Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy followed by sequential TMZ in Advanced NSCLC Patients with CNS Metastasis versus Radiotherapy alone

Phase 1

• Conditions: Patients with non small cell lung cancer (NSCLC) have a high risk of developing brain metastasis, up to 40% as evaluated in autopsy studies. These patients are often heavily symptomatic and their life expectancy remains limited (median 5.4 months), using corticosteroids and radiotherapy or radiosurgery alone.

• Registration Number: EUCTR2004-001749-13-AT
• Lead Sponsor: AESCA Pharma GesmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-17
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

·Prior histologic confirmation of NSCLC
·Optional: NSCLC histologic confirmation of metastasis of NSCLC
·Presence of bidimensionally measurable disease in the brain
·No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
·Age: > 18 years
·No evidence of progression at extracranial sites
·Karnofsky Performance status ³ 60 %
·ANC > 1.500/mm3 , platelets > 100.000/mm3, hemoglobin > 8g/dl
·Serum creatinine and bilirubine < 1.5 times upper normal limit of testing laboratory
·SGOT; SGPT < 3 times upper limit of testing laboratory
·Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
·Prior neurosurgery > 2 weeks from initiating treatment with TMZ
·Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with TMZ
·Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception
·Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Chemotherapy or biologic therapy within four weeks prior initiating therapy with TMZ
·Prior radiation therapy for brain < 4 weeks from initiating therapy with TMZ
·Surgery within two weeks prior to TMZ administration
·Known HIV disease
·Acute infection requiring intravenous antibiotics
·Rapid disease progression outside of brain at study entrance.
·Any reason making compliance to the protocol improbable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified