Development of Asian Consortium for Data Collection and Clinical Trial of CNS Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiation Therapy: Radiation Therapy(General guideline) Patients will receive radiotherapy after induction chemotherapy or right after diagnosis without diagnosis. The dose and fields of radiation will be according to the histology, presence of dissemination, and response to the induction chemotherapy or radiotherapy. Radiation therapy can be administered using either of photons or protons. When induction chemotherapy is administered, radiotherapy is recommended to be started within 6 weeks from the last chemotherapy.

Study summary

\<Purpose of the Research\>

* Primary Establishing an Asian consortium to establish a database of pediatric CNS tumors in the prospective manner The target disease of this research focuses on pediatric tumors, and initially the registration of patients with CNS GCT will begin first.
* Secondary Developing clinical protocols for pediatric CNS tumors based in Asia

\<Duration of Research Participation\> Registration period for research subjects: 2022-08-01 - 2027-12-31 Duration of medical records to be utilized: to 2030-12-31 Total projected duration of research: IRB approved to 2032-12-31 Interim assessment of data quality and integrity: 6 Mo after Data collection Evaluation for the Adaptation of Protocols: 1 and 2 years after the initiation of the study Analysis of Quality of Life and other questionnaires: 3 and 5 years Interim Analysis of all data: 5 years (2027) Final analysis of treatment outcome: 2032

Eligibility

Primary outcome measure(s)

• Demographic and diagnostic elements — Untill the year 2027
  * Sex, date of birth, birth order, weight at birth, education, disability diagnosis, parents' socio-economic information, cancer family history * Age at diagnosis, date of diagnosis, name of diagnosis, pathological name of the diagnosis, ECOG performance status at the time of diagnosis, location of tumor, stage, tumor marker, biopsy, etc.
• Laboratory and pathologic assessments — Untill the year 2027
  * Laboratory assessments include full blood count, PT, PTT, serum electrolytes, alakaline phosphatase, alanine transferase, aspartate aminotransferase, bilirubin, serum creatinine, GFR, serum lactate, and ammonium. * Both of serum and CSF tumor markers including bHCG and AFP are highly recommended to be obtained at the time of diagnosis. Tumor markers in both serum and CSF should be obtained within 3 months after the completion of radiotherapy for final response evaluation. * Biopsy is strongly recommended as a component of diagnostic assessments, even when germinoma is highly suspected based on radiological images and tumor markers. Biopsy is particularly strongly recommended when ß-HCG is higher than 50 mIU/mL.
• Radiological assessments — Untill the year 2027
  * Brain and spinal MRI with gadolinium contrast should be obtained at the time of diagnosis. * For early response evaluation, brain MRI is highly recommended to be obtained at radiation dose of 20 Gy in patients who are not given induction chemotherapy. Otherwise, brain MRI should be obtained after induction chemotherapy and before the initiation of radiotherapy. * For final response evaluation, brain MRI should be obtained within 3 months after the completion of radiotherapy.
• Radiologic response criteria — Untill the year 2027
  * Complete response (CR): complete disappearance of visible disease on imaging. allowing for minimal residual disease/enhancement ≤0.5 cm maximal dimension in suprasellar or ≤1cm in pineal locations. * Partial response (PR): \> 0.5 cm dimension residual in the suprasellar area or \> 1 cm residual in pineal location, but ≥ 65% decrease in the sum of the products of the three perpendicular diameters (volume) of all target lesions. * Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesion to qualify for PD, and residual disease of \> 1.5 cm maximal diameter. * Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters (volume) of any target lesion, or the appearance of one or more new lesions.
• Treatment elements — Untill the year 2027
  * Whether the operation has been performed and the extent of operation if performed * Chemotherapy: Medication used for treatment, treatment response, the timing of treatment (pre- or post-radiation therapy) * Radiation therapy: Site of treatment, treatment volume (radiotherapy field), radiation dose, treatment response, start date, end date
• Treatment response, acute and late complications, and survival — Untill the year 2027
  * Treatment response (by radiologic imaging, tumor markers), treatment-related acute and late complications, co-morbid condition, last traced date, whether the patient survived or not * Whether the disease relapsed, the date of relapse, the location of relapse (brain or spine, out or inside of final boost field, out or inside of whole ventricular field) * Development of second malignant neoplasm (SMN)

Trial sites (1)

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