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

NCT00370890 | Completed Phase 3 DMC

• 1 other identifier: HKNPCSG 0502
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

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.

Conditions

Nasopharyngeal Cancer

Keywords

nasopharyngeal cancer; adjuvant chemotherapy; EBV DNA; PET CT scan

Outcome Measures

Primary Outcomes (1)

• Relapse free survival

  5 years

Secondary Outcomes (5)

• Overall survival

  5 years

• Loco-regional control

  5 years

• Metastasis-free survival

  5 years

• Toxicity of adjuvant chemotherapy

  6 months

• Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome

  5 years

Study Arms (2)

A

EXPERIMENTAL

Adjuvant chemotherapy and then clinical follow-up and surveillance

Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)

B

NO INTERVENTION

Clinical follow-up and surveillance only

Interventions

Adjuvant chemotherapy (gemcitabine and cisplatin) 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

A

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• Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.
• 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.
• Loco-regional advanced NPC UICC/AJCC Stages IIB, III, IVA or IVB.
• No evidence of distant metastases in the staging work up at diagnosis.
• Must have detectable plasma EBV-DNA (\> 0 copies/ml) at 6-8 weeks after completion of primary RT or chemo-RT
• No clinical evidence of persistent loco-regional disease after primary treatment
• Performance status of ECOG grade 0 or 1.
• 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
• At least 18 years of age, of either sex.
• 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.

You may not qualify if:

• 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).
• More that 12 weeks after completion of primary radiotherapy.
• Had received prior adjuvant chemotherapy.
• Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Have serious active infection.
• Patients with peripheral or ototoxicity with a grade of greater than 2.
• Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong Nasopharyngeal Cancer Study Group Limited: collaborator

Study Sites (6)

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Department of Clinical Oncology, Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Department of Clinical Oncology, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Department of Clinical Oncology, Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Department of Oncology, Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 27567280 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Chemotherapy, Adjuvant; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Anthony TC Chan, MD, FRCP

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

  PRINCIPAL INVESTIGATOR

• Roger KC Ngan, FRCR

  Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: September 1, 2006
• Study Start: September 4, 2006
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

HK (6)