18F-FDG PET/CT Guided Reduced-dose Radiotherapy for Nasopharyngeal Carcinoma
NCT ID: NCT04813705
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
93 participants
INTERVENTIONAL
2022-01-01
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Reduced dose group
The patients achieving CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Reduced dose
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
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.
Conventional dose group
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
Conventional dose
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
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.
Interventions
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Reduced dose
The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
Conventional dose
The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Taizhou Enze Medical Center Group
OTHER
Taizhou Cancer Hospital
UNKNOWN
Taizhou Hospital
OTHER
Responsible Party
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Haihua Yang
Head of Department of Radiation Oncology
Principal Investigators
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Haihua Yang, MD
Role: PRINCIPAL_INVESTIGATOR
Taizhou Enze Medical Center Group
Locations
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Taizhou Central Hospital
Taizhou, Zhejiang, China
Taizhou Hospital
Taizhou, Zhejiang, China
Taizhou Cancer Hospital
Taizhou, Zhejiang, China
Taizhou Enze Medical Center(Group) Enze Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Shenpeng Ying
Role: primary
Guangxian You, MD
Role: primary
Other Identifiers
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PRR-202103
Identifier Type: -
Identifier Source: org_study_id
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