A randomised phase III Trial on concurrent and adjuvant Temozolomide chemotherapy in non 1p/19q deleted anaplastic glioma to evaluate overall survival.
Phase III Trial on concurrent and adjuvant Temozolomide chemotherapy in non 1p/19q deleted anaplastic glioma to evaluate overall survival.
University of Sydney
748 participants
Aug 31, 2010
Interventional
Conditions
Summary
This study looks at the effectiveness of different combinations of treatment with oral Temozolomide chemotherapy and radiotherapy, in people with brain cancer of the type non 1p/19q deleted anaplastic glioma. Who is it for? You can join this study if you have brain cancer that has been newly diagnosed (anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma) and you are not missing chromosomes 1p/19q. Trial details Participants will be randomly divided into four groups which will receive treatment as follows: 1. radiotherapy only 2. radiotherapy and Temozolomide chemotherapy at the same time 3. radiotherapy and Temozolomide chemotherapy four weeks later 4. radiotherapy and Temozolomide chemotherapy at the same time and then Temozolamide chemotherapy again four weeks later. The study aims to assess whether 1. radiotherapy and Temozolomide chemotherapy at the same time improves overall survival rates when compared with radiotherapy alone 2. Temozolamide chemotherapy given after radiotherapy improves overall survival when compared to no Temozolamide after radiotherapy. Currently different institutions adopt different strategies of radiation and chemotherapy for treating anaplastic glioma, as the most effective treatment is not known. However some studies suggest that there is an increase in progression free survival when chemotherapy is given after radiotherapy. Many glioma patients deteriorate at the time of progression. Thus prolonging the time to progression may help to keep patients in good clinical condition for longer and improve their quality of life.
Eligibility
Plain Language Summary
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Interventions
There will be 4 arms with the following interventions for treatments: Arm 1- Radiotherapy only Arm 2 - Radiotherapy and concomitant Temozolomide chemotherapy Arm 3 - Radiotherapy and adjuvant Temozolomide chemotherapy Arm 4 - Radiotherapy, concomitant Temozolomide chemotherapy and adjuvant Temozolomide chemotherapy. Radiotherapy consists of a fractionated regimen delivering a total dose of 59.4 Gy in 6.5 weeks, in a once daily schedule of 1.8 Gy per fraction for a total of 33 fractions. Concomitant Temozolomide - Patients randomised to this arm receive Temozolomide continuously orally at a daily dose of 75 mg/m2 1 hour before radiotherapy during weekdays. During weekends without radiotherapy, the drug will be taken in the morning. The dose administered will be determined by Body Surface Area (BSA), calculated at the beginning of the concomitant treatment. The daily dose throughout the trial will be rounded to the nearset 10 mg. Adjuvant Temozolomide - Patients randomised to this arm will start adjuvant Temozolomide after a 4 week resting period after the end of radiotherapy. Temozolomide will then be administered orally once a day for 5 consecutive days (days 1-5). The starting dose of the first cycle will be 150 mg/m2/day with a single dose escalation to 200 mg/m2/day in subsequent cycles if no significant toxicity is observed in the first cycle. The dose administered will be determined using the Body Surface Area (BSA) calculated at the beginning of each treatment cycle. Patients will receive a maximum of 12 cycles of Adjuvant Temozolomide.
Locations(5)
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ACTRN12609000485235