Nasopharyngeal CarcinomaPhase 2NCT02610556
Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With IMRT in High Risk Nasopharyngeal Carcinoma
A Phase 2 study testing Cisplatin 2, Docetaxel and Cisplatin 1 in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma. 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?
- Cisplatin 2, Docetaxel and Cisplatin 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
- Tumor staged as T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system).
- Pretreatment EBV DNA ≥ 1500 copies/mL.
- Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
- Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
- Patients must give written informed consent.
Who cannot join
- Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
- Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fang-Yun Xie, M.D., +86-020-87342618, xiefy@sysucc.org.cn
Pu-Yun OuYang, M.D., +86-020-87342618, ouyangpy@sysucc.org.cn
About this study
Official title: Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial
The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.
Read the detailed description
Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cisplatin 2, Docetaxel, Cisplatin 1, Intensity-modulated radiotherapy
- Keywords
- NPC, concurrent chemotherapy, docetaxel, cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin 2Drug
Also called DDP
Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles
DocetaxelDrug
Also called T
Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles
Cisplatin 1Drug
Also called P
Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles
Intensity-modulated radiotherapyRadiation
Also called IMRT
Intensity-modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| TP plus IMRT | Experimental | Concurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy Receives: Drug: Docetaxel; Drug: Cisplatin 1; Radiation: Intensity-modulated radiotherapy |
| DDP plus IMRT | Active comparator | Concurrent chemotherapy: DDP - Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy Receives: Drug: Cisplatin 2; Radiation: Intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: two year
Secondary outcomes (4)
failure-free survival
Measured: two year
distant metastasis-free survival
Measured: two year
locoregional relapse-free survival
Measured: two year
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
- Investigators
- Fang-Yun Xie, M.D., Principal investigator, Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610556
- Sponsor's protocol ID
- 2015-FXY-071-Dept. of RT
- Status last verified
- May 2016
- First submitted
- 13 Nov 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang LN, Gao YH, Lan XW, Tang J, OuYang PY, Xie FY. Effect of taxanes-based induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A large scale propensity-matched study. Oral Oncol. 2015 Oct;51(10):950-6. doi: 10.1016/j.oraloncology.2015.07.004. Epub 2015 Jul 21.
PubMed 26209065Xie FY, Zou GR, Hu WH, Qi SN, Peng M, Li JS. [Induction chemotherapy with docetaxel plus cisplatin (TP regimen) followed by concurrent chemoradiotherapy with TP regimen versus cisplatin in treating locally advanced nasopharyngeal carcinoma]. Ai Zheng. 2009 Mar;28(3):279-85. Chinese.
PubMed 19619443Tishler RB, Schiff PB, Geard CR, Hall EJ. Taxol: a novel radiation sensitizer. Int J Radiat Oncol Biol Phys. 1992;22(3):613-7. doi: 10.1016/0360-3016(92)90888-o.
PubMed 1346533Tishler RB, Geard CR, Hall EJ, Schiff PB. Taxol sensitizes human astrocytoma cells to radiation. Cancer Res. 1992 Jun 15;52(12):3495-7.
PubMed 1350755Komatsu M, Shiono O, Taguchi T, Sakuma Y, Nishimura G, Sano D, Sakuma N, Yabuki K, Arai Y, Takahashi M, Isitoya J, Oridate N. Concurrent chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with locally advanced squamous cell carcinoma of the head and neck. Jpn J Clin Oncol. 2014 May;44(5):416-21. doi: 10.1093/jjco/hyu026. Epub 2014 Mar 30.
PubMed 24688084Inohara H, Takenaka Y, Yoshii T, Nakahara S, Yamamoto Y, Tomiyama Y, Seo Y, Isohashi F, Suzuki O, Yoshioka Y, Sumida I, Ogawa K. Phase 2 study of docetaxel, cisplatin, and concurrent radiation for technically resectable stage III-IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):934-41. doi: 10.1016/j.ijrobp.2014.12.032.
PubMed 25832686Higuchi K, Komori S, Tanabe S, Katada C, Azuma M, Ishiyama H, Sasaki T, Ishido K, Katada N, Hayakawa K, Koizumi W; Kitasato Digestive Disease and Oncology Group. Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):872-9. doi: 10.1016/j.ijrobp.2014.03.030. Epub 2014 May 24.
PubMed 24867539Chen X, Hong Y, Feng J, Ye J, Zheng P, Guan X, You X, Song H. Concurrent chemoradiotherapy comparison of taxanes and platinum versus 5-fluorouracil and platinum in nasopharyngeal carcinoma treatment. Chin Med J (Engl). 2014;127(1):142-9.
PubMed 24384440Baykara M, Buyukberber S, Ozturk B, Coskun U, Kaplan MA, Unsal DK, Dane F, Demirci U, Bora H, Benekli M; Anatolian Society of Medical Oncology. Efficacy and safety of concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced nasopharyngeal cancers. Tumori. 2013 Jul-Aug;99(4):469-73. doi: 10.1177/030089161309900405.
PubMed 24326834Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
PubMed 25957714
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Docetaxel Plus Cisplatin or Cisplatin Alone With Intensity-modulated Radiotherapy in High Risk Locregionally Advanced Nasopharyngeal Carcinoma: a Phase 2 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02610556
- Acronym / sponsor ID
- 2015-FXY-071-Dept. of RT
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- NPC, concurrent chemotherapy, docetaxel, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 20 Nov 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.
The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.
Detailed description
Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy of docetaxel plus cisplatin or cisplatin alone. IMRT is delivered with a total dose of 68 Gy or higher in 33 fractions to the primary tumor. Concurrent chemotherapy in the experimental arm consists of docetaxel 60 mg/m², D1 and cisplatin 25 mg/m², D1-3 every 3 weeks for 3 cycles. Concurrent chemotherapy in the control arm consists of cisplatin 100 mg/m², D1 every 3 weeks for 3 cycles.The primary endpoint is overall survival (OS), defined as time from randomization to the day of death from any cause. Secondary end points include failure-free survival (FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and the incidence of grade 3 or higher acute toxicities. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TP plus IMRT | Experimental | Drug: Docetaxel, Drug: Cisplatin 1, Radiation: Intensity-modulated radiotherapyConcurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy |
| DDP plus IMRT | Active comparator | Drug: Cisplatin 2, Radiation: Intensity-modulated radiotherapyConcurrent chemotherapy: DDP - Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
- Tumor staged as T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system).
- Pretreatment EBV DNA ≥ 1500 copies/mL.
- Karnofsky scale (KPS) ≥ 70.
- Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
Key exclusion criteria (5 listed)
- Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
- Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
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 |
|---|---|---|
| Cisplatin 2Also: DDPCisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles | Drug | DDP plus IMRT |
| DocetaxelAlso: TDocetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles | Drug | TP plus IMRT |
| Cisplatin 1Also: PCisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles | Drug | TP plus IMRT |
| Intensity-modulated radiotherapyAlso: IMRTIntensity-modulated radiotherapy | Radiation | DDP plus IMRT, TP plus IMRT |
Primary outcome
overall survival
Time frame: two year
4 secondary outcomes
failure-free survival
Time frame: two year
distant metastasis-free survival
Time frame: two year
locoregional relapse-free survival
Time frame: two year
Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
Time frame: up to two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Background: PubMed 26209065Zhang LN, Gao YH, Lan XW, Tang J, OuYang PY, Xie FY. Effect of taxanes-based induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A large scale propensity-matched study. Oral Oncol. 2015 Oct;51(10):950-6. doi: 10.1016/j.oraloncology.2015.07.004. Epub 2015 Jul 21.
- Background: PubMed 19619443Xie FY, Zou GR, Hu WH, Qi SN, Peng M, Li JS. [Induction chemotherapy with docetaxel plus cisplatin (TP regimen) followed by concurrent chemoradiotherapy with TP regimen versus cisplatin in treating locally advanced nasopharyngeal carcinoma]. Ai Zheng. 2009 Mar;28(3):279-85. Chinese.
- Background: PubMed 1346533Tishler RB, Schiff PB, Geard CR, Hall EJ. Taxol: a novel radiation sensitizer. Int J Radiat Oncol Biol Phys. 1992;22(3):613-7. doi: 10.1016/0360-3016(92)90888-o.
- Background: PubMed 1350755Tishler RB, Geard CR, Hall EJ, Schiff PB. Taxol sensitizes human astrocytoma cells to radiation. Cancer Res. 1992 Jun 15;52(12):3495-7.
- Background: PubMed 24688084Komatsu M, Shiono O, Taguchi T, Sakuma Y, Nishimura G, Sano D, Sakuma N, Yabuki K, Arai Y, Takahashi M, Isitoya J, Oridate N. Concurrent chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with locally advanced squamous cell carcinoma of the head and neck. Jpn J Clin Oncol. 2014 May;44(5):416-21. doi: 10.1093/jjco/hyu026. Epub 2014 Mar 30.
- Background: PubMed 25832686Inohara H, Takenaka Y, Yoshii T, Nakahara S, Yamamoto Y, Tomiyama Y, Seo Y, Isohashi F, Suzuki O, Yoshioka Y, Sumida I, Ogawa K. Phase 2 study of docetaxel, cisplatin, and concurrent radiation for technically resectable stage III-IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):934-41. doi: 10.1016/j.ijrobp.2014.12.032.
- Background: PubMed 24867539Higuchi K, Komori S, Tanabe S, Katada C, Azuma M, Ishiyama H, Sasaki T, Ishido K, Katada N, Hayakawa K, Koizumi W; Kitasato Digestive Disease and Oncology Group. Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):872-9. doi: 10.1016/j.ijrobp.2014.03.030. Epub 2014 May 24.
- Background: PubMed 24384440Chen X, Hong Y, Feng J, Ye J, Zheng P, Guan X, You X, Song H. Concurrent chemoradiotherapy comparison of taxanes and platinum versus 5-fluorouracil and platinum in nasopharyngeal carcinoma treatment. Chin Med J (Engl). 2014;127(1):142-9.
- Background: PubMed 24326834Baykara M, Buyukberber S, Ozturk B, Coskun U, Kaplan MA, Unsal DK, Dane F, Demirci U, Bora H, Benekli M; Anatolian Society of Medical Oncology. Efficacy and safety of concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced nasopharyngeal cancers. Tumori. 2013 Jul-Aug;99(4):469-73. doi: 10.1177/030089161309900405.
- Background: PubMed 25957714Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.
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
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 2
Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 2
Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC)
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.
Fang-Yun Xie, M.D. principal investigator
Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China
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 Cisplatin 2, Docetaxel and Cisplatin 1 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 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: status not confirmed, as of the sponsor's last update on 26 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang-Yun Xie, M.D. (+86-020-87342618, xiefy@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: two year). 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 NCT02610556, which also lists 10 linked publications.
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 26 May 2016; AzTrials last refreshed its copy on 3 Nov 2026.