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The Efficacy of WVI in Patients With Localized Basal Ganglia Intracranial Germ Cell Tumors

Study Purpose

Primary endpoint. 1. three-year disease-free survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation. 2. Health-related quality of life measured by PedsQL 4.0 and SF-36. Second endpoint. 1. three-year overall survival of patients with localized basal ganglia germ cell tumors receiving whole-ventricle irradiation. 2. Adverse effects of chemoradiotherapy measured by NCI CTCAE 5.0

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 30 Years
Gender All
More Inclusion & Exclusion Criteria

Stratum I: germinoma.

Inclusion Criteria:

  • - 3 years ≤ age ≤ 30 years.
  • - Newly diagnosed.
  • - Unilateral basal ganglia/thalamus lesion.
  • - Germinoma：Histologically confirmed; and/or serum and/or CSF beta-HCG elevation (≤50IU/L); AFP negative.
  • - No radiological evidence of additional lesions in the CNS.
  • - Negative CSF cytology test.
  • - Adequate organ function.
  • - Written informed consent.

Exclusion Criteria:

  • - Bilateral basal ganglia/ thalamus lesions.
  • - Synchronous pineal or sellar/suprasellar lesion.
  • - Diabetes insipidus.
  • - With extracranial lesion(s) - Serum/CSF β-HCG >50IU/L without histology.
  • - Mature teratoma with normal tumor markers.
  • - Inadequate organ function.
  • - Poor compliance.
Stratum II: non-germinomatous germ cell tumors.

Inclusion Criteria:

  • - 3 years ≤ age ≤ 30 years.
  • - Newly diagnosed.
  • - Unilateral basal ganglia/thalamus lesion.
  • - NGGCTs: Histologically confirmed; and/or serum and/or CSF AFP elevation; beta-HCG≥500IU/L.
  • - No radiological evidence of additional lesions in the CNS.
  • - Negative CSF cytology test.
  • - Adequate organ function.
  • - Written informed consent.

Exclusion Criteria:

  • - Bilateral basal ganglia/ thalamus lesions.
  • - Synchronous pineal or sellar/suprasellar lesion.
  • - Diabetes insipitus.
  • - With extracranial lesion(s) - 50IU/L
  • - Mature teratoma with normal AFP and β-HCG <500IU/L.
  • - Inadequate organ function.
- Poor compliance

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05124951
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Beijing Tiantan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Tao Jiang, MD, PhD
Principal Investigator Affiliation Beijing Tiantan Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Intracranial Germ Cell CNS Tumor, Childhood
Additional Details

Intracranial germ cell tumors originating from the basal ganglia area are rare, accounting for less than 20% of patients. Radiotherapy played a vital role in the treatment of this malignancy. However, the optimal target volume is still undetermined. Our study regarding relapse patterns of different radiation volumes showed that the ventricular system and ipsilateral frontal lobe were at risk of relapse after focal radiotherapy. Although craniospinal irradiation (CSI) and whole-brain irradiation (WBI) could significantly reduce the relapse in the above areas, the adverse effect on the quality of life is still a concern. As a result, the investigators proposed whole-ventricular irradiation (WVI) in patients with localized basal ganglia germ cell tumors. In order to evaluate its efficacy and safety, the investigators designed this phase II study.

Arms & Interventions

Arms

Experimental: iGCTS

Stratum I (Germinoma) Patients who achieved complete response after induction chemotherapy will receive WVI 2400cGy/15f plus primary boost 640cGy/4f. Stratum II (NGGCTs) At the time of response evaluation before radiotherapy, those with complete response or residue disease <1.5cm will receive WVI 3060cGy/17f plus primary boost 2340cGy/13f.

Interventions

Radiation: - Whole-ventricle irradiation

Whole-ventricle irradiation will be applied in patients with localized basal ganglia germ cell tumors after induction chemotherapy

Drug: - Carboplatin/etoposide

Carboplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia germinoma

Drug: - Ifosfamide/cisplatin/etoposide

Ifosfamide/cisplatin/etoposide regimen is applied as induction chemotherapy in patients with basal ganglia non-germinomatous germ cell tumors.

Procedure: - Second-look surgery

Second-look surgery would be applied to patients who presented residue disease after induction chemotherapy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital

Beijing, , 100070

Site Contact

Bo Li, MD,PhD

[email protected]

(86)10-59975581

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