Clinical trial NCT01596868: GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China
Official title: A Randomized, Phase II Trial Comparing Induction Chemotherapy Gemcitabine Plus Cisplatin With Docetaxel Plus Cisplatin Followed by Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma in Northwest China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Squamous Cell Carcinoma
Toxicity Due to Radiotherapy
Keywords: Advanced Nasopharyngeal Carcinoma
treatment
Northwest China
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is a randomized, control, phase II study of locally advanced nasopharyngeal carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC). The effectiveness, side effects and quality of life will be evaluated according to Standard WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H\&N35 questionnaire.

Detailed description: Nasopharyngeal carcinoma has an unique geographic distribution, and has different pathological types, natural history, treatment modalities in endemic and non-endemic regions. Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. Chemoradiotherapy is the main therapy choice for the locoregionally advanced nasopharyngeal carcinoma. However,the optimal chemoradiotherapy regimen has not been determined. Many new drugs including docetaxel and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The investigators designed the present study with induction chemotherapy follow by CCRT for locoregionally advanced NPC in non-endemic Northwest China, comparing induction chemotherapy regime of TP and GP. The primary objectives were overall response rate (ORR), acute toxicity, tolerance; second objective were overall survival (OS), progression free survival (PFS), rate of distant metastases,late adverse events and quality of life.

Eligibility criteria: Inclusion Criteria:

* Histologically proven WHO II\~III native NPC in northwest region of China;
* 18 Years to 70 Years;
* stages III-IVb according to AJCC stage classification(7th edition), no previous chemotherapy and radiotherapy;
* Performance status: 0-1(ECOG);
* WBC \> 4.0X109/L, PLT \> 100X109/L, with normal hepatic function(AST, ALT \< 2.5 x upper limit of normal, and bilirubin \< 1.5 x upper limit of normal), with normal renal function (Creatinine \< 1.5 x upper limit of normal);
* Ability to comply with trial requirements.

Exclusion Criteria:

* Evidence of metastases by clinical or radiographic examinations;
* History of malignancy;
* Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.;
* Patients with uncontrolled intercurrent disease;
* Patients with currently active malignancy;
* Pregnant or lactating women patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: 3-year
Secondary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Locoregional failure-free survival
timeFrame: 3-year
measure: Distant failure-free survival
timeFrame: 3-year
measure: Number of Participants with Adverse Events
timeFrame: 3-year
measure: Quality of life
timeFrame: 3-year
measure: Acute adverse reaction
timeFrame: 3-year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Radiation Oncology, Xijing Hospital, Fourth Military
state: Shanxi
Study officials:
affiliation: department of radiation oncology
name: Mei Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: