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

NCT05124951 | Recruiting Phase 2 DMC

• 1 other identifier: CHN-IGCT-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Primary endpoint

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

Conditions

Intracranial Germ Cell CNS Tumor, Childhood

Keywords

intracranial germ cell tumors; basal ganglia; radiotherapy; target volume; quality of life

Outcome Measures

Primary Outcomes (4)

• 3-year event-free survival

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

  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.

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

  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)

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

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

  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)

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

• Change of score of Chinese Wechsler Intelligence Scale for Children

  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 .

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

Secondary Outcomes (2)

• 3-year overall survival

  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.

• Short-term adverse effects of treatments

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

Study Arms (1)

iGCTS

EXPERIMENTAL

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.

Radiation: Whole-ventricle irradiation; Drug: Carboplatin/etoposide; Drug: Ifosfamide/cisplatin/etoposide; Procedure: Second-look surgery

Interventions

Whole-ventricle irradiation RADIATION

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

iGCTS

Carboplatin/etoposide DRUG

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

iGCTS

Ifosfamide/cisplatin/etoposide DRUG

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

iGCTS

Second-look surgery PROCEDURE

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

iGCTS

Eligibility Criteria

• Age: 3 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

RECRUITING

MeSH Terms

Interventions

EC regimen; Ifosfamide; PE regimen; Second-Look Surgery

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Surgical Procedures, Operative

Study Officials

• Tao Jiang, MD, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Li, MD,PhD

CONTACT

(86)10-59975581; libo@bjtth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 18, 2021
• Study Start: September 15, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

CN (1)