Desmoid TumorPhase 3NCT05561036
A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor
A Phase 3 study testing Liposome doxorubicin and Saline Solution in people with Desmoid Tumor, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Desmoid Tumor
- What is being tested?
- Liposome doxorubicin and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2020to 1 Mar 2023
- Phase
- Phase 3
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be confirmed as desmoid tumor by histopathology
- Patients should have measurable lesions defined by RECIST v1.1
- One of the following conditions is satisfied
- The disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics
- Multiple lesions
- The disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary
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- Large tumor or multiple chambers involved
- Imaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)
- The BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:
- NSAIDs can not control pain, and consider increasing the control of narcotic drugs
- Current use of narcotic drugs increased by 30%
- New opioid anesthetics needed
- Patients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2
- Age ≥ 1 year old, male or female
- ECoG score ≤ 2
- Results of laboratory examination during screening: blood routine test: white blood cell count ≥ 3.0x 109 / L, absolute value of neutrophil ≥ 1.5 x 109 / L, platelet count ≥ 100 x 109 / L, hemoglobin ≥ 90 g / L; liver function: total bilirubin Results: serum creatinine ≤ 1.5 times of the upper limit of normal value; patients without liver metastasis had alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times of the upper limit of normal value; patients with liver metastasis had ALT and AST ≤ 5 times of the upper limit of normal value; renal function: serum creatinine ≤ 1.5 times of the upper normal value or creatinine clearance rate ≥ 50 ml / min, and urine protein < 2+
- Female subjects of childbearing age, male subjects and partners of male subjects agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, contraceptive injection or subcutaneous implantation) during the study and within 6 months after the infusion of study drug)
- Understand and accept the requirements of the study, provide written informed consent and authorization for the use and disclosure of protected information, and agree to comply with the research requirements and return to conduct the required visits
Who cannot join
- Pregnant and lactating women, or fertile women who are not willing to take effective contraceptive measures during the study period
- Those who are known to be allergic to liposome doxorubicin or any component of doxorubicin, or have a history of allergy or hypersensitivity to any therapeutic component or structural analogue in this study
- Subjects previously treated with liposomal doxorubicin
- Patients who have used doxorubicin or epirubicin for more than 450 mg / m2 or more than 550 mg / m2 for epirubicin or anthracycline for heart disease
- The subjects did not receive any other drugs or anti-cancer therapy in the study
- It needs to be combined with other anti-tumor drugs
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- Combined with diseases that may affect the subject's condition or ability to conduct the test, or reduce compliance, including but not limited to the following diseases:
- A:Patients with active gastrointestinal bleeding, such as active peptic ulcer, ulcerative enteritis, or Crohn's disease B:Severe cardiac history: congestive heart failure > NYHA grade II; active coronary heart disease (CAD) (myocardial infarction or unstable angina pectoris, cerebrovascular disease patients within 6 months before the start of the study; uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and / or diastolic blood pressure greater than 100 after combination of two or more antihypertensive drugs) MmHg) and history of hypertensive crisis or hypertensive encephalopathy C:Severe liver and kidney disease, serum ast, ALT more than 2 times the upper limit of the normal range, or Cr more than the upper limit of the normal range, total bilirubin > 1.5 times the upper limit of the normal value, patients with liver metastasis, AST and ALT > 5.0 times the upper limit of normal value D:Serious endocrine diseases, uncontrolled diabetes, blood disease, neuropsychiatric disease patients E:Patients with severe immunosuppression or long-term use of corticosteroids or immunosuppressants are known F:Active hemoptysis G:Symptomatic bacterial, fungal or viral infections, including but not limited to HIV, syphilis, or HBV or HCV infection
- Patients who have used other test drugs or devices or participated in other clinical trials within 3 months before the start of this trial
- Patients who were considered unsuitable for the trial due to other reasons
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University cancer center
Guangzhou, Guangdong, 510060
Jin WANG, MD, 020-87343910, wangjinr@sysucc.org.cn
Huaiyuan Xu, M.D., 020-87340519, xuhy@sysucc.org.cn
About this study
Official title: A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor
The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period
Read the detailed description
A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.
- Conditions
- Desmoid Tumor
- Being tested
- Liposome doxorubicin, Saline Solution
- Keywords
- liposome doxorubicin, Desmoid Tumor
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome doxorubicinDrug
Also called liposome adriamycin
Liposome doxorubicin (50mg/m2) or intravenous placebo with a treatment cycle of once every 28 days
Saline SolutionDrug
saline solution
| Study group | Role | What they receive |
|---|---|---|
| Liposome doxorubicin | Experimental | Liposome doxorubicin (50mg/m2) with a treatment cycle of once every 28 days Receives: Drug: Liposome doxorubicin |
| intravenous placebo | Placebo comparator | saline solution Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival Rate
Measured: 24 months
Secondary outcomes (2)
ORR
Overall Response Rate
Measured: 24 months
Patient Reported Outcomes-Common Terminology Criteria in Adverse Events version 5.0
Patient Reported Outcomes-Common Terminology Criteria in Adverse Events version 5.0 was used to evaluate the toxicity. The evaluation time is 2 years. The data of patients who crossover or receive surgical or radiotherapy intervention will be summarized independently of their main research and treatment processes.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start29 Sep 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid TumorStudies of the same condition, open and under way.
- More trials run by 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wang,MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561036
- Sponsor's protocol ID
- B2020-067-01
- Status last verified
- Sep 2022
- First submitted
- 5 Jan 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor
- ClinicalTrials.gov ID
- NCT05561036
- Acronym / sponsor ID
- B2020-067-01
- Conditions
- Desmoid Tumor
- Keywords
- liposome doxorubicin, Desmoid Tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 30 Sep 2022 (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.
The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period
Detailed description
A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposome doxorubicin | Experimental | Drug: Liposome doxorubicinLiposome doxorubicin (50mg/m2) with a treatment cycle of once every 28 days |
| intravenous placebo | Placebo comparator | Drug: Saline Solutionsaline solution |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Must be confirmed as desmoid tumor by histopathology
- Patients should have measurable lesions defined by RECIST v1.1
- One of the following conditions is satisfied
- Patients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2
- Age ≥ 1 year old, male or female
Key exclusion criteria (10 listed)
- Pregnant and lactating women, or fertile women who are not willing to take effective contraceptive measures during the study period
- Those who are known to be allergic to liposome doxorubicin or any component of doxorubicin, or have a history of allergy or hypersensitivity to any therapeutic component or structural analogue in this study
- Subjects previously treated with liposomal doxorubicin
- Patients who have used doxorubicin or epirubicin for more than 450 mg / m2 or more than 550 mg / m2 for epirubicin or anthracycline for heart disease
- The subjects did not receive any other drugs or anti-cancer therapy in the study
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 |
|---|---|---|
| Liposome doxorubicinAlso: liposome adriamycinLiposome doxorubicin (50mg/m2) or intravenous placebo with a treatment cycle of once every 28 days | Drug | Liposome doxorubicin |
| Saline Solutionsaline solution | Drug | intravenous placebo |
Primary outcome
PFS
Time frame: 24 months
Progression Free Survival Rate
2 secondary outcomes
ORR
Time frame: 24 months
Patient Reported Outcomes-Common Terminology Criteria in Adverse Events version 5.0
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposome doxorubicin and Saline Solution in people with Desmoid Tumor, run by 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 18 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 30 Sep 2022. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jin Wang, M.D. (020-87343910, wangjin@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24 months). 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 30 Sep 2022.