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

NCT00997906 | Unknown Phase 2 DMC

• 2 other identifiers: CDR0000657121SINGAPORE-NCC0901
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall survival at 5 years

  5 years

Secondary Outcomes (5)

• Metastases-free survival

  10 years

• Disease-free survival

  10 years

• Tumor recurrence

  10 years

• Toxicity according to the Common Toxicity Criteria

  10 years

• Quality of life as measured by the EORTC QLQ-C30

  5 years

Study Arms (2)

Arm I

EXPERIMENTAL

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; Radiation: intensity-modulated radiation therapy

Arm II

EXPERIMENTAL

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,; Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Radiation: intensity-modulated radiation therapy

Interventions

carboplatin, DRUG

Given IV

Arm II

cisplatin DRUG

Given IV

Arm I; Arm II

gemcitabine hydrochloride DRUG

Given IV

Arm II

paclitaxel DRUG

Given IV

Arm II

intensity-modulated radiation therapy RADIATION

Given once daily 5 days a week for 6½ weeks.

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Terence Tan, FRCR

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: October 17, 2009
• First Posted: October 20, 2009
• Study Start: September 15, 2009
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)