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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Terence Tan Wee Kiat, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT00997906
First received: October 17, 2009
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: carboplatin,
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Radiation: intensity-modulated radiation therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • Overall survival at 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metastases-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Tumor recurrence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Toxicity according to the Common Toxicity Criteria [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Quality of life as measured by the EORTC QLQ-C30 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: September 2009
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: cisplatin
Given IV
Radiation: intensity-modulated radiation therapy
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.
Drug: carboplatin,
Given IV
Drug: cisplatin
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: paclitaxel
Given IV
Radiation: intensity-modulated radiation therapy
Given once daily 5 days a week for 6½ weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997906

Locations
Singapore
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
Principal Investigator: Terence Tan, FRCR National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided

Responsible Party: Terence Tan Wee Kiat, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00997906     History of Changes
Other Study ID Numbers: CDR0000657121, SINGAPORE-NCC0901
Study First Received: October 17, 2009
Last Updated: April 28, 2015
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National Cancer Centre, Singapore:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Carboplatin
Cisplatin
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on July 29, 2015