18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reduced dose, Conventional dose, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Overview
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).
Interventions
- Radiation Reduced dose
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions. - Radiation Conventional dose
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions. - Drug Chemotherapy
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.
Primary outcome measures
- Local-regional recurrence free survival (LRFS) [Time frame: 5 years]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Taizhou Central Hospital — Taizhou
- Taizhou Hospital — Taizhou
- Taizhou Cancer Hospital — Taizhou
- Taizhou Enze Medical Center(Group) Enze Hospital — Taizhou
Identifiers
NCT: NCT04813705 · PRR-202103