Nasopharyngeal CarcinomaPhase 2REPLACENCT01271439
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
A Phase 2 study testing Cetuximab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2012
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of nasopharyngeal carcinoma
- Range from 18～69 years old
- T3-4，N0-2，M0 (AJCC 2009)
- KPS ≥ 80
- Nonmetastatic diseases
- WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN
- 0Serum creatinine < 1.5×ULN
Who cannot join
- Distance metastases
- Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
- Second malignancy within 5 years
- Precious therapy with an investigational agent
- Uncontrolled seizure disorder or other serious neurologic disease
- ≥ Grade Ш allergic reaction to any drug including in this study
Show all 13Show fewer
- Clinically significant cardiac or respiratory disease
- Creatinine clearance < 30ml/min
- Drug or alcohol addition
- Do not have full capacity for civil acts
- Severe complication, active infection
- Concurrent immunotherapy or hormone therapy for other diseases
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cetuximab
- 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 C225
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| cetuximab | Experimental | Not described Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 Month Complete Response Rate + Partial Response Rate
According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
Measured: 3 Months
Secondary outcomes (10)
One-year locoregional control rate
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Measured: 1 year
Three-year locoregional control rate
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Measured: 3 years
One-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
Measured: 1 year
Three-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
Measured: 3 years
One-year overall survival rate
overall survival rate: from the time when finish treatment to death of any cause.
Measured: 1 year
Three-year overall survival rate
overall survival rate: from the time when finish treatment to death of any cause.
Measured: 3 years
The relationship between 3 years overall survival rate and expression of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Measured: 3 years
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life
collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.
Measured: 3 years
The relationship between 3 years overall survival rate and amplification of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Measured: 3 years
The relationship between 3 years overall survival rate and mutation of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
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 posted6 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionDec 2012
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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Wenzhou Medical University, First Affiliated Hospital of Guangxi Medical University, Xijing Hospital, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan University, Hubei Cancer Hospital, Tongji University, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen People's Hospital, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- Chong Zhao, Principal investigator, Sun Yat-sen UniversityYunfeng Zhou, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271439
- Sponsor's protocol ID
- REPLACE
- Acronym
- REPLACE
- Status last verified
- Nov 2011
- First submitted
- 5 Jan 2011
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01271439
- Acronym / sponsor ID
- REPLACE / REPLACE
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Wenzhou Medical University, First Affiliated Hospital of Guangxi Medical University, Xijing Hospital, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan University, Hubei Cancer Hospital, Tongji University, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen People's Hospital, First People's Hospital of Foshan
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Jan 2011 (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 an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab | Experimental | Drug: Cetuximab |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologic diagnosis of nasopharyngeal carcinoma
- Range from 18～69 years old
- T3-4，N0-2，M0 (AJCC 2009)
- KPS ≥ 80
- Nonmetastatic diseases
Key exclusion criteria (13 listed)
- Distance metastases
- Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
- Second malignancy within 5 years
- Precious therapy with an investigational agent
- Uncontrolled seizure disorder or other serious neurologic disease
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: C225400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy | Drug | cetuximab |
Primary outcome
3 Month Complete Response Rate + Partial Response Rate
Time frame: 3 Months
According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
10 secondary outcomes
One-year locoregional control rate
Time frame: 1 year
Three-year locoregional control rate
Time frame: 3 years
One-year disease free survival rate
Time frame: 1 year
Three-year disease free survival rate
Time frame: 3 years
One-year overall survival rate
Time frame: 1 year
Three-year overall survival rate
Time frame: 3 years
The relationship between 3 years overall survival rate and expression of EGFR
Time frame: 3 years
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life
Time frame: 3 years
The relationship between 3 years overall survival rate and amplification of EGFR
Time frame: 3 years
The relationship between 3 years overall survival rate and mutation of EGFR
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 13 Aug 2013.
- Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
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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.
Chong Zhao principal investigator
Sun Yat-sen University
Yunfeng Zhou principal investigator
Zhongnan 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 Cetuximab in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 8 inclusion and 13 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 13 Aug 2013. 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?
3 Month Complete Response Rate + Partial Response Rate (time frame: 3 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 13 Aug 2013.