Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Paclitaxel liposome
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Complete Response (CR)
- Last Updated
- 6 years ago
Overview
Brief Summary
- To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).
Detailed Description
This phase II trial is studying how well radiation therapy and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Investigators
Hai-Qiang Mai,MD,PhD
Professor and Deputy Director
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- •Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
- •No evidence of distant metastasis (M0).
- •Age ≤ 18 years old.
- •Satisfactory performance status: Karnofsky scale (KPS) \>
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- •Adequate renal function: creatinine clearance ≥60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Age \>18 years.
- •Treatment with palliative intent.
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •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.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Arms & Interventions
Paclitaxel liposome, Cisplatin, 5-Fu,
Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Intervention: Paclitaxel liposome
Paclitaxel liposome, Cisplatin, 5-Fu,
Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Intervention: Cisplatin
Paclitaxel liposome, Cisplatin, 5-Fu,
Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Intervention: 5-fu
Paclitaxel liposome, Cisplatin, 5-Fu,
Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Intervention: Radical radiotherapy
Outcomes
Primary Outcomes
Complete Response (CR)
Time Frame: After the completion of the chemoradiotherapy treatment (up to 9 weeks)
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only
Secondary Outcomes
- Overall survival(OS)(3-year)
- Progress-free survival(PFS)(3-year)
- Locoregional failure-free survival(LRFS)(3-year)
- Distant metastasis-free survival(DMFS)(3-year)
- Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)(3 months)
- Long-term toxicities(Through study completion, an average of half year)
- Growth(Through study completion, an average of half year)
- Sex Development(Through study completion, an average of half year)
- Intelligence Development(Through study completion, an average of half year)