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

Primary Purpose

Head and Neck Cancer

Status

Active

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

carboplatin,

cisplatin

gemcitabine hydrochloride

paclitaxel

intensity-modulated radiation therapy

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice.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).
No prior tumour therapy
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.
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:

Uncontrolled hypercalcaemia: calcium ≥ 2.7 mmol/L (10.8 mg/dL).
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Have serious active infection.
Hepatitis B carrier
Prior treatment including chemotherapy or radiotherapy.
Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.

Sites / Locations

National Cancer Centre - Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm I

Arm II

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Overall survival at 5 years

Secondary Outcome Measures

Metastases-free survival

Disease-free survival

Tumor recurrence

Toxicity according to the Common Toxicity Criteria

Quality of life as measured by the EORTC QLQ-C30

Full Information

NCT ID

NCT00997906

First Posted

October 17, 2009

Last Updated

September 27, 2022

Sponsor

National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT00997906

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 15, 2009 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Centre, Singapore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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 Title

Arm II

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

carboplatin,

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

Given IV

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Intervention Description

Given once daily 5 days a week for 6½ weeks.

Primary Outcome Measure Information:

Title

Overall survival at 5 years

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Metastases-free survival

Time Frame

10 years

Title

Disease-free survival

Time Frame

10 years

Title

Tumor recurrence

Time Frame

10 years

Title

Toxicity according to the Common Toxicity Criteria

Time Frame

10 years

Title

Quality of life as measured by the EORTC QLQ-C30

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients are eligible for inclusion if all of the following criteria are fulfilled: 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). No prior tumour therapy 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. 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: Uncontrolled hypercalcaemia: calcium ≥ 2.7 mmol/L (10.8 mg/dL). Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin). Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). Have serious active infection. Hepatitis B carrier Prior treatment including chemotherapy or radiotherapy. Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terence Tan, FRCR

Organizational Affiliation

National Cancer Centre, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Centre - Singapore

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

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

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