Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
Condition: Stage II Lymphoepithelioma of the Nasopharynx; Stage II Squamous Cell Carcinoma of the Nasopharynx; Stage III Lymphoepithelioma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage IV Lymphoepithelioma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and
      fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy
      works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy,
      such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a
      high dose of radiation directly to the tumor may kill more tumor cells and cause less damage
      to normal tissue. Giving combination chemotherapy together with radiation therapy may kill
      more tumor cells.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      • To establish the progression free survival rate at 2 years, using RECIST criteria, to
      induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by
      chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC)

      SECONDARY OBJECTIVE:

      • To evaluate complete response rates, safety and feasibility of TPF followed by
      chemoradiation in patients with NPC

      OUTLINE: This is a single site study.

      INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1;
      cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil
      IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment
      consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity.

      CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course
      of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated
      radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour
      (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease
      progression or unacceptable toxicity.

      All study treatment is admininstered over the course of 21 weeks. After completion of study
      treatment, patients are followed periodically for 24 months.
    

Intervention name(s): docetaxel; cisplatin; carboplatin; fluorouracil; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Radiation; Radiation
Intervention description(s): Given IV; Given IV; Given IV; Given IV; Undergo 3-dimensional conformal or intensity-modulated radiotherapy; Undergo 3-dimensional conformal or intensity-modulated radiotherapy
Other intervention name(s): RP 56976; Taxotere; TXT; CACP; CDDP; CPDD; DDP; Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; 5-fluorouracil; 5-Fluracil; 5-FU; 3D conformal radiation therapy; 3D-CRT; IMRT
Intervention MeSH terms: Carboplatin; Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment