Nasopharyngeal CarcinomaPhase 3NCT02633176
Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel in Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing Cetuximab, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 10 sites in China.
Trial summary
This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Cetuximab, Cisplatin and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesChina
- Study dates
- Jan 2015to Jan 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- Untreated metastatic nasopharyngeal carcinoma (stage ⅣC according to the 7th American Joint Committee on Cancer staging system and stage ⅣB according to the Chinese 2008 staging system for nasopharyngeal carcinoma)
- Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 6 months
- Absolute neutrophil count (ANC) >=1.5×10^9/L
Show all 15Show fewer
- Platelets >= 80×10^9/L
- Hemoglobin >= 90 g/l
- Bilirubin <= 1.5 × upper limit of normal (ULN)
- Aminopherases ( alanine transaminase and aspartate aminotransferase) <= 2.5 × ULN (without liver metastasis) or <= 5.0 × ULN (with liver metastasis)
- Creatinine <=ULN
- International normalized ratio (INR) of prothrombin time (PT) <= 1.5 × ULN
- The pregnancy tests of women of childbearing potential should be negative before treatment
- Women of childbearing potential and sexually active males must adopt efficient contraception methods while on treatment and for six months after the completion of the treatment
- Patients should understand and are willing to participate in the study. Inform consent form is supposed to obtained before treatment
Who cannot join
- Prior radiotherapy of target lesions
- Prior systemic chemotherapy and/or targeted therapy
- Brain metastasis
- Concurrent other malignancies
- Severe or active infectious disease requiring systemic antibiotics or antiviral, antifungal treatment
- Active tuberculosis
Show all 9Show fewer
- Severe cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction in the past 6 months, congestive heart failure with cardiac function grade Ⅲ to Ⅳ based on New York Heart Association cardiac functional grading, serious arrhythmia, or pericardial effusion
- Co-existing mental disease that would preclude full compliance with the study
- Females are pregnant or breast feeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610047
Jinyi Lang, MD, langjy610@163.com
Jinyi Lang, MD
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
Cheng Huang, MD, cheng671@sina.com
Cheng Huang, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhao Wang, MD, +86-20-87343694, wangzhao@sysucc.org.cn
He Huang, MD
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Mengping Zhang, MD, +86-20-87755766-8576, zhangmp1989@163.com
Sheng Ye, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yuan Zhu, MD, zhuyuan63@hotmail.com
Yuan Zhu, MD
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Jifeng Feng, MD, fjif@vip.sina.com
Jifeng Feng, MD
- Recruiting
Guangxi Cancer Hospital
Nanning, Guangxi, 530021
Chaoyong Liang, MD, lmlm1995@qq.com
Xiaohua Hu, MD
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, MD, xchu2009@hotmail.com
Xichun Hu, MD
- Recruiting
Union Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430022
Gang Wu, MD, xhzlwg@163.com
Gang Wu, MD
- Recruiting
Tongji Hospital,Tongji Medical College of Huazhong University of Science ＆ Technology
Wuhan, Hubei, 430030
Shiying Yu, MD, syyu@tjh.tjmu.edu.cn
Shiying Yu, MD
About this study
Official title: Phase Ⅲ Randomized Trial of Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel Induction Chemotherapy Followed by Concurrent Chemoradiation in Previously Untreated Patients Metastatic Nasopharyngeal Carcinoma
This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and prognostic factors for mNPC.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cetuximab, Cisplatin, Docetaxel, Capecitabine, Radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
400 mg/m^2 intravenously on day 1,then 250 mg/m^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m^2 intravenously every week concurrent with radiotherapy.
CisplatinDrug
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m^2 intravenously every week concurrent with radiotherapy.
DocetaxelDrug
Also called Taxotere
75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
CapecitabineDrug
Also called Xeloda
1000mg/m^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation.
RadiotherapyRadiation
60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| cisplatin and docetaxel | Active comparator | Induction chemotherapy: Patients receive cisplatin and docetaxel intravenously on day 1 repeated every 3 weeks for 6 cycles.
Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cisplatin 30mg/m^2 intravenously every week.
Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Capecitabine; Radiation: Radiotherapy |
| cetuximab, cisplatin, and docetaxel | Experimental | Induction chemotherapy: Patients receive cetuximab 400mg/m^2 intravenously over at least 120 minutes on day 1 followed by 250 mg/m^2 intravenously over at least 60 minutes every week. Cisplatin and docetaxel will be administered intravenously on day 2 repeated every 3 weeks for 6 cycles.
Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cetuximab 250mg/m^2 intravenously followed by cisplatin 30mg/m^2 intravenously every week.
Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. Receives: Drug: Cetuximab; Drug: Cisplatin; Drug: Docetaxel; Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Measured: From date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years
Secondary outcomes (4)
Event-free Survival
Event-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment without evidence of progression or relapse, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Measured: From date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment, or date of last assessment, whichever came first, assessed up to 5 years.
Disease-free Survival
Disease-free survival was defined as the time from date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Measured: From date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first, assessed up to 5 years.
Overall Survival
Overall survival was defined as the time from randomization until the date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
Measured: From date of randomization until the date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years.
Overall response rate
Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Overall response rate= complete response + partial response. Tumor measurements were performed using physical examination, computer tomography (CT) or Positron Emission Tomography-Computer Tomography (PET-CT) scans and Magnetic Resonance Imaging （MRI） scans, which were consist with baseline measurements methods.
Measured: every 6 weeks, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Southwest Oncology Group
- Responsible party
- Principal investigator, Tongyu Lin, Sun Yat-sen University
- Investigators
- Tongyu Lin, MD, Principal investigator, Sun Yat-Sen University Cancer CenterTaixiang Lu, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633176
- Sponsor's protocol ID
- CSWOG0103
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
Publications
Zhang M, Huang H, Li X, Huang Y, Chen C, Fang X, Wang Z, Guo C, Lam S, Fu X, Hong H, Tian Y, Lu T, Lin T. Long-Term Survival of Patients With Chemotherapy-Naive Metastatic Nasopharyngeal Carcinoma Receiving Cetuximab Plus Docetaxel and Cisplatin Regimen. Front Oncol. 2020 Jun 19;10:1011. doi: 10.3389/fonc.2020.01011. eCollection 2020.
PubMed 32637360
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Randomized Trial of Cisplatin Plus Docetaxel Versus Cetuximab, Cisplatin, and Docetaxel Induction Chemotherapy Followed by Concurrent Chemoradiation in Previously Untreated Patients Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02633176
- Acronym / sponsor ID
- CSWOG0103
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chinese Southwest Oncology Group
- Study start
- Jan 2015
- Primary completion
- Jan 2023 (estimated)
- First posted
- 17 Dec 2015 (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.
This is a Phase Ⅲ randomized, controlled, multi-center, trial comparing cisplatin plus docetaxel to cetuximab, cisplatin, and docetaxel induction chemotherapy followed by concurrent chemoradiation in previously untreated patients metastatic nasopharyngeal carcinoma (mNPC) to determine whether the addition of cetuximab to induction chemotherapy and chemoradiation could improve therapeutic efficacy in mNPC, and investigate predictive and prognostic factors for mNPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cisplatin and docetaxel | Active comparator | Drug: Cisplatin, Drug: Docetaxel, Drug: Capecitabine, Radiation: RadiotherapyInduction chemotherapy: Patients receive cisplatin and docetaxel intravenously on day 1 repeated every 3 weeks for 6 cycles. Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cisplatin 30mg/m^2 intravenously every week. Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. |
| cetuximab, cisplatin, and docetaxel | Experimental | Drug: Cetuximab, Drug: Cisplatin, Drug: Docetaxel, Drug: Capecitabine, Radiation: RadiotherapyInduction chemotherapy: Patients receive cetuximab 400mg/m^2 intravenously over at least 120 minutes on day 1 followed by 250 mg/m^2 intravenously over at least 60 minutes every week. Cisplatin and docetaxel will be administered intravenously on day 2 repeated every 3 weeks for 6 cycles. Concurrent chemoradiation: Patients who achieve complete response or partial response receive radiotherapy for primary and/or metastatic lesions with concurrent cetuximab 250mg/m^2 intravenously followed by cisplatin 30mg/m^2 intravenously every week. Maintenance treatment: Capecitabine will be given at a dose of 1000mg/m^2 orally twice a day starting on day 1 and continuing for days 1 to 14 of each 21 day cycle for at least 2 years or until progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- Untreated metastatic nasopharyngeal carcinoma (stage ⅣC according to the 7th American Joint Committee on Cancer staging system and stage ⅣB according to the Chinese 2008 staging system for nasopharyngeal carcinoma)
- Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 6 months
Key exclusion criteria (9 listed)
- Prior radiotherapy of target lesions
- Prior systemic chemotherapy and/or targeted therapy
- Brain metastasis
- Concurrent other malignancies
- Severe or active infectious disease requiring systemic antibiotics or antiviral, antifungal treatment
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 |
|---|---|---|
| CetuximabAlso: Erbitux400 mg/m^2 intravenously on day 1,then 250 mg/m^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m^2 intravenously every week concurrent with radiotherapy. | Drug | cetuximab, cisplatin, and docetaxel |
| Cisplatin75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m^2 intravenously every week concurrent with radiotherapy. | Drug | cetuximab, cisplatin, and docetaxel, cisplatin and docetaxel |
| DocetaxelAlso: Taxotere75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy. | Drug | cetuximab, cisplatin, and docetaxel, cisplatin and docetaxel |
| CapecitabineAlso: Xeloda1000mg/m^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation. | Drug | cetuximab, cisplatin, and docetaxel, cisplatin and docetaxel |
| Radiotherapy60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy. | Radiation | cetuximab, cisplatin, and docetaxel, cisplatin and docetaxel |
Primary outcome
Progression-free survival
Time frame: From date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years
Progression-free survival was defined as the time from date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first. All eligible and treated patients were included in the analysis.
4 secondary outcomes
Event-free Survival
Time frame: From date of randomization until the date of first documented progression, date of death from any cause, date of introduction of a new treatment, or date of last assessment, whichever came first, assessed up to 5 years.
Disease-free Survival
Time frame: From date of attainment a complete response until the date of first documented relapse, date of death from NPC or treatment-related toxicities, or date of last assessment, whichever came first, assessed up to 5 years.
Overall Survival
Time frame: From date of randomization until the date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years.
Overall response rate
Time frame: every 6 weeks, up to 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Derived from this study: PubMed 32637360Zhang M, Huang H, Li X, Huang Y, Chen C, Fang X, Wang Z, Guo C, Lam S, Fu X, Hong H, Tian Y, Lu T, Lin T. Long-Term Survival of Patients With Chemotherapy-Naive Metastatic Nasopharyngeal Carcinoma Receiving Cetuximab Plus Docetaxel and Cisplatin Regimen. Front Oncol. 2020 Jun 19;10:1011. doi: 10.3389/fonc.2020.01011. eCollection 2020.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Tongyu Lin, MD principal investigator
Sun Yat-Sen University Cancer Center
Taixiang Lu, MD principal investigator
Sun Yat-Sen University Cancer Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab, Cisplatin and Docetaxel in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 10 sites 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 15 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, MD (+86-20-87343363, huanghe@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of randomization until the date of first documented progression, date of death from any cause, or date of last assessment, whichever came first, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633176, which also lists 1 linked publication.
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 Dec 2015.