Nasopharyngeal CarcinomaPhase 3NCT02012062
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
A Phase 3 study testing TPF neoadjuvant chemotherapy, Concurrent chemotherapy with cisplatin during radiotherapy and Concurrent nimotuzumab during radiotherapy in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- TPF neoadjuvant chemotherapy, Concurrent chemotherapy with cisplatin during radiotherapy and Concurrent nimotuzumab during radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Aug 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
- Stage III and IVA/B NPC patients
- KPS >70
- Age between 18-70
- AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min
Who cannot join
- Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
- Prior radiation treatment to the head and neck or any prior chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
Read the detailed description
Scheme:
Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
- Arm nimotuzumab:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- TPF neoadjuvant chemotherapy, Concurrent chemotherapy with cisplatin during radiotherapy, Concurrent nimotuzumab during radiotherapy, Radical radiotherapy
- Keywords
- Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPF neoadjuvant chemotherapyDrug
Concurrent chemotherapy with cisplatin during radiotherapyDrug
Concurrent nimotuzumab during radiotherapyDrug
Radical radiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm Cisplatin | Active comparator | Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT Receives: Drug: TPF neoadjuvant chemotherapy; Drug: Concurrent chemotherapy with cisplatin during radiotherapy; Radiation: Radical radiotherapy |
| Arm Nimotuzumab | Experimental | Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT Receives: Drug: TPF neoadjuvant chemotherapy; Drug: Concurrent nimotuzumab during radiotherapy; Radiation: Radical radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)
Measured: From Day 1 to Day 90 of radiotherapy
Secondary outcomes (2)
PFS
Measured: 3 years
OS
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2016
- Study completionAug 2017
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Province Tumor Hospital, The First Affiliated Hospital of Xiamen University
- Responsible party
- Principal investigator, Lin Kong, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012062
- Sponsor's protocol ID
- NPC-IMRT-N
- Status last verified
- Apr 2019
- First submitted
- 4 Dec 2013
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
- ClinicalTrials.gov ID
- NCT02012062
- Acronym / sponsor ID
- NPC-IMRT-N
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Concurrent chemotherapy, Nimotuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fujian Province Tumor Hospital, The First Affiliated Hospital of Xiamen University
- Study start
- Jul 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 16 Dec 2013 (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.
The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
Detailed description
Scheme:
Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
- Arm nimotuzumab:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Cisplatin | Active comparator | Drug: TPF neoadjuvant chemotherapy, Drug: Concurrent chemotherapy with cisplatin during radiotherapy, Radiation: Radical radiotherapyNeoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT |
| Arm Nimotuzumab | Experimental | Drug: TPF neoadjuvant chemotherapy, Drug: Concurrent nimotuzumab during radiotherapy, Radiation: Radical radiotherapyNeoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
- Stage III and IVA/B NPC patients
- KPS >70
- Age between 18-70
- AGC > 2000, platelets > 100,000, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min
Key exclusion criteria (5 listed)
- Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
- Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
- Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
- Prior radiation treatment to the head and neck or any prior chemotherapy
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 |
|---|---|---|
| TPF neoadjuvant chemotherapy | Drug | Arm Cisplatin, Arm Nimotuzumab |
| Concurrent chemotherapy with cisplatin during radiotherapy | Drug | Arm Cisplatin |
| Concurrent nimotuzumab during radiotherapy | Drug | Arm Nimotuzumab |
| Radical radiotherapy | Radiation | Arm Cisplatin, Arm Nimotuzumab |
Primary outcome
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)
Time frame: From Day 1 to Day 90 of radiotherapy
2 secondary outcomes
PFS
Time frame: 3 years
OS
Time frame: 3 years
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 10 Apr 2019.
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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 Phase 3 study testing TPF neoadjuvant chemotherapy, Concurrent chemotherapy with cisplatin during radiotherapy and Concurrent nimotuzumab during radiotherapy in people with Nasopharyngeal Carcinoma, 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 5 inclusion and 5 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 10 Apr 2019. 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 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?
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?
Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) (time frame: From Day 1 to Day 90 of 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 10 Apr 2019.