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NCT01872962 · CITED IN SOURCE DOCUMENTS

Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
UNKNOWN
Registry last update
2018-04-24

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). * Tumor staged as T3-4N1/N2-3 (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 ≥ 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 \> 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.
healthy Volunteers
false
maximum Age
65 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
    intervention Names
    1. Drug: gemcitabine and cisplatin (Induction chemotherapy)
    2. Radiation: IMRT and concurrent cisplatin
    label
    Induction chemotherapy+IMRT and concurrent cisplatin
    type
    EXPERIMENTAL
  2. description
    Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
    intervention Names
    1. Radiation: IMRT and concurrent cisplatin
    label
    IMRT and concurrent cisplatin
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Induction chemotherapy+IMRT and concurrent cisplatin
    description
    Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
    name
    gemcitabine and cisplatin (Induction chemotherapy)
    other Names
    1. gemcitabine and cisplatin (GP)
    type
    DRUG
  2. arm Group Labels
    1. IMRT and concurrent cisplatin
    2. Induction chemotherapy+IMRT and concurrent cisplatin
    description
    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, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
    name
    IMRT and concurrent cisplatin
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
480
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
    measure
    Failure-free survival
    time Frame
    3-year
secondary Outcomes
  1. description
    Overall survival is calculated from randomization to death from any cause.
    measure
    Overall survival
    time Frame
    3-year
  2. description
    Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
    measure
    Locoregional failure-free survival
    time Frame
    3-year
  3. description
    Distant failure-free survival is calculated from randomization to the first remote failure.
    measure
    Distant failure-free survival
    time Frame
    3-year
  4. description
    Incidence of acute and late toxicity
    measure
    Number of participants with adverse events
    time Frame
    up to 3 years
Full study description
brief Summary
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in patients with locoregionally advanced nasopharyngeal carcinoma(NPC), in order to confirm the value of induction chemotherapy in NPC patients.
detailed Description
Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with intensity-modulated radiotherapy (IMRT). 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. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Source references
references
  1. citation
    Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
    pmid
    21296855
    type
    BACKGROUND
  2. citation
    Edge SB, Byrd DR, Compton CC, et al: AJCC Cancer Staging Manual (ed 7th). New York, Springer, 2010
    type
    BACKGROUND
  3. citation
    Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.
    pmid
    20643517
    type
    BACKGROUND
  4. citation
    Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037.
    pmid
    16377415
    type
    BACKGROUND
  5. citation
    Langendijk JA, Leemans CR, Buter J, Berkhof J, Slotman BJ. The additional value of chemotherapy to radiotherapy in locally advanced nasopharyngeal carcinoma: a meta-analysis of the published literature. J Clin Oncol. 2004 Nov 15;22(22):4604-12. doi: 10.1200/JCO.2004.10.074.
    pmid
    15542811
    type
    BACKGROUND
  6. citation
    International Nasopharynx Cancer Study Group; VUMCA I Trial. Preliminary results of a randomized trial comparing neoadjuvant chemotherapy (cisplatin, epirubicin, bleomycin) plus radiotherapy vs. radiotherapy alone in stage IV(> or = N2, M0) undifferentiated nasopharyngeal carcinoma: a positive effect on progression-free survival. Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):463-9. doi: 10.1016/s0360-3016(96)80007-1.
    pmid
    8655368
    type
    BACKGROUND
  7. citation
    Chua DT, Sham JS, Choy D, Lorvidhaya V, Sumitsawan Y, Thongprasert S, Vootiprux V, Cheirsilpa A, Azhar T, Reksodiputro AH. Preliminary report of the Asian-Oceanian Clinical Oncology Association randomized trial comparing cisplatin and epirubicin followed by radiotherapy versus radiotherapy alone in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma. Asian-Oceanian Clinical Oncology Association Nasopharynx Cancer Study Group. Cancer. 1998 Dec 1;83(11):2270-83.
    pmid
    9840526
    type
    BACKGROUND
  8. citation
    Ma J, Mai HQ, Hong MH, Min HQ, Mao ZD, Cui NJ, Lu TX, Mo HY. Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma. J Clin Oncol. 2001 Mar 1;19(5):1350-7. doi: 10.1200/JCO.2001.19.5.1350.
    pmid
    11230478
    type
    BACKGROUND
  9. citation
    Hareyama M, Sakata K, Shirato H, Nishioka T, Nishio M, Suzuki K, Saitoh A, Oouchi A, Fukuda S, Himi T. A prospective, randomized trial comparing neoadjuvant chemotherapy with radiotherapy alone in patients with advanced nasopharyngeal carcinoma. Cancer. 2002 Apr 15;94(8):2217-23. doi: 10.1002/cncr.10473.
    pmid
    12001120
    type
    BACKGROUND
  10. citation
    Barton-Burke M. Gemcitabine: a pharmacologic and clinical overview. Cancer Nurs. 1999 Apr;22(2):176-83. doi: 10.1097/00002820-199904000-00011.
    pmid
    10217035
    type
    BACKGROUND
  11. citation
    Foo KF, Tan EH, Leong SS, Wee JT, Tan T, Fong KW, Koh L, Tai BC, Lian LG, Machin D. Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type. Ann Oncol. 2002 Jan;13(1):150-6. doi: 10.1093/annonc/mdf002.
    pmid
    11865813
    type
    BACKGROUND
  12. citation
    Ma BB, Tannock IF, Pond GR, Edmonds MR, Siu LL. Chemotherapy with gemcitabine-containing regimens for locally recurrent or metastatic nasopharyngeal carcinoma. Cancer. 2002 Dec 15;95(12):2516-23. doi: 10.1002/cncr.10995.
    pmid
    12467065
    type
    BACKGROUND
Source notices and limitations
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      1. context
        Updated: May 14, 2025
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    Preserved source evidence · Not medical advice