Clinical trial NCT04813705: 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Official title: A Multicenter Phase II Study of 18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
Collaborators: name: Taizhou Enze Medical Center Group
name: Taizhou Cancer Hospital
First posted: 2021-03-24
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

1. Pathology confirmed nasopharyngeal squamous cell carcinoma.
2. Stage I-IVA（8thAJCC/UICC staging system).
3. Aged 18-80 years.
4. KPS≥70.
5. Have measurable lesions on 18F-FDG PET/CT before treatment.
6. HGB≥90 g/L，ANC≥1.5×109 /L，PLT≥80×109 /L.
7. ALT,AST\<2.5 fold of ULN；TBIL\<2.0×ULN.
8. CCR≥60ml/min or Cr\<1.5×ULN.
9. Signed informed consent.
10. Have follow up condition.

Exclusion Criteria:

1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ).
2. Age \<18 or \>80years.
3. Pregnancy or lactation.
4. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. With sever infection and internal disease.
7. Major organ dysfunction, such as decompensated cardiopulmonary, kidney, liver failure, cannot tolerate surgical treatment.

Primary outcomes:
measure: Local-regional recurrence free survival (LRFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Distant metastasis-free survival (DMFS)
timeFrame: 5 years
measure: Incidence of treatment related acute complications
timeFrame: up to 3 months
measure: Incidence of treatment related late complications
timeFrame: up to 5 years
measure: Overall response rate
timeFrame: up to 5 years
Other outcomes:
measure: Biomarkers
timeFrame: up to 5 years
Locations:
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Cancer Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Enze Medical Center(Group) Enze Hospital
state: Zhejiang
Study officials:
affiliation: Taizhou Enze Medical Center Group
name: Haihua Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: