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

NCT ID: NCT00997906

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-15
• Study Completion Date: 2023-12-31

Brief 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.

Detailed Description

OBJECTIVES:

Primary

• To compare the 5-year overall survival of patients with locally advanced nasopharyngeal cancer treated with concurrent cisplatin and radiotherapy with vs without induction chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.

Secondary

• To assess and compare the disease-free survival, distant metastases rate, toxicities, and quality of life of patients treated with these regimens.

OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).
• Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for a total of 33 fractions).

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

intensity-modulated radiation therapy

Intervention Type: RADIATION

Given once daily 5 days a week for 6½ weeks.

Arm II

Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after the last dose of induction chemotherapy, patients receive cisplatin and undergo radiotherapy as in arm I.

Group Type: EXPERIMENTAL

carboplatin,

Intervention Type: DRUG

Given IV

cisplatin

Intervention Type: DRUG

Given IV

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

intensity-modulated radiation therapy

Intervention Type: RADIATION

Given once daily 5 days a week for 6½ weeks.

Interventions

carboplatin,

Given IV

Intervention Type: DRUG

cisplatin

Given IV

Intervention Type: DRUG

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

intensity-modulated radiation therapy

Given once daily 5 days a week for 6½ weeks.

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Terence Tan Wee Kiat

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terence Tan, FRCR

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre - Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

SINGAPORE-NCC0901

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000657121

Identifier Type: -

Identifier Source: org_study_id