The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

Brief Title

The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

Official Title

Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma

Brief Summary

      The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT)
      alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally
      advanced nasopharyngeal carcinoma.

Detailed Description

      -  There were several randomized clinical trials confirmed that concurrent
           chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC,
           most of the patients in the trials were treated with conventional radiotherapy
           technique.

        -  As the new technique of IMRT used more and more in the clinical practice, the role of
           concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII
           studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal
           radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in
           terms of overall survival between RT alone and CCRT groups. Furthermore, several large
           sample size retrospective studies from China, showed that there were no advantage of
           CCRT over RT alone when treated by SIB-IMRT.

        -  In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the
           author divided the locally advanced NPC patients into two groups, with the high-risk
           group defined as patients met at least one of following criteria: nodal size >6 cm, (2)
           supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node
           >4cm.

        -  Based on these information, we hypothesize that, for low-risk locally advanced NPC
           patients, there may no need CCRT under SIB-IMRT treatment.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

overall survival

Secondary Outcome

 Acute and late toxicities

Condition

Nasopharyngeal Carcinoma

Intervention

SIB-IMRT

Study Arms / Comparison Groups

 RT alone

Description:  SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

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

Start Date

April 2013

Completion Date

April 2020

Primary Completion Date

July 30, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Histopathological proven non-keratin nasopharyngeal carcinoma

          -  AJCC 7th edition stage III/IVM0, without any one of following factors: node size
             >6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node
             >4 cm

          -  Life expectancy≥6 months

          -  Adequate renal function, defined as follows: Serum creatinine < 2 x institutional
             upper limit of normal(ULN) within 2 weeks prior to registration or creatinine
             clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by
             24- hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x
             (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCrmale)

          -  The following assessments are required within 2 weeks prior to the start of
             registration: Na, K, Cl, glucose, Ca, Mg, and albumin

        Exclusion Criteria:

          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the
             breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed
             and treated < 3 years ago

          -  Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields

          -  Severe, active co-morbidity

          -  Treatment planning does not meet the requirement of prescription dose.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Li Gao, MD, 861087788504, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01817023

Organization ID

CH-HN-003

Responsible Party

Principal Investigator

Study Sponsor

Chinese Academy of Medical Sciences

Study Sponsor

Li Gao, MD, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Verification Date

May 2019