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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00370890
Other study ID # HKNPCSG 0502
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 4, 2006
Est. completion date October 26, 2021

Study information

Verified date February 2022
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.


Description:

- The standard treatment for nasopharynx cancer is a course of radiotherapy with or without concurrent chemotherapy. This will cure about 80% of patients. For the 20% who developed recurrence or metastases, the prognosis is poor. - Elevated EBV-DNA in plasma at end of radiotherapy has been shown to predict disease recurrence and may be a marker of subclinical residual disease. - This study aims to test whether adjuvant treatment with 6 cycles of a modern chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival of these high risk patients of nasopharynx cancer who have elevated EBV-DNA after completion of their radiotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date October 26, 2021
Est. primary completion date October 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice. 2. A histological diagnosis of nasopharyngeal cancer (NPC) must have been established at some time and the investigator must review and confirm the diagnosis prior to randomization. 3. Loco-regional advanced NPC UICC/AJCC Stages IIB, III, IVA or IVB. 4. No evidence of distant metastases in the staging work up at diagnosis. 5. Must have detectable plasma EBV-DNA (> 0 copies/ml) at 6-8 weeks after completion of primary RT or chemo-RT 6. No clinical evidence of persistent loco-regional disease after primary treatment 7. Performance status of ECOG grade 0 or 1. 8. Patients must have adequate organ and marrow function as defined below: leukocytes >3,000/L; absolute neutrophil count >1,500/L; platelets >100,000/L; total bilirubin <1.5 X institutional upper limit of normal; AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal; Creatinine clearance > 50 ml/min 9. At least 18 years of age, of either sex. 10. If female, must be either (i) post-menopausal or surgically sterilized, or (ii) use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide for the duration of the study and must be neither pregnant nor breast-feeding. Exclusion Criteria: 1. 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. More that 12 weeks after completion of primary radiotherapy. 4. Had received prior adjuvant chemotherapy. 5. Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator). 6. Have serious active infection. 7. Patients with peripheral or ototoxicity with a grade of greater than 2. 8. Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.

Study Design


Intervention

Drug:
Adjuvant chemotherapy (gemcitabine and cisplatin)
Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles

Locations

Country Name City State
Hong Kong Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital Hong Kong
Hong Kong Department of Clinical Oncology, Prince of Wales Hospital Hong Kong
Hong Kong Department of Clinical Oncology, Queen Elizabeth Hospital Hong Kong
Hong Kong Department of Clinical Oncology, Queen Mary Hospital Hong Kong
Hong Kong Department of Clinical Oncology, Tuen Mun Hospital Hong Kong
Hong Kong Department of Oncology, Princess Margaret Hospital Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong Hong Kong Nasopharyngeal Cancer Study Group Limited

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse free survival 5 years
Secondary Overall survival Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up 5 years
Secondary Loco-regional control 5 years
Secondary Metastasis-free survival 5 years
Secondary Toxicity of adjuvant chemotherapy 6 months
Secondary Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome 5 years
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