Efficacy Study of Radiotherapy Alone Versus CCRT With Temozolomide in Grade III Gliomas Without 1p/19q Codeletion

NCT01534845 | Unknown Phase 2 DMC

• 1 other identifier: KNOG-1101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The management of anaplastic gliomas of WHO grade 3 is currently largely based on surgery followed by radiotherapy, of which prognosis remains still dismal with the median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is unclear of modest at best with conventional cytotoxic agents, and the role of temozolomide for these entities still is not elucidated.
2. 2.Codeletion of chromosome 1p/19q is considered the most important marker of prognostic significance in WHO grade 3 gliomas.
3. 3.To project a randomized phase 2 screening trial examining the efficacy of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3 gliomas without codeletion of chromosome 1p/19q.
4. 4.The prognostic significance of methylation status of MGMT and IDH1 mutation as molecular markers will be also assessed in each arm as key secondary analysis.

Conditions

Anaplastic Glioma of Brain; Loss of Chromosomes 1p/19q

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival(PFS)

  Final primary end-point: 2 year PFS. Progression free survival(PFS) is defined as the time from randomization to progressive disease or death, which ever occurs earlier.

  Assessed and followed for the duration of hospital stay, an expected average of 3 months

Secondary Outcomes (5)

• 5-year overall survival (OS)

  assessed at 10 wks, 22 wks, 34 wks, and followed up every 4 months until documentation of death.

• 5-year progression-free survival (PFS)

  assessed at 10 wks, 22 wks, 34 wks, and followed up every 4 months until documentation of disease progression or death.

• Safety (adverse events)

  up to 5 years

• Methylation status of MGMT

  baseline

• IDH mutation

  baseline

Study Arms (2)

only Radiotherapy

NO INTERVENTION

fractionated focal irradiation in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy

CCRT with Temozolomide

ACTIVE COMPARATOR

RT with daily temozolomide (75 mg/m2/day, 7 days/week) from the first to the last day of radiotherapy) and adjuvant TMZ chemotherapy (150-200 mg/m2 po qd for 5 days q 28 days for 6 cycles).

Drug: Temozolomide (Temodal)

Interventions

Temozolomide (Temodal) DRUG

RT with daily temozolomide (75 mg/m2/day, 7 days/week) from the first to the last day of radiotherapy) and adjuvant TMZ chemotherapy (150-200 mg/m2 po qd for 5 days q 28 days for 6 cycles)

Also known as: Temodal

CCRT with Temozolomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed histologically proven supratentorial anaplastic gliomas.The histological diagnosis must be obtained from a neurosurgical resection or biopsy of a tumor including an open biopsy or stereotactic biopsy.
• Absence of chromosome 1p/19q co-deletion
• Age 18 years
• Eastern Cooperative Oncology Group performance status of 0-1
• Stable or decreasing dose of steroids for 5 days prior to randomization
• Meets 1 of the following RPA classifications:class III-V
• Adequate hematologic, renal, and hepatic function
• Written informed consent

You may not qualify if:

• Prior chemotherapy within last 5 years
• Prior radiotherapy of the head and neck area
• Receiving concurrent investigational agents or has received an investigational agent within 30 days prior to randomization
• Planned surgery for other diseases (e.g. dental extraction)
• History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study
• Pregnant or lactating women
• Subject who disagree to follow acceptable methods of contraception
• Concurrent illness including unstable heart disease despite appropriate treatment, history of myocardial infarction within 6 months, serious neurological or psychological disease, and uncontrolled infection
• Subject unable to undergo Gd-MRI

Sponsors & Collaborators

• Jong Hoon Kim: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeong Hoon Kim, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Jae Young Kim, professor

  SNUH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Neurological Surgery

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 17, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2017
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

KR (1)