Olaparib and radiotherapy In newly-diagnosed glioblastoma
- Conditions
- GliomasCancerMalignant neoplasm of brain
- Registration Number
- ISRCTN52658296
- Lead Sponsor
- HS Greater Glasgow and Clyde (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 140
1. Age 18 - 69: WHO performance status 2 at initial oncology consultation or performance status 0-1 but otherwise unsuitable for radical radiotherapy with concomitant and adjuvant temozolomide.
2. Age over 70: WHO performance status 0 or 1 at initial oncology consultation
3. Histologically confirmed diagnosis of glioblastoma
4. Life expectancy greater than 12 weeks
5. No previous radiotherapy or chemotherapy for primary or secondary CNS malignancy
6. Adequate haematological, hepatic and renal function defined as below:
Haemoglobin >/= 9.0 g/dL, absolute neutrophil count >/= 1.5 x 109/L, platelet count >/= 100 x 109/L, bilirubin 50 ml/min. If the creatinine clearance / glomerular filtration rate is less than 50 ml/min as calculated by the Cockroft-Gault/Wright formula, then the creatinine clearance / glomerular filtration rate should be measured by either a radio-isotope technique or by 24-hour urine collection.
7. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed
8. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
9. Ability to swallow oral tablets/capsules
1. WHO performance status >2
2. Life expectancy less than 12 weeks
3. Active concurrent malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If history of prior malignancy, must be disease-free for >5 years.
4. Prior treatment for primary or secondary CNS malignancy
5. Confusion or altered mental state that would prohibit understanding and giving of informed consent
6. Concomitant treatment with medicines detailed in section 5.10 of protocol.
7. Female patients who are able to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom, have an intra-uterine device and condom, diaphragm with spermicidal gel and condom) effective at the first administration of either IMP, throughout the trial, and for six months afterwards, are considered eligible.
8. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] effective at the first administration of IMP, throughout the trial, and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
9. Administration of any investigational drug within 28 days of receiving the first dose of trial treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: The recommended dose of olaparib when administered in combination with radiotherapy<br>Phase II: Overall survival
- Secondary Outcome Measures
Name Time Method Phase I: The DLT (Dose-Limiting Toxicity) and the safety and tolerability of olaparib administered in combination with radiotherapy. <br>Phase II: <br>1. Progression-free survival measured by MRI scans during follow-up and will be assessed in accordance with the RANO guidelines<br>2. Toxicity measured using the CTCAE v.4.0 criteria and recorded at each follow-up visit<br>3. Quality of life which will be measured by the completion of QLQ30, BN20 and EQ-5D questionnaires completed by the participant at baseline and each follow-up visit