents for diseases other than brain tumors. Steroids for brain tumors are acceptable
10) Complicated unstable angina (angina with onset or worsening of attacks within 3 weeks prior to enrollment), or history of myocardial infarction within 6 months
11) Pulmonary fibrosis, interstitial pneumonia, or severe emphysema as diagnosed by chest x-ray, or with one or more of the following
12) Gadolinium is not available due to drug allergy
13) HIV antibody is positive
14) HBs antigen is positive
15) Participating in another clinical trial
16) Other conditions that the investigator or subinvestigator considers inappropriate for participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified