Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Phase I/II Study to Evaluate Carbon Ion Radiotherapy Versus Fractionated Stereotactic Radiotherapy in Patients With Recurrent or Progressive Gliomas: The CINDERELLA Trial
Brief Summary: Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis, therefore application of re-irradiation has to be applied cautiously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV tumors.

Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increase relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the Glioblastoma (GBM) cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons.

First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective.

In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy.

Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival.


Options:
A: Arm Label: Carbon Ion Radiotherapy; Type: EXPERIMENTAL; Interventions: Radiation: Carbon Ion Radiotherapy | Arm Label: Standard Treatment: Fractionated Stereotacitc Radiotherapy; Type: ACTIVE_COMPARATOR; Interventions: Radiation: Fractionated Stereotactic Radiotherapy (FSRT) | Intervention Type: RADIATION; Name: Carbon Ion Radiotherapy; Assigned to Arm(s): Carbon Ion Radiotherapy | Intervention Type: RADIATION; Name: Fractionated Stereotactic Radiotherapy (FSRT); Assigned to Arm(s): Standard Treatment: Fractionated Stereotacitc Radiotherapy
B: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Biological: bevacizumab, Drug: lomustine, Genetic: DNA methylation analysis, Other: laboratory biomarker analysis, Procedure: cognitive assessment, Procedure: quality-of-life assessment | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: lomustine, Genetic: DNA methylation analysis, Other: laboratory biomarker analysis, Procedure: cognitive assessment, Procedure: quality-of-life assessment | Intervention Type: BIOLOGICAL; Name: bevacizumab; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: lomustine; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: GENETIC; Name: DNA methylation analysis; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: OTHER; Name: laboratory biomarker analysis; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: PROCEDURE; Name: cognitive assessment; Assigned to Arm(s): Arm 1, Arm 2 | Intervention Type: PROCEDURE; Name: quality-of-life assessment; Assigned to Arm(s): Arm 1, Arm 2
C: Arm Label: NovoTTF-100A device in combination with Temozolomide; Type: EXPERIMENTAL; Interventions: Device: NovoTTF-100A device | Arm Label: Temozolomide alone, as the best known standard of care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Temozolomide | Intervention Type: DEVICE; Name: NovoTTF-100A device; Assigned to Arm(s): NovoTTF-100A device in combination with Temozolomide | Intervention Type: DRUG; Name: Temozolomide; Assigned to Arm(s): Temozolomide alone, as the best known standard of care
D: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Alkylating Agents | Arm Label: Experimental; Type: EXPERIMENTAL; Interventions: Drug: Disulfiram, Dietary Supplement: Copper, Drug: Alkylating Agents | Intervention Type: DRUG; Name: Disulfiram; Assigned to Arm(s): Experimental | Intervention Type: DIETARY_SUPPLEMENT; Name: Copper; Assigned to Arm(s): Experimental | Intervention Type: DRUG; Name: Alkylating Agents; Assigned to Arm(s): Control, Experimental

Answer: A