Nasopharyngeal CarcinomaPhase 2/3NPCNCT01854203
Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC
A Phase 2/3 study testing Inductive chemotherapy + concurrent cisplatin and IMRT and Inductive chemotherapy + IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Inductive chemotherapy + concurrent cisplatin and IMRT and Inductive chemotherapy + IMRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2013to Dec 2016
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
- A Karnofsky performance status of at least 80;
- Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
- Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: a creatinine clearance rate of at least 60 mL/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- WHO Type keratinizing squamous cell carcinoma.
- Age >65 years or <18 years.
- Distant metastasis,
- Treatment with palliative intent.
- Pregnancy or lactation.
- a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
- history of renal disease, unstable cardiac disease requiring treatment.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Center,Sun Yat-sen University
Guangzhou, Guangdong, 510060
Jian-jun Li, MD, +862087343381, lijj@sysucc.org.cn
- Not yet recruiting
State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University
Guangzhou, 510060
Jian-jun Li, M.D.
Li-zhi Liu, M.D.
About this study
Official title: Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
Read the detailed description
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Inductive chemotherapy + concurrent cisplatin and IMRT, Inductive chemotherapy + IMRT
- Keywords
- Cisplatin, neoadjuvant chemotherapy, intensity-modulated radiation therapy, 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.
Inductive chemotherapy + concurrent cisplatin and IMRTDrug
Also called Gemcitabine and cisplatin
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
Inductive chemotherapy + IMRTDrug
Also called Gemcitabine and cisplatin
Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
| Study group | Role | What they receive |
|---|---|---|
| IInductive chemotherapy + concurrent cisplatin and IMRT | Experimental | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy. Receives: Drug: Inductive chemotherapy + concurrent cisplatin and IMRT |
| Inductive chemotherapy + IMRT | Experimental | Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT. Receives: Drug: Inductive chemotherapy + IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is calculated from randomization to death from any cause.
Measured: 3-year
Failure-free survival
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Measured: 3-year
Locoregional failure-free survival
the latency to the first local failure
Measured: 3-year
Distant failure-free survival
The latency to the first remote failure
Measured: 3-year
Secondary outcomes (1)
Difference in the complete response rates between the two treatment arms
Measured: 12 weeks after the completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Li, Sun Yat-sen University
- Investigators
- yong Su, M.D., Study director, Sun Yat-Sen University Cancer CenterJanjun Li, M.D., Principal investigator, Sun Yat-Sen University Cancer CenterLizhi Liu, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854203
- Sponsor's protocol ID
- ChiECRCT-2013003
- Acronym
- NPC
- Status last verified
- Jul 2013
- First submitted
- 10 May 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01854203
- Acronym / sponsor ID
- NPC / ChiECRCT-2013003
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Cisplatin, neoadjuvant chemotherapy, intensity-modulated radiation therapy, concurrent chemoradiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 May 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.
Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.
Detailed description
The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IInductive chemotherapy + concurrent cisplatin and IMRT | Experimental | Drug: Inductive chemotherapy + concurrent cisplatin and IMRTPatients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy. |
| Inductive chemotherapy + IMRT | Experimental | Drug: Inductive chemotherapy + IMRTPatients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
- A Karnofsky performance status of at least 80;
- Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
- Adequate marrow: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
Key exclusion criteria (7 listed)
- WHO Type keratinizing squamous cell carcinoma.
- Age >65 years or <18 years.
- Distant metastasis,
- Treatment with palliative intent.
- Pregnancy or lactation.
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 |
|---|---|---|
| Inductive chemotherapy + concurrent cisplatin and IMRTAlso: Gemcitabine and cisplatinPatients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy. | Drug | IInductive chemotherapy + concurrent cisplatin and IMRT |
| Inductive chemotherapy + IMRTAlso: Gemcitabine and cisplatinPatients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT. | Drug | Inductive chemotherapy + IMRT |
Primary outcome
Overall survival
Time frame: 3-year
Overall survival is calculated from randomization to death from any cause.
Failure-free survival
Time frame: 3-year
Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Locoregional failure-free survival
Time frame: 3-year
the latency to the first local failure
Distant failure-free survival
Time frame: 3-year
The latency to the first remote failure
1 secondary outcome
Difference in the complete response rates between the two treatment arms
Time frame: 12 weeks after the completion of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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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.
yong Su, M.D. study director
Sun Yat-Sen University Cancer Center
Janjun Li, M.D. principal investigator
Sun Yat-Sen University Cancer Center
Lizhi Liu, M.D. principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inductive chemotherapy + concurrent cisplatin and IMRT and Inductive chemotherapy + IMRT in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 2 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 7 inclusion and 7 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined 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.
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 Janjun Li, M.D. (+86+13829745245, lijj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3-year). The study lists 4 primary outcomes in all. 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 30 Jul 2013.