Nasopharyngeal CarcinomaPhase 3NCT02944708
Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing Conventional chemotherapy, Maintenance chemotherapy 1 and Maintenance chemotherapy 2 in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center at 14 sites in 3 countries.
Trial summary
The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. 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?
- Conventional chemotherapy, Maintenance chemotherapy 1 and Maintenance chemotherapy 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Oct 2015to Oct 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years
- Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III
- With distant metastasis
- With measurable lesions that can be detected by imaging studies
- Achieving PR (partial response) after 4 cycles of conventional chemotherapy
- Life expectancy ≥ 6 months
Show all 11Show fewer
- ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N > 2000/mm^3; PLT (platelet count) > 100,000/mm^3; total bilirubin < 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) < 1.5 ULN (upper limit of normal); SCr (serum creatinine) < 1.5mg/dl; CCR (creatinine clearance rate) > 60ml/min
- Willing to accept adequate contraception for women with childbearing potential
- Ability to understand character and individual consequences of the clinical trial
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
Who cannot join
- Received previous treatment for metastatic disease
- Pregnant or lactating women
- A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years
- Refusal of the patient to participate into the study
Trial locations and contacts
14 sites in 3 countries.
Lin Kong, MD contact
Jiyi Hu, MD contact
14 sites in 3 countries
China12 sites, 12 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Yan Sun, MD
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Ping Li, MD
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Jinshen Hong, MD, hjs703@126.com
- Recruiting
Jiangxi Province Tumor Hospital
Nanchang, Jiangxi, 330029
Xiaochang Gong, MD, gxcanddw@163.com
- Recruiting
Jiangxi Provincial Cancer Hospital
Nanchang, Jiangxi, 330029
Xiaochang Gong, MD, gxcanddw@163.com
- Recruiting
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Xiaodong Zhu, MD
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Heming Lu, MD
- Recruiting
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, 201315
Chaosu Hu, MD, hucsu62@yahoo.com
- Recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
Lin Kong, MD, lin.kong@sphic.org.cn
Jiyi Hu, MD, jiyi.hu@sphic.org.cn
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
Shengzi Wang, MD, shengziwang@fudan.edu.cn
- Recruiting
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030
Guoqing Hu, MD
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Qin Lin, MD, linqin05@163.com
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore, 119082
Boon Cher Goh, MD
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Jin-Ching Lin, MD, jclin@vghtc.gov.tw
About this study
Official title: A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
Read the detailed description
This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Conventional chemotherapy, Maintenance chemotherapy 1, Maintenance chemotherapy 2
- Keywords
- maintenance chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional chemotherapyDrug
Maintenance chemotherapy 1Drug
Maintenance chemotherapy 2Drug
| Study group | Role | What they receive |
|---|---|---|
| Conventional chemotherapy | Active comparator | Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred. Receives: Drug: Conventional chemotherapy |
| Maintenance chemotherapy 1 | Experimental | Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy. Receives: Drug: Conventional chemotherapy; Drug: Maintenance chemotherapy 1 |
| Maintenance chemotherapy 2 | Experimental | Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy. Receives: Drug: Conventional chemotherapy; Drug: Maintenance chemotherapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: From the time point the patients are included in the study, median of 3 years.
Secondary outcomes (2)
Overall survival
Measured: From the time point the patients are included in the study, median of 3 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: From the time point the patients are included in the study, median of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (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.
- 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
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Eye & ENT Hospital of Fudan University, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Taichung Veterans General Hospital, First Affiliated Hospital of Fujian Medical University, Cancer Hospital of Guangxi Medical University, National Cancer Centre, Singapore, West China Hospital, Peking University Cancer Hospital & Institute, Tongji Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Principal investigator, Lin Kong, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade J Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944708
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2015-04
- Status last verified
- Oct 2016
- First submitted
- 24 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02944708
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2015-04
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- maintenance chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Collaborators
- Fudan University, Eye & ENT Hospital of Fudan University, The First Affiliated Hospital of Xiamen University, Jiangxi Provincial Cancer Hospital, Taichung Veterans General Hospital, First Affiliated Hospital of Fujian Medical University, Cancer Hospital of Guangxi Medical University, National Cancer Centre, Singapore, West China Hospital, Peking University Cancer Hospital & Institute, Tongji Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Oct 2016 (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 purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
Detailed description
This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional chemotherapy | Active comparator | Drug: Conventional chemotherapyPatients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred. |
| Maintenance chemotherapy 1 | Experimental | Drug: Conventional chemotherapy, Drug: Maintenance chemotherapy 1Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy. |
| Maintenance chemotherapy 2 | Experimental | Drug: Conventional chemotherapy, Drug: Maintenance chemotherapy 2Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 and ≤ 70 years
- Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III
- With distant metastasis
- With measurable lesions that can be detected by imaging studies
- Achieving PR (partial response) after 4 cycles of conventional chemotherapy
Key exclusion criteria (4 listed)
- Received previous treatment for metastatic disease
- Pregnant or lactating women
- A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years
- Refusal of the patient to participate into the study
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 |
|---|---|---|
| Conventional chemotherapy | Drug | Conventional chemotherapy, Maintenance chemotherapy 1, Maintenance chemotherapy 2 |
| Maintenance chemotherapy 1 | Drug | Maintenance chemotherapy 1 |
| Maintenance chemotherapy 2 | Drug | Maintenance chemotherapy 2 |
Primary outcome
Progression-free survival
Time frame: From the time point the patients are included in the study, median of 3 years.
2 secondary outcomes
Overall survival
Time frame: From the time point the patients are included in the study, median of 3 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: From the time point the patients are included in the study, median of 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Lin Kong, MD contact
Jiyi Hu, MD contact
Jiade J Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional chemotherapy, Maintenance chemotherapy 1 and Maintenance chemotherapy 2 in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center at 14 sites in 3 countries.
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 11 inclusion and 4 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China, Singapore, Taiwan. 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 Lin Kong, MD (lin.kong@sphic.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 the time point the patients are included in the study, median of 3 years.). 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 27 Oct 2016.