18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: Reduced dose
* Radiation: Conventional dose
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced dose group<br>The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. | Radiation: Reduced dose<br>* The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.<br>Drug: Chemotherapy<br>* 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.<br>|
| Active Comparator: Conventional dose group<br>The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. | Radiation: Conventional dose<br>* The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.<br>Drug: Chemotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |