Brief Title
Concurrent Chemotherapy for the Intermediate Risk Nasopharyngeal Carcinoma In Intensity-modulated Radiotherapy Era
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
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
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Failure-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
IMRT
Study Arms / Comparison Groups
RT group
Description: intensity modulated-radiotherapy (IMRT) alone: Patients receive intensity modulated-radiotherapy (IMRT) alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
338
Start Date
November 2015
Completion Date
December 2021
Primary Completion Date
December 2019
Eligibility 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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Lei Chen, M.D., +86-20-87343096, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02633202
Organization ID
IRNPC15
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Study Sponsor
Lei Chen, M.D., Study Chair, Sun Yat-sen University
Verification Date
December 2018