Cisplatin and RT With or Without Gemcitabine, Carboplatin, and Paclitaxel in Treating Patients With Locally Advanced NPC

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel

Criteria

Inclusion criteria:

Patients are eligible for inclusion if all of the following criteria are fulfilled:

1. Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice.

2. Loco-regional advanced NPC UICC (1997) Stages T3 - 4 any N, or any Stage T, N2 - 3.

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.

4. No evidence of distant metastases in staging work up (including lung, liver and bone imaging).

5. Cross sectional imaging of the primary and neck disease (MRI preferred)

6. Evaluable disease must be present.

7. Performance status of ECOG grade 0 or 1 (see Appendix I).

8. No prior tumour therapy

9. Adequate bone marrow, renal and hepatic function:

Bone marrow : WBC > 3000 / mm3 (ANC > 1500 / mm3 ),

• Platelets > 100 000 / mm3,

• Hb > 10 gm/dl Renal : serum creatinine within institutional normal range (or) lower than the lower limit of institutional normal range

• calculated creatinine clearance > 50 ml / min Hepatic : enzymes (SAP, SGOT) < 2x normal

• bilirubin < 24 µmol / l.

10. At least 18 years of age, of either sex.

Exclusion criteria:

Patients are to be excluded from the study if any of the following criteria is fulfilled:

1. Uncontrolled hypercalcaemia: calcium ≥ 2.7 mmol/L (10.8 mg/dL).

2. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).

3. Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).

4. Have serious active infection.

5. Hepatitis B carrier

6. Prior treatment including chemotherapy or radiotherapy.

7. Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.