Nasopharyngeal CarcinomaPhase 2NCT03058432
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Radiotherapy alone and Concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Radiotherapy alone and Concurrent chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma
Who cannot join
- A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaozhong Chen
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, +86-571-88128202, cxzfyun@sina.com
About this study
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Read the detailed description
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Radiotherapy alone, Concurrent chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy aloneRadiation
Concurrent chemoradiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Intensity-modulated Radiotherapy | Experimental | Radiotherapy alone was given. Receives: Radiation: Radiotherapy alone |
| Concurrent chemoradiotherapy | Active comparator | Concurrent cisplatin-based radiotherapy was given. Receives: Radiation: Concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic success
A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.
Measured: From date of treatment until the date of completing treatment 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (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 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Concurrent cisplatin based chemoradiotherapy versus radiotherapy alone
- Masking
- None (open label)
- Enrolment
- 122 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
- NCT03058432
- Sponsor's protocol ID
- ZJCH-2016-HN03
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03058432
- Acronym / sponsor ID
- ZJCH-2016-HN03
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Feb 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.
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Detailed description
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Concurrent cisplatin based chemoradiotherapy versus radiotherapy alone
| Arm | Type | Receives |
|---|---|---|
| Intensity-modulated Radiotherapy | Experimental | Radiation: Radiotherapy aloneRadiotherapy alone was given. |
| Concurrent chemoradiotherapy | Active comparator | Radiation: Concurrent chemoradiotherapyConcurrent cisplatin-based radiotherapy was given. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma
Key exclusion criteria (1 listed)
- A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
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 |
|---|---|---|
| Radiotherapy alone | Radiation | Intensity-modulated Radiotherapy |
| Concurrent chemoradiotherapy | Radiation | Concurrent chemoradiotherapy |
Primary outcome
therapeutic success
Time frame: From date of treatment until the date of completing treatment 1 month later
A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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 Radiotherapy alone and Concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma, 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 1 inclusion and 1 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 23 Feb 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
therapeutic success (time frame: From date of treatment until the date of completing treatment 1 month later). 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 23 Feb 2017.