A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

Phase 3

Completed

• Conditions: Nasopharyngeal Cancer
• Interventions: Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)

• Registration Number: NCT00370890
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2006-08-30
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-09-01
• Study Start: 2006-09-04
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Adjuvant chemotherapy (gemcitabine and cisplatin)	Adjuvant chemotherapy and then clinical follow-up and surveillance

Primary Outcome Measures

Name	Time	Method
Relapse free survival	5 years

Secondary Outcome Measures

Name	Time	Method
Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome	5 years
Overall survival	5 years	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
Loco-regional control	5 years
Metastasis-free survival	5 years
Toxicity of adjuvant chemotherapy	6 months

Trial Locations

Locations (6)

Department of Clinical Oncology, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Department of Oncology, Princess Margaret Hospital; 🇭🇰 Hong Kong, 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, Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong