Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

August 6, 2019 updated by: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

1. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Paclitaxel liposome

Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy.

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.

Other Names:
  • Paclitaxel liposome,cisplatin,fluorouracil(TPF) chemotherapy
Drug: Cisplatin
Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.
Other Names:
  • TPF induction chemotherapy
  • Concurrent cisplatin
Drug: 5-fu
Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.
Other Names:
  • TPF induction chemotherapy
Radiation: Radical radiotherapy
Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.
Other Names:
  • Concurrent radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After the completion of the chemoradiotherapy treatment (up to 9 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Time Frame: 3 months
The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
3 months
Long-term toxicities
Time Frame: Through study completion, an average of half year
QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)
Through study completion, an average of half year
Long-term toxicities
Time Frame: Through study completion, an average of half year
EORTC quality of life questionnaire(QLQ) Head and Neck
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for height(in metre)
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for weight(in kilogram)
Through study completion, an average of half year
Growth
Time Frame: Through study completion, an average of half year
Patients will be monitored for BMI(in kg/m^2)
Through study completion, an average of half year
Intelligence Development
Time Frame: Through study completion, an average of half year
Intelligence quotient by Stanford-Binet test
Through study completion, an average of half year
Overall survival(OS)
Time Frame: 3-year
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
3-year
Progress-free survival(PFS)
Time Frame: 3-year
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
3-year
Locoregional failure-free survival(LRFS)
Time Frame: 3-year
The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
3-year
Distant metastasis-free survival(DMFS)
Time Frame: 3-year
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
3-year
Sex Development
Time Frame: Through study completion, an average of half year
Sex hormone(estrogen,testosterone) levels(in nmol/L)
Through study completion, an average of half year
Sex Development
Time Frame: Through study completion, an average of half year
Secondary sex characteristic survey
Through study completion, an average of half year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: HaiQiang Mai, MD,PhD, Cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2016

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC in Young Patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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