Enhanced treatment for newly diagnosed glioblastoma after surgery

Enhanced Adjuvant Therapy for Newly Diagnosed Glioblastoma With Partial Surgical Resection or Short-term Progression: a Bayesian Adaptive Randomized Phase II Study

This study is testing a new treatment plan for people with newly diagnosed glioblastoma after surgery to see if a combination of different drugs and higher radiation doses works better than the usual care.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Hangzhou)
• Trial ID: NCT06936046 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates an enhanced adjuvant therapy for patients with newly diagnosed glioblastoma who have undergone partial surgical resection or experienced short-term progression. Participants will be randomly assigned to either the standard Stupp regimen or an experimental group receiving a combination of different drugs and increased radiation doses. The study aims to enroll 210 patients, with screening and evaluation conducted prior to randomization. Informed consent will be obtained from all participants before the screening process begins.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a pathologically diagnosed glioblastoma who have undergone partial surgical resection or have experienced short-term progression.

Not a fit: Patients with severe organ dysfunction or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with glioblastoma.

How similar studies have performed: Other studies have shown promise with enhanced adjuvant therapies for glioblastoma, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation in clinical research: fully understand and be informed of this study, and sign a written informed consent form; Willing to follow and capable Complete all experimental procedures.
2. Age: ≥ 18 years old, both male and female are acceptable.
3. Pathologically diagnosed GBM patients
4. Partial surgical resection or recurrence and progression 2-6 weeks after surgery (before radiotherapy)
5. Adequate organ and bone marrow function, without severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction, or immune deficiency:

   1. Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 \* 109/L (1500/mm3), platelets ≥ 75 \* 109/L, hemoglobin ≥ 9 g/dL (if bone marrow is involved, platelets ≥ 50 \* 109/L, ANC ≥ 1.0 \* 109/L, hemoglobin ≥ 8 g/dL).
   2. Liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal value (AST is allowed if there is liver involvement, ALT ≤ 5 times the upper limit of normal value).
   3. Renal function: Serum creatinine ≤ 1.5 times the upper limit of normal value.
   4. Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT and APTT are ≤ 1.5 times the upper limit of normal values (unless the subject is receiving anticoagulant treatment and PT and APTT are within the expected range of anticoagulant treatment at the time of screening).
6. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.
7. The serum pregnancy test is negative, and effective contraceptive measures have been taken from the signing of the informed consent form until 6 months after the last chemotherapy.
8. Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free triiodothyronine (FT3) are all within the normal range of ± 10%.
9. Ophthalmic examination: including dilated pupil fundus examination, slit lamp examination, and fundus color photography.

Exclusion Criteria:

* 1\) Currently participating in other clinical studies, or less than 4 weeks after the end of treatment in the previous clinical study.

  2\) In the past 3 years, there has been a history of malignant tumors other than GBM, or other primary malignant tumors that have not been cured.

  3\) Previous history of brain radiation therapy. 4) Pregnant or lactating women. 5) After evaluation, there are patients with contraindications to radiotherapy. 6) Serious active comorbidities that may affect the treatment of this study. 7) Active infections that require systematic anti infective treatment, including but not limited to bacterial, fungal, or viral infections.

  8\) Patients with heart failure, unstable angina, severe uncontrolled ventricular arrhythmias, acute ischemia or myocardial infarction as determined by the New York Heart Association (NYHA) functional classification within the first 6 months of screening.

  9\) QTcF interval\>480milliseconds, unless secondary to bundle branch block. 10) Suffering from uncontrollable comorbidities, including but not limited to uncontrolled hypertension, active peptic ulcers, or bleeding disorders.

  11\) Individuals with a history of mental illness in the past; Individuals without legal capacity or with limited legal capacity.

  12)Medical history or disease evidence that may interfere with the trial results, hinder the subjects' full participation in the study, abnormal treatment or laboratory test values, or other situations that the researchers consider unsuitable for inclusion.

Where this trial is running

Hangzhou

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Ting Zhang

Conditions Glioblastoma