Clinical trial NCT03020329: Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Children
Keywords: Induction Chemotherapy
Nasopharyngeal carcinoma
Chemoradiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 37
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. 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.

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) \> 70.
* 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.

Primary outcomes:
measure: Complete Response (CR)
timeFrame: After the completion of the chemoradiotherapy treatment (up to 9 weeks)
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3-year
measure: Progress-free survival(PFS)
timeFrame: 3-year
measure: Locoregional failure-free survival(LRFS)
timeFrame: 3-year
measure: Distant metastasis-free survival(DMFS)
timeFrame: 3-year
measure: Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
timeFrame: 3 months
measure: Long-term toxicities
timeFrame: Through study completion, an average of half year
measure: Long-term toxicities
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Growth
timeFrame: Through study completion, an average of half year
measure: Sex Development
timeFrame: Through study completion, an average of half year
measure: Sex Development
timeFrame: Through study completion, an average of half year
measure: Intelligence Development
timeFrame: Through study completion, an average of half year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Cancer center
name: HaiQiang Mai, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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