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Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, Children

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel liposome

Cisplatin

5-fu

Radical radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Induction Chemotherapy, Nasopharyngeal carcinoma, Chemoradiotherapy

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel liposome, Cisplatin, 5-Fu,

Arm Description

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.

Outcomes

Primary Outcome Measures

Complete Response (CR)

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 Outcome Measures

Overall survival(OS)

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.

Progress-free survival(PFS)

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

Locoregional failure-free survival(LRFS)

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

Distant metastasis-free survival(DMFS)

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

Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Long-term toxicities

QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)

Long-term toxicities

EORTC quality of life questionnaire(QLQ) Head and Neck

Growth

Patients will be monitored for height(in metre)

Growth

Patients will be monitored for weight(in kilogram)

Growth

Patients will be monitored for BMI(in kg/m^2)

Sex Development

Sex hormone(estrogen,testosterone) levels(in nmol/L)

Sex Development

Secondary sex characteristic survey

Intelligence Development

Intelligence quotient by Stanford-Binet test

Full Information

NCT ID

NCT03020329

First Posted

December 14, 2016

Last Updated

August 6, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03020329

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 14, 2016 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Children

Keywords

Induction Chemotherapy, Nasopharyngeal carcinoma, Chemoradiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel liposome, Cisplatin, 5-Fu,

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel liposome

Other Intervention Name(s)

Paclitaxel liposome,cisplatin,fluorouracil(TPF) chemotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

TPF induction chemotherapy, Concurrent cisplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

5-fu

Other Intervention Name(s)

TPF induction chemotherapy

Intervention Description

Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

Radical radiotherapy

Other Intervention Name(s)

Concurrent radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Complete Response (CR)

Description

Time Frame

After the completion of the chemoradiotherapy treatment (up to 9 weeks)

Secondary Outcome Measure Information:

Title

Overall survival(OS)

Description

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.

Time Frame

3-year

Title

Progress-free survival(PFS)

Description

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

Time Frame

3-year

Title

Locoregional failure-free survival(LRFS)

Description

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

Time Frame

3-year

Title

Distant metastasis-free survival(DMFS)

Description

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

Time Frame

3-year

Title

Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Description

The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Time Frame

3 months

Title

Long-term toxicities

Description

QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)

Time Frame