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Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03020329
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

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).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Children Drug: Paclitaxel liposome Drug: Cisplatin Drug: 5-fu Radiation: Radical radiotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Actual Study Start Date : November 14, 2016
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Concurrent radiotherapy




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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. 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

  4. 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

  5. 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)

  6. 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)

  7. Long-term toxicities [ Time Frame: Through study completion, an average of half year ]
    EORTC quality of life questionnaire(QLQ) Head and Neck

  8. Growth [ Time Frame: Through study completion, an average of half year ]
    Patients will be monitored for height(in metre)

  9. Growth [ Time Frame: Through study completion, an average of half year ]
    Patients will be monitored for weight(in kilogram)

  10. Growth [ Time Frame: Through study completion, an average of half year ]
    Patients will be monitored for BMI(in kg/m^2)

  11. Sex Development [ Time Frame: Through study completion, an average of half year ]
    Sex hormone(estrogen,testosterone) levels(in nmol/L)

  12. Sex Development [ Time Frame: Through study completion, an average of half year ]
    Secondary sex characteristic survey

  13. Intelligence Development [ Time Frame: Through study completion, an average of half year ]
    Intelligence quotient by Stanford-Binet test



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020329


Contacts
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Contact: DongHua Luo, MD,PhD 8620-87343643 luodh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: HaiQiang Mai, PhD    8620-38606186    maihq@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: HaiQiang Mai, MD,PhD Cancer center

Additional Information:
Publications:

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Responsible Party: Hai-Qiang Mai,MD,PhD, Professor and Deputy Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03020329     History of Changes
Other Study ID Numbers: NPC in Young Patients
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University:
Induction Chemotherapy
Nasopharyngeal carcinoma
Chemoradiotherapy
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs