NCT06929819Not yet recruiting
Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
According to the latest national cancer statistics released by the National Cancer Center in February 2022, intracranial tumors account for about 60%-70% of the more than 3.5 million cancer patients, and the morbidity and mortality remain high. Intracranial malignant tumors have become a problem that needs to be solved urgently because of their early recurrence, rapid progression, and short survival, and intracranial malignant tumors include high-grade gliomas, metastases, lymphomas, etc. Glioblastoma (GB) is the most common primary malignancy in the adult central nervous system, accounting for about 57% of all gliomas and 48% of all primary weighted nervous system malignancies. At present, the standard treatment for glioblastoma is mainly surgical treatment, supplemented by postoperative concurrent chemoradiotherapy and adjuvant chemotherapy, but the prognosis of patients is still poor, with a one-year survival rate of 40.6%, a five-year survival rate of only 5.6%, and an average survival time of 12-15 months. For patients diagnosed with intracranial malignancies (including high-grade glioma, metastases, lymphoma, etc.), multimodal image-guided microsurgery combined with postoperative chemoradiotherapy recommended by the guidelines, and intraoperative radiotherapy with tumor bed radiation therapy to achieve targeted and precise tumor treatment, thereby improving the prognosis of patients (including progression-free survival and median overall survival, etc.)
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2027
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Glioblastoma
- NCT number
- NCT06929819
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Jun 2025 to the primary completion date, 31 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refuse to undergo craniotomy or radiation therapy;
Other illness
- The postoperative paraffin pathological results were not high-grade gliomas or other cranial malignant tumors;
Other
- Refuse to participate in the clinical trial after informed consent without the above exclusion criteria.
Who the study is looking for
- 18-75 years old, non-pregnant or lactating women
- KPS ≥60
- MRI and CT of the brain with contrast should be considered for diagnosis of high-grade glioma or other malignant brain tumors
- No other underlying diseases that affect survival time, follow-up or quality of life, and no other serious organic lesions
- Not receive radiotherapy, chemotherapy and other treatment methods for intracranial lesions in the past;
- Tumor located supratentorium, and the position should ensure that the tumor resection volume is more than 90%;
- The required dose of standard radiotherapy exceeds normal tissue tolerance
- No related contraindications such as intraoperative radiotherapy and craniotomy.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.