Stage II, IIIPhase 2/3NCT03908372
Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
A Phase 2/3 study testing Docetaxel, Cisplatin and IMRT in people with Stage II, III and Nasopharyngeal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage II, III, Nasopharyngeal Squamous Cell Carcinoma, Induction Chemotheray
- What is being tested?
- Docetaxel, Cisplatin and IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2019to May 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathology confirmed nasopharyngeal squamous cell carcinoma.
- Aged 18 to 70 years old;
- Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
- KPS≥70;
- Have measurable lesions on CT/MRI before treatment;
- Treatment for the first time;
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- At least 6 months lifetime was expected;
- Adequate laboratory indexes, defined as follows: Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L < 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss;
- Can understand and sign the consent
- Have follow up condition
Who cannot join
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Previously treatment for cancer
- Pregnant or breeding woman, female without contraception
- Enrolling in other drug trials
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
- Without follow up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences
Beijin, 100021
Junlin yi, MD, 0086013661217998, yijunlin1969@163.com
About this study
Official title: A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
The purpose of this study is to optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Read the detailed description
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.
The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
CisplatinDrug
Also called DDP
Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy
IMRTRadiation
Also called intensity-modulated radiotherapy
IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy(IC)+IMRT | Experimental | Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: IMRT |
| Concurrent chemoradiotherapy(CCRT) | Active comparator | cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy Receives: Drug: Cisplatin; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival
Measured: 5 years
Secondary outcomes (3)
overall survival
Measured: 5 years
local-regional control
Measured: 5 years
complete response
efficacy will be measured by RECIST1.1
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Jun 2019
- Primary completionMay 2021 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stage II, IIIStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Lin Yi, MD, Chinese Academy of Medical Sciences
- Investigators
- Junlin Yi, professor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908372
- Sponsor's protocol ID
- NCC1950
- Status last verified
- Jan 2021
- First submitted
- 31 Mar 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20.
PubMed 29496056Liu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z.
PubMed 29323141Yao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6.
PubMed 28264724Xu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017.
PubMed 28243333
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03908372
- Acronym / sponsor ID
- NCC1950
- Conditions
- Stage II, III, Nasopharyngeal Squamous Cell Carcinoma, Induction Chemotheray, Concurrent Chemoradiotherapy, Reduce Treatment Intensity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 9 Apr 2019 (actual)
- 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 optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Detailed description
The data came from conventional studies showed that the distant metastases and toxicities associated with concurrent chemoradiotherapy were main problems for patients with clinical stage II and III nasopharyngeal carcinoma. However, inductive chemotherapy can decrease the likelihood of emergence of distant metastasis and reduce treatment related toxicities as previous studies showed.
The role of inductive chemotherapy in screening low-risk nasopharyngeal carcinoma for less treatment intensity is under-evaluated in the era of intensity-modulated radiotherapy (IMRT). we hope to find the optimized treatment strategies by reducing the intensity of treatment according to the treatment response of inductive chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy(IC)+IMRT | Experimental | Drug: Docetaxel, Drug: Cisplatin, Radiation: IMRTInduction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm |
| Concurrent chemoradiotherapy(CCRT) | Active comparator | Drug: Cisplatin, Radiation: IMRTcisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathology confirmed nasopharyngeal squamous cell carcinoma.
- Aged 18 to 70 years old;
- Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm;
- KPS≥70;
- Have measurable lesions on CT/MRI before treatment;
Key exclusion criteria (6 listed)
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
- Previously treatment for cancer
- Pregnant or breeding woman, female without contraception
- Enrolling in other drug trials
- Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
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 |
|---|---|---|
| DocetaxelAlso: TaxotereInduction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles | Drug | Induction chemotherapy(IC)+IMRT |
| CisplatinAlso: DDPInduction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy | Drug | Concurrent chemoradiotherapy(CCRT), Induction chemotherapy(IC)+IMRT |
| IMRTAlso: intensity-modulated radiotherapyIC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx. | Radiation | Concurrent chemoradiotherapy(CCRT), Induction chemotherapy(IC)+IMRT |
Primary outcome
progress free survival
Time frame: 5 years
3 secondary outcomes
overall survival
Time frame: 5 years
local-regional control
Time frame: 5 years
complete response
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 29496056Xu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20.
- Background: PubMed 29323141Liu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z.
- Background: PubMed 28264724Yao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6.
- Background: PubMed 28243333Xu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017.
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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.
Junlin Yi, professor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site 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 Docetaxel, Cisplatin and IMRT in people with Stage II, III and Nasopharyngeal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences 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 10 inclusion and 6 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 29 Jan 2021. 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 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 Junlin Yi, M.D (008601366121799, junlinyi@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival (time frame: 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 NCT03908372, which also lists 4 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 29 Jan 2021.