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| Name | Class |
|---|---|
| Taizhou Enze Medical Center Group | OTHER |
| Taizhou Cancer Hospital | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced dose group | Experimental | The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced dose | Radiation | The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Progression free survival (PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | The correlation between the radiotherapy dose with biomarkers such as peripheral blood lymphocyte and EBV-DNA. | up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haihua Yang, MD | Contact | 13819639006 | yhh93181@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haihua Yang, MD | Taizhou Enze Medical Center Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taizhou Central Hospital | Recruiting | Taizhou | Zhejiang | 317000 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D056687 | Off-Label Use |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011307 | Drug Prescriptions |
| D013812 | Therapeutics |
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| Conventional dose | Radiation | The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. |
|
| Chemotherapy | Drug | 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. |
|
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.
| 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. | 5 years |
| Incidence of treatment related acute complications | treatment-related adverse events will be assessed by NCI-CTC5.0 criteria and RTOG/EORTC criteria. | 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. | up to 5 years |
| Overall response rate | efficacy will be measured by PERCIST1.0 and RECIST1.1 criteria. | up to 5 years |
| Taizhou Hospital | Recruiting | Taizhou | Zhejiang | 317000 | China |
|
| Taizhou Cancer Hospital | Recruiting | Taizhou | Zhejiang | 317500 | China |
|
| Taizhou Enze Medical Center(Group) Enze Hospital | Recruiting | Taizhou | Zhejiang | 318050 | China |
|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |