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| Name | Class |
|---|---|
| Hong Kong Nasopharyngeal Cancer Study Group Limited | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Adjuvant chemotherapy and then clinical follow-up and surveillance |
|
| B | No Intervention | Clinical follow-up and surveillance only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Loco-regional control |
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Inclusion Criteria:
Have given written informed consent, prior to pre-study screening, with the understanding that consent may be withdrawn at any time without prejudice.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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital | Hong Kong | Hong Kong | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27567280 | Derived | 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. |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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