Chemoradiation | Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
Chemoradiation research study
What is the primary objective of this study?
Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.
Who is eligible to participate?
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system) 3. No evidence of distant metastasis(M0) 4. Performance status:KPS>70 5. With normal liver function test(ALT, AST<1.5ULN) 6. Renal:creatinine clearance >60ml/min 7. Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L. 8. With controled blood glucose for diabetes patients 9. Written informed consent Exclusion Criteria: 1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age>70 or <18 3. With a history of renal disease 4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0 5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume) 6. Patient is pregnant or lactating . 7. Peripheral neuropathy 8. Emotional disturbance
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PF (cisplatin and 5-fluorouracil) groupthe group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
Drug:TPF (docetaxel plus cisplatin and 5-fluorouracil) group3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PF groupthe group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy
TPF groupTPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy
Start Date: April 2012
Completed Date: February 2015
Phase: Phase 3
Primary Outcome: 3-year progress free survival(PFS)
Secondary Outcome: overall survival(OS)
Study sponsors, principal investigator, and references
Principal Investigator: Xiaozhong Chen, MD
Lead Sponsor: Zhejiang Cancer Hospital
Collaborator: Second Affiliated Hospital, School of Medicine, Zhejiang University