Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Stereotactic Conformal Radiotherapy (SCRT) Compared to Conventional Radiotherapy in Minimising Late Sequelae in Children and Young Adults With Brain Tumours: a Randomised Clinical Trial
Brief Summary: Brain tumours are the commonest solid tumours in children and the second most common neoplasms overall in this patient population. Radiotherapy plays an important part in the management in a majority of these tumours. While the cure rates of these tumours, especially the benign and low grade ones are quite encouraging, the treatment itself may lead to some late sequelae, which could have significant implications in the quality of life in these long-term survivors.

Stereotactic conformal radiotherapy (SCRT) is a modern high-precision radiotherapy technique, which reduces the volume of normal brain irradiated and has the capability to minimise the doses to critical structures. The present study is designed to prospectively estimate the incidence and severity of neuropsychological, cognitive and neuroendocrine dysfunction following radiotherapy delivered with conventional and stereotactic techniques and would be one of the most comprehensive studies providing very important longitudinal and reliable data regarding these sequelae. The study involving 200 patients would be to the best of our knowledge not only the largest ever study conducted so far but also the only randomised trial assessing these sequelae in patients receiving focal brain irradiation.

The study also examines whether the physical advantages of modern technological progress translate in clinical benefit. This could have significant implications in the radiotherapeutic management of children and young adults with brain tumours. The study is unique in design in terms of evaluating the efficacy of SCRT with respect to conventional radiotherapy in terms of long term tumour control and treatment related complications.


Options:
A: Arm Label: Observation; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Radiation therapy; Type: EXPERIMENTAL; Interventions: Radiation: radiation therapy | Arm Label: Radiation plus PCV chemotherapy; Type: EXPERIMENTAL; Interventions: Drug: lomustine, Drug: procarbazine hydrochloride, Drug: vincristine sulfate, Radiation: radiation therapy | Intervention Type: DRUG; Name: lomustine; Assigned to Arm(s): Radiation plus PCV chemotherapy | Intervention Type: DRUG; Name: procarbazine hydrochloride; Assigned to Arm(s): Radiation plus PCV chemotherapy | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): Radiation plus PCV chemotherapy | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): Radiation plus PCV chemotherapy, Radiation therapy
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Radiation: Stereotactic Conformal radiotherapy | Arm Label: 2; Type: OTHER; Interventions: Radiation: Conventional radiotherapy | Intervention Type: RADIATION; Name: Stereotactic Conformal radiotherapy; Assigned to Arm(s): 1 | Intervention Type: RADIATION; Name: Conventional radiotherapy; Assigned to Arm(s): 2
C: Arm Label: Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Radiation therapy | Arm Label: Radiotherapy plus Bevacizumab; Type: EXPERIMENTAL; Interventions: Drug: Bevacizumab | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): Radiotherapy plus Bevacizumab | Intervention Type: RADIATION; Name: Radiation therapy; Assigned to Arm(s): Radiotherapy
D: Arm Label: Single arm; Type: EXPERIMENTAL; Interventions: Biological: CAN-2409, Drug: Valacyclovir, Drug: Temozolomide, Radiation: Radiation therapy | Intervention Type: BIOLOGICAL; Name: CAN-2409; Assigned to Arm(s): Single arm | Intervention Type: DRUG; Name: Valacyclovir; Assigned to Arm(s): Single arm | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Single arm | Intervention Type: RADIATION; Name: Radiation therapy; Assigned to Arm(s): Single arm

Answer: B