Nasopharyngeal CarcinomaNCT04351282
SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
A study testing SBRT in people with Nasopharyngeal Carcinoma and Metastasis, run by Fudan University at 1 site in China.
Trial summary
Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Metastasis, Stereotactic Body Radiation Therapy
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 May 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm)
- age 18-70 years old
- Karnofsky scores ≥70
- Estimated life ≥ 6 months
- Adequate organ function including the following: Absolute neutrophil count (ANC) >= 2.0 * 109/l; Platelets count >= 100 * 109/l ;Hemoglobin >= 90 g/dl; Creatinine clearance >= 60 ml/min; For patients without liver metastasis, AST and ALT <= 1.5 times institutional upper limit of normal (ULN), Total bilirubin <= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT <= 3 times institutional upper limit of normal (ULN), Total bilirubin <= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume >700 mL
- Signed written informed consent
Who cannot join
- Patients who achieve complete remission after comprehensive treatment
- Pathology confirmed as second primary tumor
- Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy
- Femoral bone metastasis
- With serious medical complications and contraindications of radiotherapy
- With uncontrollable malignant pleural effusion
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- Positive pregnancy test for women of childbearing age or lactating women
- Uncontrolled or active infections, such as immunodeficiency or HIV infection
- Active mental disorder or other mental disorder that affects the patient's ability to sign informed consent and understanding.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.
Read the detailed description
The eligible patients will receive 4-6 cycles chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors. Then, SBRT for oligometastatic lesions will be assigned to eligible patients. The efficacy and side-effect will be evaluated and analyzed. The relation of liquid biopsy data with treatment outcome（such as EBV DNA, CTCs, CTC subtype，PD-L1 and so on）will be valued.
- Being tested
- SBRT
- Medical subject headings
- Nasopharyngeal Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Experimental | 4-6 cycles of chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors were given. SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From date of diagnosis until the date of death from any cause
Measured: up to 3 years
Secondary outcomes (4)
Progress free survival
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first
Measured: up to 3 years
Previous Metastatic Progression Free Survival
From date of diagnosis until the date of first documented previous metastatic progression or date of death from any cause, whichever came first
Measured: up to 3 years
New Metastatic Free Survival
From date of diagnosis until the date of first documented new metastasis
Measured: up to 3 years
Adverse Event
Number of Participants with acute or late toxicities
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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 Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiayun He, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351282
- Sponsor's protocol ID
- NPC-SBRT
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT for Oligo-metastatic Lesions After Systemic Treatment of Primary Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04351282
- Acronym / sponsor ID
- NPC-SBRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 Apr 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.
Primary metastatic NPC patients received chemotherapy± immunotherapy, radiation for primary tumors and SBRT for metastatic lesions.
Detailed description
The eligible patients will receive 4-6 cycles chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors. Then, SBRT for oligometastatic lesions will be assigned to eligible patients. The efficacy and side-effect will be evaluated and analyzed. The relation of liquid biopsy data with treatment outcome（such as EBV DNA, CTCs, CTC subtype，PD-L1 and so on）will be valued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT | Experimental | Radiation: SBRT4-6 cycles of chemotherapy±immunotherapy and radical radiotherapy for nasopharyngeal tumors were given. SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically conformed initial metastatic non-keratinizing nasopharyngeal carcinoma (according to the 8th edition of AJCC/UICC stage system) and no PD was observed in eligible patients after comprehensive treatment (chemotherapy±immunotherapy+radiotherapy to primary tumor). Then, the metastic lesions were PR/SD, and met the following requirement: the metastatic lesions ≤5 and metastatic organs ≤2, no more than 3 metastastic lesions for a single organ (diameter ≤ 5cm)
- age 18-70 years old
- Karnofsky scores ≥70
- Estimated life ≥ 6 months
- Adequate organ function including the following: Absolute neutrophil count (ANC) >= 2.0 * 109/l; Platelets count >= 100 * 109/l ;Hemoglobin >= 90 g/dl; Creatinine clearance >= 60 ml/min; For patients without liver metastasis, AST and ALT <= 1.5 times institutional upper limit of normal (ULN), Total bilirubin <= 1.5 times institutional ULN; For patients with liver metastasis, AST and ALT <= 3 times institutional upper limit of normal (ULN), Total bilirubin <= 3 times institutional ULN, with normal coagulation function, child-pugh grade A or B, normal liver tissue volume >700 mL
Key exclusion criteria (9 listed)
- Patients who achieve complete remission after comprehensive treatment
- Pathology confirmed as second primary tumor
- Received radiotherapy at the corresponding site before, and overlapped with the site of this radiotherapy
- Femoral bone metastasis
- With serious medical complications and contraindications of 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 |
|---|---|---|
| SBRTSBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment. | Radiation | SBRT |
Primary outcome
Overall survival
Time frame: up to 3 years
From date of diagnosis until the date of death from any cause
4 secondary outcomes
Progress free survival
Time frame: up to 3 years
Previous Metastatic Progression Free Survival
Time frame: up to 3 years
New Metastatic Free Survival
Time frame: up to 3 years
Adverse Event
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Nasopharyngeal Carcinoma and Metastasis, run by Fudan 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 6 inclusion and 9 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 Apr 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 3 years). 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 Apr 2020.