Nasopharyngeal CarcinomaPhase 2NCT03025958
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Nimotuzumab and Radiation in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Radiation Plus Concurrent Nimotuzumab in 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?
- Nimotuzumab and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2017to 30 Dec 2023
- 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.
About this study
Official title: Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Read the detailed description
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Nimotuzumab, Radiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Also called humanized anti-epidermal factor receptor monoclonal antibody h-R3
Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
RadiationRadiation
Briefly, the dose prescribed was 70.4 Gy, 70.4 Gy, 60.8 Gy, and 54.4 Gy in 32 fractions delivered over 6 weeks at the periphery of the planning target volume (PTV)nx+rn, PTVnd, PTV1, and PTV2, respectively, using the simultaneous integrated boost technique.
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Experimental | Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week). Receives: Drug: Nimotuzumab; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response (CR) rate at 1 month after radiotherapy
CR was defined as a complete lack of unequivocal soft tissue mass in the primary site and cervical lymph nodes with a short axis of less than 10 mm assessed by fiber-optic nasopharyngoscopy and MRI of the head and neck according to the Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST V.1.1).
Measured: 1 month after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start13 Mar 2017
- Primary completion12 Nov 2018
- Study completion30 Dec 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
- Investigators
- Xiaozhong Chen, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025958
- Sponsor's protocol ID
- ZJCH-2016-HN04
- Status last verified
- May 2024
- First submitted
- 10 Jan 2017
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03025958
- Acronym / sponsor ID
- ZJCH-2016-HN04
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Detailed description
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT.
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Experimental | Drug: Nimotuzumab, Radiation: RadiationElderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week). |
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 |
|---|---|---|
| NimotuzumabAlso: humanized anti-epidermal factor receptor monoclonal antibody h-R3Concomitant nimotuzumab was given weekly at a dose of 200 mg from one week before the start of IMRT. | Drug | Nimotuzumab |
| RadiationBriefly, the dose prescribed was 70.4 Gy, 70.4 Gy, 60.8 Gy, and 54.4 Gy in 32 fractions delivered over 6 weeks at the periphery of the planning target volume (PTV)nx+rn, PTVnd, PTV1, and PTV2, respectively, using the simultaneous integrated boost technique. | Radiation | Nimotuzumab |
Primary outcome
Complete response (CR) rate at 1 month after radiotherapy
Time frame: 1 month after radiotherapy
CR was defined as a complete lack of unequivocal soft tissue mass in the primary site and cervical lymph nodes with a short axis of less than 10 mm assessed by fiber-optic nasopharyngoscopy and MRI of the head and neck according to the Response Evaluation Criteria in Solid Tumors V.1.1 (RECIST V.1.1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- 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.
Xiaozhong Chen, MD principal investigator
Zhejiang Cancer Hospital
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 Nimotuzumab and Radiation 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: finished, as of the sponsor's last update on 6 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response (CR) rate at 1 month after radiotherapy (time frame: 1 month after radiotherapy). 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 6 May 2024.