Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery:Study protocol for a randomized controlled clinical trial
Abstract Abstract Background It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide (TMZ) can improve PFS and OS in patients with high-risk low-grade gliomas (LGGs). Methods/design This is a two-group, randomized controlled trial (RCT) enrolling patients who have low-grade (WHO grade 2) gliomas aged 40 years or older without regard to the extent of resection or younger than 40 years old with subtotal resection or biopsy. Eligible participants will be randomly assigned to receive radiation therapy (RT) alone or RT plus temozolomide chemotherapy in a 1:1 ratio. The same RT will be given to all eligible participants regardless of whether they are randomly assigned to RT group or chemoradiotherapy (CRT) group. While in the CRT group, patients will receive adjuvant TMZ with or without concurrent radiochemotherapy. The primary outcome of this trial is progression-free survival and it will be analyzed by intention-to-treat (ITT). Secondary outcomes include OS, adverse events and cognitive function (CF). Discussion The objective of our research is to assess the effect of radiotherapy coupled with temozolomide in high-risk LGGs after surgery, compared with RT alone. Different histological types and molecular subtypes will be examined and subgroup analysis will be conducted based on them. Our data can provide evidence for postoperative adjuvant therapy in Chinese high-risk LGGs. Trial Registration Chinese Clinical Trial Registry, ChiCTR1800015199. Registered on 13th March, 2018. http://www.chictr.org.cn