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

NCT ID: NCT00370890

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-04
• Study Completion Date: 2021-10-26

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.

Conditions

Nasopharyngeal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Adjuvant chemotherapy and then clinical follow-up and surveillance

Group Type: EXPERIMENTAL

Adjuvant chemotherapy (gemcitabine and cisplatin)

Intervention Type: DRUG

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

B

Clinical follow-up and surveillance only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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 Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Nasopharyngeal Cancer Study Group Limited

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Edwin P Hui

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony TC Chan, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Roger KC Ngan, FRCR

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong

Locations

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, , Hong Kong

Countries

Hong Kong

References

Chua ML, Chan AT. Gemcitabine: a game changer in nasopharyngeal carcinoma. Lancet. 2016 Oct 15;388(10054):1853-1854. doi: 10.1016/S0140-6736(16)31394-0. Epub 2016 Aug 23. No abstract available.

Reference Type: DERIVED

PMID: 27567280 (View on PubMed)

Other Identifiers

HKNPCSG 0502

Identifier Type: -

Identifier Source: org_study_id