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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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，white blood cell count (ANC) at least 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 willing to sign a consent form. 10. Have follow up condition. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (4)

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