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Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era

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ClinicalTrials.gov Identifier: NCT02633202
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : December 13, 2018
Sponsor:
Collaborators:
Fifth Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Foshan
Guilin Medical University, China
Information provided by (Responsible Party):
Lei Chen, Sun Yat-sen University

Brief Summary:
Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above,the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: IMRT Drug: Cisplatin Phase 3

Detailed Description:
Currently, concurrent chemoradiotherapy with/without sequential chemotherapy is the standard treatment modality for intermediate risk NPC (stage II and T3N0M0) according to the National Comprehensive Cancer Network guideline. However these recommendations were based on the evidence in the two-dimensional conventional radiotherapy (2DCRT) era. The introduction of intensity-modulated radiotherapy (IMRT) in NPC treatment has brought substantial better treatment outcomes than 2DCRT. It has been questioned whether additional concurrent chemotherapy is still necessary for intermediate risk NPC within the excellent framework of IMRT. Thus, the investigators jointly conduct the first non-inferior randomized trial to determine the value of concurrent chemotherapy with cisplatin for intermediate risk NPC patients treated with IMRT. Given the results of clinical studies mentioned above, the investigators decide to adopt the concurrent regimen to be cisplatin 100 mg/m2 on day 1, 22, 43

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Non-inferior Clinical Trial Comparing Concurrent Chemoradiotherapy or Radiotherapy Alone in Patients With Intermediate Risk Nasopharyngeal Carcinoma in Intensity-modulated Radiotherapy Era
Study Start Date : November 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: RT group
intensity modulated-radiotherapy (IMRT) alone: Patients receive intensity modulated-radiotherapy (IMRT) alone
Radiation: IMRT
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor
Other Name: Intensity-modulated radiation therapy

Active Comparator: CCRT group
IMRT and concurrent cisplatin Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles
Radiation: IMRT
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor
Other Name: Intensity-modulated radiation therapy

Drug: Cisplatin
concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles during IMRT
Other Name: Concurrent cisplatin regimen




Primary Outcome Measures :
  1. Failure-free survival [ Time Frame: 3 Year ]
    The failure-free survival rate will be estimated using the Kaplan-Meier method for each arm from the date of randomization to the date of treatment failure or death from any cause, whichever is first. Their differences will be compared between treatment arms using the log-rank test.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 Year ]
    The overall survival rate will be estimated using the Kaplan-Meier method for each arm from randomization to death from any cause. Their differences will be compared between treatment arms using the log-rank test.

  2. Locoregional failure-free survival [ Time Frame: 3 Year ]
    The locoregional failure-free survival will be estimated using the Kaplan-Meier method for each arm from randomization to the first locoregional failure. Their differences will be compared between treatment arms using the log-rank test.

  3. Distant failure-free survival [ Time Frame: 3 Year ]
    The distant failure-free survival will be estimated using the Kaplan-Meier method for each arm from randomization to the first remote failure. Their differences will be compared between treatment arms using the log-rank test.

  4. Rates of participants with adverse events [ Time Frame: 3 Year ]
    Acute and late toxicities will be documented according to the Common Terminology Criteria for Adverse Events version 3.0 and/or the Radiation Morbidity Scoring Criteria of the Radiation Therapy Oncology Group. Rates of the toxicities will be estimated using a binomial distribution along and will be compared using Fisher's exact test between the 2 treatment arms.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type.
  • Tumor staged as T1-2N1/T2-3N0(according to the 7th AJCC edition).
  • No evidence of distant metastasis (M0).
  • Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
  • Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 120g/L for male, ≥ 120g/L for female , 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:

  • Neck lymph node with extracapsular spread. Maximal axial diameter of neck lymph node ≥30mm, positive neck lymph node at level IV and/or Vb.
  • Pretreatment plasma EBV DNA level ≥4000 copy/ml.
  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age > 65 or < 18.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • History of previous RT (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): NCT02633202


Contacts
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Contact: Lei Chen, M.D. +86-20-87343096 chenlei@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Lei Chen, M.D.    +86-20-87343096    chenlei@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Fifth Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Foshan
Guilin Medical University, China
Investigators
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Study Chair: Lei Chen, M.D. Sun Yat-sen University
Publications:

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Responsible Party: Lei Chen, M.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02633202    
Other Study ID Numbers: IRNPC15
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Keywords provided by Lei Chen, Sun Yat-sen University:
Nasopharyngeal carcinoma
Concurrent chemoradiotherapy
intermediate risk
intensity-modulated radiotherapy
Additional relevant MeSH terms:
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Carcinoma
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
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents