Radiation InjuriesPhase 2NCT03208413
The Therapeutic Effect of Thalidomide in RI
A Phase 2 study testing Thalidomide in people with Radiation Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
Trial summary
Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in radiation-induced brain injury. Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Radiation Injuries
- What is being tested?
- Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesChina
- Study dates
- 19 Jul 2017to 30 Jul 2020
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior irradiation >/= 12 months prior to study entry.
- Radiographic evidence to support the diagnosis of radiation-induced brain injury without tumor recurrence.
- Age>/= 35 years.
- Contraindication to glucocorticoids and bevacizumab treatment due to history or high risk of severe adverse effects, or non-effective response to glucocorticoids and bevacizumab treatment in 12 months prior to study entry.
- Estimated life expectancy must be greater than 12 months.
- Routine laboratory studies: bilirubin </=1.0 * upper limits of normal (ULN); aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)< 1.0 * ULN; creatinine <1.0 * ULN; white-cell count >/= 4,000 per cubic millimeter; neutrophils count >/=1500 per cubic millimeter platelets >/= 100,000 per cubic millimeter; Hb >/=110 gram per millilitres; PT, APTT, INR in a normal range.
- Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.
Who cannot join
- Evidence of tumor metastasis, recurrence, or invasion;
- Current usage of bevacizumab;
- Current usage of glucocorticoids;
- Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- History of psychiatric diseases before radiotherapy;
- History of seizures;
Show all 19Show fewer
- History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months;
- New York Heart Association Grade II or greater congestive heart failure;
- Serious and inadequately controlled cardiac arrhythmia;
- Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection;
- Severe infection;
- History of allergy to relevant drugs;
- Pregnancy, lactation, or fertility program in the following 12 months;
- History or current diagnosis of peripheral nerve disease;
- Abnormal in liver and renal function;
- Active tuberculosis;
- Transplanted organs;
- Human immunodeficiency virus;
- Participation in other experimental studies.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Cancer canter of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Mingyuan Chen, M.D., Ph.D., 86-15692015027, 406143748@qq.com
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., Ph.D., 86-13556001992, yameitang@hotmail.com
Yi Li, M.D., Ph.D.
- Recruiting
Guangzhou Huiai Hospital
Guanzhou, Guangdong, 510000
Dong Zheng, 920905565@qq.com
About this study
Official title: The Effect of Thalidomide in Radiation-induced Brain Injury（RI）: a Phase II Clinical Trial
Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in radiation-induced brain injury.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: The primary endpoint is the brain injury remission at week 15. In brief, the brain lesion will be evaluated by using brain MRI scan before and after thalidomide regimen. The clinical efficacy is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage.
Read the detailed description
There is no acknowledged and effective standard treatment for radiation-induced brain injury (RI). Glucocorticoids and bevacizumab during acute period are optional ways to reduce the brain edema. However, glucocorticoids and bevacizumab are unsuitable or ineffective for some patients, especially in the early stage of RI. The investigators supposed that angiogenesis might play a key role in the pathogenesis of RI, and that thalidomide, as an antiangiogenic drug, would reduce immature angiogenesis and improve vessel maturation in RI.
Primary objectives: This phase II clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in radiation-induced brain injury.
OUTLINE: This is a phase II, open-label, single arm clinical trial. Patients are enrolled and administrated with thalidomide. Thalidomide is supplied as 25 mg per pill to be taken by mouth.
Arm І: Patients receive thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
- Conditions
- Radiation Injuries
- Being tested
- Thalidomide
- Keywords
- thalidomide, radiation-induced brain injury
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
| Study group | Role | What they receive |
|---|---|---|
| thalidomide | Experimental | Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration. Receives: Drug: Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
the brain injury remission
The brain injury remission is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage
Measured: Week 15
Secondary outcomes (2)
improvement of quality of life
the difference value of WHO-QOL scale before and after thalidomide regimen
Measured: Week 15
improvement of neurological function
the difference value of LENT/SOMA scales before and after thalidomide regimen
Measured: Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start19 Jul 2017
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation InjuriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 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
- Yamei Tang, M.D., Ph.D., Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208413
- Sponsor's protocol ID
- 2017001
- Status last verified
- Nov 2019
- First submitted
- 8 May 2017
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng J, Jiang J, He B, Lin WJ, Li Y, Duan J, Li H, Huang X, Cai J, Xie J, Zhang Z, Yang Y, Xu Y, Hu X, Wu M, Zhuo X, Liu Q, Shi Z, Yu P, Rong X, Ye X, Saw PE, Wu LJ, Simone CB 2nd, Chua MLK, Mai HQ, Tang Y. A phase 2 study of thalidomide for the treatment of radiation-induced blood-brain barrier injury. Sci Transl Med. 2023 Feb 22;15(684):eabm6543. doi: 10.1126/scitranslmed.abm6543. Epub 2023 Feb 22.
PubMed 36812346
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thalidomide in Radiation-induced Brain Injury（RI）: a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03208413
- Acronym / sponsor ID
- 2017001
- Conditions
- Radiation Injuries
- Keywords
- thalidomide, radiation-induced brain injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 5 Jul 2017 (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.
Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in radiation-induced brain injury.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: The primary endpoint is the brain injury remission at week 15. In brief, the brain lesion will be evaluated by using brain MRI scan before and after thalidomide regimen. The clinical efficacy is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage.
Detailed description
There is no acknowledged and effective standard treatment for radiation-induced brain injury (RI). Glucocorticoids and bevacizumab during acute period are optional ways to reduce the brain edema. However, glucocorticoids and bevacizumab are unsuitable or ineffective for some patients, especially in the early stage of RI. The investigators supposed that angiogenesis might play a key role in the pathogenesis of RI, and that thalidomide, as an antiangiogenic drug, would reduce immature angiogenesis and improve vessel maturation in RI.
Primary objectives: This phase II clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in radiation-induced brain injury.
OUTLINE: This is a phase II, open-label, single arm clinical trial. Patients are enrolled and administrated with thalidomide. Thalidomide is supplied as 25 mg per pill to be taken by mouth.
Arm І: Patients receive thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thalidomide | Experimental | Drug: ThalidomideThalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prior irradiation >/= 12 months prior to study entry.
- Radiographic evidence to support the diagnosis of radiation-induced brain injury without tumor recurrence.
- Age>/= 35 years.
- Contraindication to glucocorticoids and bevacizumab treatment due to history or high risk of severe adverse effects, or non-effective response to glucocorticoids and bevacizumab treatment in 12 months prior to study entry.
- Estimated life expectancy must be greater than 12 months.
Key exclusion criteria (19 listed)
- Evidence of tumor metastasis, recurrence, or invasion;
- Current usage of bevacizumab;
- Current usage of glucocorticoids;
- Evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- History of psychiatric diseases before radiotherapy;
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 |
|---|---|---|
| ThalidomideThalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration. | Drug | thalidomide |
Primary outcome
the brain injury remission
Time frame: Week 15
The brain injury remission is defined as ≥ 25% reduction in brain edema volume on FLAIR images at week 15, as compared with that before thalidomide usage
2 secondary outcomes
improvement of quality of life
Time frame: Week 15
improvement of neurological function
Time frame: Week 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 36812346Cheng J, Jiang J, He B, Lin WJ, Li Y, Duan J, Li H, Huang X, Cai J, Xie J, Zhang Z, Yang Y, Xu Y, Hu X, Wu M, Zhuo X, Liu Q, Shi Z, Yu P, Rong X, Ye X, Saw PE, Wu LJ, Simone CB 2nd, Chua MLK, Mai HQ, Tang Y. A phase 2 study of thalidomide for the treatment of radiation-induced blood-brain barrier injury. Sci Transl Med. 2023 Feb 22;15(684):eabm6543. doi: 10.1126/scitranslmed.abm6543. Epub 2023 Feb 22.
- Individual participant dataSharing planned: Undecided
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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.
Yamei Tang, M.D., Ph.D. study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with Radiation Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites 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 7 inclusion and 19 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Yamei Tang, M.D., 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?
the brain injury remission (time frame: Week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208413, which also lists 1 linked publication.
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 22 Nov 2019.