Nasopharyngeal CarcinomaPhase 2NCT04813705
18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
A Phase 2 study testing Reduced dose, Conventional dose and Chemotherapy in people with Nasopharyngeal Carcinoma, run by Taizhou Hospital at 4 sites in China.
Trial summary
The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Reduced dose, Conventional dose and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2022to 30 Jun 2029
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathology confirmed nasopharyngeal squamous cell carcinoma.
- Stage I-IVA（8thAJCC/UICC staging system).
- Aged 18-80 years.
- KPS≥70.
- Have measurable lesions on 18F-FDG PET/CT before treatment.
- HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.
Show all 10Show fewer
- ALT,AST<2.5 fold of ULN；TBIL<2.0×ULN.
- CCR≥60ml/min or Cr<1.5×ULN.
- Signed informed consent.
- Have follow up condition.
Who cannot join
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
- Age <18 or >80years.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- With sever infection and internal disease.
- Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Taizhou Central Hospital
Taizhou, Zhejiang, 317000
Shenpeng Ying, 13957608158
Shenpeng Ying
- Recruiting
Taizhou Hospital
Taizhou, Zhejiang, 317000
Haihua Yang, MD, +86 13819639006, yhh93181@hotmail.com
Weijun Ding
- Recruiting
Taizhou Cancer Hospital
Taizhou, Zhejiang, 317500
Guangxian You, MD, 13676668511
Guangxian You
- Recruiting
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, 318050
Haihua Yang, MD, +86 13819639006, yhh93181@hotmail.com
Haihua Yang, MD
About this study
Official title: A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
The purpose of this study is to explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.
Read the detailed description
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Reduced dose, Conventional dose, 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.
Reduced doseRadiation
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Conventional doseRadiation
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
ChemotherapyDrug
The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.
| Study group | Role | What they receive |
|---|---|---|
| Reduced dose group | Experimental | The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. Receives: Radiation: Reduced dose; Drug: Chemotherapy |
| Conventional dose group | Active comparator | The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. Receives: Radiation: Conventional dose; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-regional recurrence free survival (LRFS)
The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.
Measured: 5 years
Secondary outcomes (6)
Overall survival (OS)
The OS was defined as the duration from the date of of initiation of treatment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 5 years
Progression free survival (PFS)
Progress-free survival is calculated from the date of initiation of treatment to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
Measured: 5 years
Distant metastasis-free survival (DMFS)
The DMFS is evaluated and calculated from the date of initiation treatment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 5 years
Incidence of treatment related acute complications
treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.
Measured: up to 3 months
Incidence of treatment related late complications
treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria.
Measured: up to 5 years
Overall response rate
efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Taizhou Cancer Hospital
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- Haihua Yang, MD, Principal investigator, Taizhou Enze Medical Center Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813705
- Sponsor's protocol ID
- PRR-202103
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04813705
- Acronym / sponsor ID
- PRR-202103
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Collaborators
- Taizhou Enze Medical Center Group, Taizhou Cancer Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 24 Mar 2021 (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 explore whether 18F-FDG PET/CT guided reduced-dose radiotherapy would maintain survival outcomes in nasopharyngeal carcinoma (NPC) patients.
Detailed description
Enrolled patients with complete metabolic response (CMR) and more than 70% partial metabolic response (PMR) according to PERCIST criteria at the 25th fraction will receive intensity modulated radiation therapy (IMRT) of reduced-dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions), for those who with ≤70% PMR will receive conventional dose (prescribed dose, 70Gy, 2.12 Gy per fractions, 33 fractions).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced dose group | Experimental | Radiation: Reduced dose, Drug: ChemotherapyThe patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. |
| Conventional dose group | Active comparator | Radiation: Conventional dose, Drug: ChemotherapyThe patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathology confirmed nasopharyngeal squamous cell carcinoma.
- Stage I-IVA（8thAJCC/UICC staging system).
- Aged 18-80 years.
- KPS≥70.
- Have measurable lesions on 18F-FDG PET/CT before treatment.
Key exclusion criteria (7 listed)
- Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
- Age <18 or >80years.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
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 |
|---|---|---|
| Reduced doseThe patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. | Radiation | Reduced dose group |
| Conventional doseThe patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. | Radiation | Conventional dose group |
| ChemotherapyThe patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT. | Drug | Conventional dose group, Reduced dose group |
Primary outcome
Local-regional recurrence free survival (LRFS)
Time frame: 5 years
The LRFS is evaluated and calculated from the date of initiation of treatment until the day of first locoregional relapse or until the date of the last follow-up visit.
6 secondary outcomes
Overall survival (OS)
Time frame: 5 years
Progression free survival (PFS)
Time frame: 5 years
Distant metastasis-free survival (DMFS)
Time frame: 5 years
Incidence of treatment related acute complications
Time frame: up to 3 months
Incidence of treatment related late complications
Time frame: up to 5 years
Overall response rate
Time frame: up to 5 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 21 Feb 2023.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent 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
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
Haihua Yang, MD principal investigator
Taizhou Enze Medical Center Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduced dose, Conventional dose and Chemotherapy in people with Nasopharyngeal Carcinoma, run by Taizhou Hospital at 4 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 10 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: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
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 Haihua Yang, MD (13819639006, yhh93181@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-regional recurrence free survival (LRFS) (time frame: 5 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 21 Feb 2023.