Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients Wi… (NCT00997906) | Clinical Trial Compass
UnknownPhase 2/3
Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC
Singapore172 participantsStarted 2009-09-15
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine hydrochloride, carboplatin, and paclitaxel, 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. Giving chemotherapy together with radiation therapy my kill more tumor cells. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with nasopharyngeal cancer.
PURPOSE: This randomized phase II/III trial is studying how well giving cisplatin together with radiation therapy works compared with giving cisplatin and radiation therapy together with gemcitabine hydrochloride, carboplatin, and paclitaxel in treating patients with locally advanced nasopharyngeal cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice.
✓. Loco-regional advanced NPC UICC (1997) Stages T3 - 4 any N, or any Stage T, N2 - 3.
✓. A histological diagnosis of WHO Type II or III NPC must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization.
✓. No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
✓. Cross sectional imaging of the primary and neck disease (MRI preferred)
✓. Evaluable disease must be present.
✓. Performance status of ECOG grade 0 or 1 (see Appendix I).