Nasopharyngeal CarcinomaPhase 2NCT04553510
Treatment of Bevacizumab Followed by Steroid in RN
A Phase 2 study testing Bevacizumab and steroid in people with Nasopharyngeal Carcinoma and Adverse Effect of Radiation Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Adverse Effect of Radiation Therapy, Brain Injuries
- What is being tested?
- Bevacizumab and steroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma.
- Prior irradiation >/= 6 months prior to study entry.
- Radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence.
- Age>/= 18 years. Because on dosing or adverse event data are currently not available on the use of bevacizumab in patients <18years old.
- No prior bevacizumab therapy.
- No evidence of very high intracranial pressure that suggests brain hernia and needs surgery.
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- Fertile women who are willing to take contraception during the trial.
- Routine laboratory studies with bilirubin </=2 * upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) < 2 * ULN, creatinine <1.5 * ULN, red-cell count >/= 4,000 per cubic millimeter; white-cell count >/=1500 per cubic millimeter, platelets >/= 75,000 per cubic millimeter; Hb >/=9.0. PT, APTT, INR in a normal range.
- If with history of seizures, patients should be on anticonvulsant therapy. However, preference will be enzyme-non-inducing anticonvulsants.
- Ability to understand and willingness to sign a written informed consent document.
- The patient has no active bleeding or pathological condition that carries a high risk of bleeding; there is no evidence of serious or non-healing wound, ulcer or bone fracture.
Who cannot join
- evidence of metastatic disease;
- evidence of tumor invasion to major vessels(e.g. the carotid);
- history of bleeding related to tumor or radiotherapy during or after the completion of radiation.
- Evidence of active central nervous system hemorrhage.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment.
- inadequately controlled hypertension (systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg despite antihypertensive medication)
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- Severe complications: 1) History of large vessel cerebrovascular accident (CVA) within 6 months; 2) Myocardial infarction or unstable angina within 6 months; 3) New York heart association grade II or greater congestive heart failure; 4) Serious and inadequately controlled cardiac arrhythmia; 5) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 6) Clinically significant peripheral vascular disease; 7) severe infection.
- Evidence of bleeding diathesis or coagulopathy.
- Patients who have received steroid therapy for radiation-induced brain necrosis before the study.
- History of anaphylactic response to bevacizumab.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Tang Yamei, Ph.D, 86-20-81332619
About this study
Official title: Treatment of Bevacizumab Followed by Steroid in Radiation-induceded Brain Injury：a Randomized，Controlled and Single-blind Clinical Trail
Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy
Read the detailed description
Radiation-induced brain injury is a severe complication of radiotherapy in patients with Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. This study is a randomized, single blind clinical study. The primary aim of this study is to determine whether treatment of bevacizumab followed by steroid can alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma, and to compare the treating effect between combination of bevacizumab and steroid and bevacizumab alone.
- Being tested
- Bevacizumab and steroid, Bevacizumab and placebo
- Medical subject headings
- Nasopharyngeal Carcinoma, Radiation Injuries, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab and steroidDrug
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
Bevacizumab and placeboDrug
Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and steroid | Experimental | Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks. Receives: Drug: Bevacizumab and steroid |
| Bevacizumab and placebo | Active comparator | Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks. Receives: Drug: Bevacizumab and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients
Change in MRI of radiation-induced brain necrosis in patients
Measured: Change form baseline to evaluation at 12 weeks
Secondary outcomes (2)
Change of neurologic function of patients after treatment
Change of neurologic function assessed using LENT/SOMA sacle of patients after treatment
Measured: Change from baseline to evaluation at 12 weks.
Change of quality of life of patients after treatment
Change of quality of life using QOL scale of patients after treatment
Measured: Change from baseline to evaluation at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Jan 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Tang Yamei, Ph.D, Study director, sun yat-sen memorial hospital,sun yat-sen universicy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553510
- Sponsor's protocol ID
- 20160101
- Other IDs
- SYS-2016004
- Status last verified
- Sep 2020
- First submitted
- 5 May 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bevacizumab Followed by Steroid in Radiation-induceded Brain Injury：a Randomized，Controlled and Single-blind Clinical Trail
- ClinicalTrials.gov ID
- NCT04553510
- Acronym / sponsor ID
- 20160101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy
Detailed description
Radiation-induced brain injury is a severe complication of radiotherapy in patients with Nasopharyngeal carcinoma. Current neuroprotective therapies show limited benefit in ameliorating this complication of radiotherapy. This study is a randomized, single blind clinical study. The primary aim of this study is to determine whether treatment of bevacizumab followed by steroid can alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma, and to compare the treating effect between combination of bevacizumab and steroid and bevacizumab alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and steroid | Experimental | Drug: Bevacizumab and steroidBevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks. |
| Bevacizumab and placebo | Active comparator | Drug: Bevacizumab and placeboBevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have received radiotherapy for histologically confirmed nasopharyngeal carcinoma.
- Prior irradiation >/= 6 months prior to study entry.
- Radiographic evidence to support the diagnosis of radiation-induced brain necrosis without tumor recurrence.
- Age>/= 18 years. Because on dosing or adverse event data are currently not available on the use of bevacizumab in patients <18years old.
- No prior bevacizumab therapy.
Key exclusion criteria (10 listed)
- evidence of metastatic disease;
- evidence of tumor invasion to major vessels(e.g. the carotid);
- history of bleeding related to tumor or radiotherapy during or after the completion of radiation.
- Evidence of active central nervous system hemorrhage.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to study enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab and steroidBevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks. | Drug | Bevacizumab and steroid |
| Bevacizumab and placeboBevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks. | Drug | Bevacizumab and placebo |
Primary outcome
Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients
Time frame: Change form baseline to evaluation at 12 weeks
Change in MRI of radiation-induced brain necrosis in patients
2 secondary outcomes
Change of neurologic function of patients after treatment
Time frame: Change from baseline to evaluation at 12 weks.
Change of quality of life of patients after treatment
Time frame: Change from baseline to evaluation at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tang Yamei, Ph.D study director
sun yat-sen memorial hospital,sun yat-sen universicy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and steroid in people with Nasopharyngeal Carcinoma and Adverse Effect of Radiation Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tang Yamei, Ph.D (86-13556001992, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients (time frame: Change form baseline to evaluation at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.