- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119674
Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma
September 19, 2023 updated by: Chen yuanyuan, Zhejiang Cancer Hospital
Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma
The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Yuanyuan, MD
- Phone Number: 08613738103808
- Email: chenyy@zjcc.org.cn
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
- 2 ~ 6 weeks after operation; the surgical incision healed well;
- Presence of lesions evaluable according to Rano criteria;
- Aged 18-70 years;
- Karnofsky performance status (KPS) ≥ 60;
- The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
- No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
- Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
- Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
- Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
- Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
- Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
- Patient is sufficiently compliant with study and follow-up procedures;
- Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.
Exclusion Criteria:
- Secondary glioblastoma;
- Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
- Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
- Pregnant or lactating women;
- Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
- Evidence of hereditary bleeding constitution or coagulation disorders;
- Patients requiring anticoagulant therapy due to other diseases;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single-arm
single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0
Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
|
Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0
Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.
Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy.
One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .
Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy.
Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: from enrollment to progression or death (for any reason),assessed up to 18months
|
Progression-Free Survival
|
from enrollment to progression or death (for any reason),assessed up to 18months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: from enrollment to death (for any reason).assessed up to 24 months
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Overall Survival
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from enrollment to death (for any reason).assessed up to 24 months
|
adverse event
Time Frame: from enrollment to death (for any reason).assessed up to 24 months
|
Adverse events are described in terms of CTC AE 5.0
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from enrollment to death (for any reason).assessed up to 24 months
|
Health-related quality of life
Time Frame: from enrollment to death (for any reason).assessed up to 24 months
|
Health-related quality of life are measured by the EORTC-QL30/BN20.
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from enrollment to death (for any reason).assessed up to 24 months
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Neurocognitive function
Time Frame: from enrollment to death (for any reason).assessed up to 24 months
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Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE).
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from enrollment to death (for any reason).assessed up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chen Ming, Zhejiang Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2019
Primary Completion (Actual)
August 23, 2022
Study Completion (Actual)
August 23, 2022
Study Registration Dates
First Submitted
October 6, 2019
First Submitted That Met QC Criteria
October 6, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
Other Study ID Numbers
- GBM-AS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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