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NCT Number: NCT05124951

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

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

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Key information

Conditions

Intracranial Germ Cell CNS Tumor, Childhood

Age range

3 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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<serum/CSF β-HCG <500IU/L without histology
  • Mature teratoma with normal AFP and β-HCG <500IU/L
  • Inadequate organ function
  • Poor compliance

Treatment and study plan

Whole-ventricle irradiation

Radiation

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

Carboplatin/etoposide

Drug

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

Ifosfamide/cisplatin/etoposide

Drug

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

Second-look surgery

Procedure

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

Primary outcomes

  1. 3-year event-free survival

    Time frame: From the enrollment to the event (relapse or death of any cause), approximately 3 years. The patients will receive long-term follow-up including MRI and serum tumor markers examination every 3 months until 36 months.

    Event-free survival (DFS) is calculated from the date of enrollment to the date of an event (relapse or death of any cause).

  2. Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition)

    Time frame: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment

    The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL. (age ≤18 years)

  3. Change of score of the QoL questionnaire (Short form-36)

    Time frame: Evaluation will be conducted at baseline, 6 months posttreatment, yearly through 3 years posttreatment

    Altogether, 36 questions with standardized response choices were organized into eight scales, including physical functioning (PF), role limitations as a result of physical health problems (RP), body pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations as a result of emotional problems (RE), and general mental health (MH). Additionally, reported health transition (HT) was used to evaluate general health changes during the previous year. The raw scores were converted to a 0-100 scale according to the instructions, and higher scores indicated a better HRQOL. Physical component score (PCS) and mental component score (MCS) were also calculated. (Age >15 years)

  4. Change of score of Chinese Wechsler Intelligence Scale for Children

    Time frame: Score will be obtained at baseline, 6 months posttreatment, yearly through 3 years posttreatment

    The intelligence of the child was tested by the China-Wechsler Intelligence Scale for Children (C-WISC), which was revised by Gong and Cai at Hunan Medical University. The C-WISC consists of 11 individual tests that include six verbal tests [Information (I), Comprehend (C), Sorting (S), Arithmetic (A), Vocabulary (V), and Digit symbol (D)] and five performance tests [Picture Completing (PC), Picture Arrangement (PA), Block Pattern (BP), Object Assembly (OA), and Coding (CD)]. Based on individual testing, vocabulary scores (V), procedure scores (P), and full scores (F) were obtained. Furthermore, the VIQ, PIQ, and full intelligence quotient (FIQ) were calculated progressively .

Secondary outcomes

  1. 3-year overall survival

    Time frame: From the enrollment to the death of any cause or last follow-up, approximately 3 years.The patients will receive long-term follow-up including MRI and serum tumor markers examination every 3 months until 36 months.

    Overall survival is determined from the date of diagnosis to the date of death of any cause or the last follow-up visit

  2. Short-term adverse effects of treatments

    Time frame: From the beginning to the completion of chemoradiotherapy, approximately 6 months. Grade 3/4 toxicities will be documented

    NCI CTCAE 5.0 will be used for adverse effects evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Li, MD,PhD

CONTACT

[email protected]

(86)10-59975581

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.