Nasopharyngeal CarcinomaCTVp1-NPCNCT05994170
Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma
A study testing Reduction CTVp1 and Non-reduction CTVp1 in people with Nasopharyngeal Carcinoma and Intensity-Modulated Radiotherapy, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Intensity-Modulated Radiotherapy
- What is being tested?
- Reduction CTVp1 and Non-reduction CTVp1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2023to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
- newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
- nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
- planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
- no previous treatment for cancer；
- a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability);
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- between 18 and 70 years old;
- adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- receipt of treatment with palliative intent;
- receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
- had disease progress after neoadjuvant chemotherapy in local advantage NPC
- presence of distant metastasis;
- Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
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- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
- lactation or pregnancy;
- Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Guiqiong Xu, +8613528109888, donna_shee@163.com
Yu-long Xie, MD, +8615625031643, xieyl1@sysucc.org.cn
About this study
Official title: Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)
To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
Read the detailed description
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.
- Being tested
- Reduction CTVp1, Non-reduction CTVp1
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction CTVp1Radiation
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
Non-reduction CTVp1Radiation
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)
| Study group | Role | What they receive |
|---|---|---|
| Reduction CTVp1 | Experimental | CTVp1=GTVp+5mm Receives: Radiation: Reduction CTVp1 |
| Non-reduction CTVp1 | Placebo comparator | CTVp1=GTVp+5mm+whole nasopharynx Receives: Radiation: Non-reduction CTVp1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Relapse-free Survival(LRFS)
the time from randomization to documented local recurrence or death from any cause
Measured: 3 years
Incidence of hearing impairment worse than graded 2
audiometry and symptoms graded according to the CTCAE (version 5.0).
Measured: 3 years
Secondary outcomes (9)
Overall survival (OS)
the time from randomization to documented death from any cause
Measured: 3 years
Regional Relapse-free Survival(RRFS)
the time from randomization to documented regional recurrence or death from any cause
Measured: 3 years
Distant metastasis-free survival (DMFS)
calculated from randomization to documented distant metastasis or death
Measured: 3 years
Acute toxicities
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
Measured: 3 months
Late toxicities
3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
Measured: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Measured: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Measured: 3 years
radiation-induced otitis media with effusion (OME)
Evaluated by tympanometry
Measured: 3 years
V60Gy
Volume that received at least 60Gy
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 posted16 Aug 2023
- Study start4 Aug 2023
- Primary completion4 Aug 2026 (estimated)
- Study completion1 Sep 2029 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 454 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, Gui-Qiong Xu, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Gui-qiong Xu, Principal investigator, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994170
- Sponsor's protocol ID
- ZSCPH-002
- Acronym
- CTVp1-NPC
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)
- ClinicalTrials.gov ID
- NCT05994170
- Acronym / sponsor ID
- CTVp1-NPC / ZSCPH-002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 454 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 4 Aug 2026 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 16 Aug 2023 (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.
To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
Detailed description
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduction CTVp1 | Experimental | Radiation: Reduction CTVp1CTVp1=GTVp+5mm |
| Non-reduction CTVp1 | Placebo comparator | Radiation: Non-reduction CTVp1CTVp1=GTVp+5mm+whole nasopharynx |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III);
- newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system
- nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically.
- planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0：No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies，node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy )
- no previous treatment for cancer；
Key exclusion criteria (9 listed)
- receipt of treatment with palliative intent;
- receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx;
- had disease progress after neoadjuvant chemotherapy in local advantage NPC
- presence of distant metastasis;
- Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
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 |
|---|---|---|
| Reduction CTVp1High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm) | Radiation | Reduction CTVp1 |
| Non-reduction CTVp1High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx) | Radiation | Non-reduction CTVp1 |
Primary outcome
Local Relapse-free Survival(LRFS)
Time frame: 3 years
the time from randomization to documented local recurrence or death from any cause
Incidence of hearing impairment worse than graded 2
Time frame: 3 years
audiometry and symptoms graded according to the CTCAE (version 5.0).
9 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Regional Relapse-free Survival(RRFS)
Time frame: 3 years
Distant metastasis-free survival (DMFS)
Time frame: 3 years
Acute toxicities
Time frame: 3 months
Late toxicities
Time frame: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Time frame: 3 years
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Time frame: 3 years
radiation-induced otitis media with effusion (OME)
Time frame: 3 years
V60Gy
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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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.
Gui-qiong Xu principal investigator
Zhongshan People's Hospital, Guangdong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction CTVp1 and Non-reduction CTVp1 in people with Nasopharyngeal Carcinoma and Intensity-Modulated Radiotherapy, run by Zhongshan People's Hospital, Guangdong, China 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Aug 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gui-qiong Xu (+8613528109888, donna_shee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Relapse-free Survival(LRFS) (time frame: 3 years). The study lists 2 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 16 Aug 2023.