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

September 27, 2022 updated by: Terence Tan Wee Kiat, National Cancer Centre, Singapore

A Randomised Phase II/III Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 169610
        • National Cancer Centre - Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Given IV
Given once daily 5 days a week for 6½ weeks.
Experimental: 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.
Given IV
Given IV
Given IV
Given once daily 5 days a week for 6½ weeks.
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival at 5 years
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: 10 years
10 years
Metastases-free survival
Time Frame: 10 years
10 years
Tumor recurrence
Time Frame: 10 years
10 years
Toxicity according to the Common Toxicity Criteria
Time Frame: 10 years
10 years
Quality of life as measured by the EORTC QLQ-C30
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Terence Tan, FRCR, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2009

Primary Completion (Actual)

December 31, 2017

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 17, 2009

First Submitted That Met QC Criteria

October 17, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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