Nasopharyngeal CancerPhase 2NCT03129412
Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions
A Phase 2 study testing radical radiotherapy in people with Nasopharyngeal Cancer and Neoplasm Metastasis, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancer, Neoplasm Metastasis
- What is being tested?
- radical radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2017to 23 Apr 2025
- 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
- Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
- Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
- The metastatic lesions ≤5 and metastatic organs ≤2
- Karnofsky scores >70
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
- Informed consent signed.
Who cannot join
- Histologically conformed initial keratinizing carcinoma or others.
- The metastatic lesions >5 or metastatic organs >2.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- History of malignant tumors.
- Pregnant or nursing women.
- History of radiotherapy or chemotherpy in head and neck regions.
- Patients refused the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Shuan Huang, +8618258111085, huangshuang@zjcc.org.cn
About this study
Official title: The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions
Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.
Read the detailed description
The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.
- Conditions
- Nasopharyngeal Cancer, Neoplasm Metastasis
- Being tested
- radical radiotherapy
- Medical subject headings
- Nasopharyngeal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radical radiotherapyRadiation
radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy. Receives: Radiation: radical radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Events of death caused by any reasons
Measured: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (1)
Progress free survival
adverse event including death, recurrence and metastases.
Measured: From date of diagnosis until the date of first documented progression, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start14 Apr 2017
- Primary completion23 Apr 2023 (estimated)
- Study completion23 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129412
- Sponsor's protocol ID
- NPC-Oligo-M
- Status last verified
- Sep 2020
- First submitted
- 12 Apr 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- The Clinical Curative Efficacy and Side Effect of Oligo-metastases Nasopharyngeal Carcinoma Patients Received Radical Radiation for Primary Tumors and Treatments for Metastatic Lesions
- ClinicalTrials.gov ID
- NCT03129412
- Acronym / sponsor ID
- NPC-Oligo-M
- Conditions
- Nasopharyngeal Cancer, Neoplasm Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 23 Apr 2023 (estimated)
- Study completion
- 23 Apr 2025 (estimated)
- First posted
- 26 Apr 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.
Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.
Detailed description
The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Radiation: radical radiotherapy4-6 cycles chemotherapy and radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will assigned to those who got PR,SD after chemotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
- Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
- The metastatic lesions ≤5 and metastatic organs ≤2
- Karnofsky scores >70
- Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
Key exclusion criteria (7 listed)
- Histologically conformed initial keratinizing carcinoma or others.
- The metastatic lesions >5 or metastatic organs >2.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- History of malignant tumors.
- Pregnant or nursing women.
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 |
|---|---|---|
| radical radiotherapyradical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy. | Radiation | Arm 1 |
Primary outcome
Overall survival
Time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Events of death caused by any reasons
1 secondary outcome
Progress free survival
Time frame: From date of diagnosis until the date of first documented progression, assessed up to 36 months
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.
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 radical radiotherapy in people with Nasopharyngeal Cancer and Neoplasm Metastasis, run by Zhejiang Cancer Hospital 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 7 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 Shuang Huang, Dr (+8618258111085, huangshuang@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 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 17 Sep 2020.