GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Toxicity Due to Radiotherapy; Nasopharyngeal Squamous Cell Carcinoma

Treatments: Drug: gemcitabine and cisplatin; Drug: docetaxel and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01596868

Mshi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Gemcitabine and Cisplatin

Active Comparator group

Description:

Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT..

Treatment:

Drug: gemcitabine and cisplatin

docetaxel and cisplatin

Active Comparator group

Description:

Drug: Docetaxel and cisplatin TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.

Treatment:

Drug: docetaxel and cisplatin