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| Name | Class |
|---|---|
| The Hong Kong Anti-Cancer Society | OTHER |
| hong Kong Cancer Fund | UNKNOWN |
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The objectives of this clinical study are threefold:
primary objectives include
secondary objectives include
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A | Experimental | Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy |
|
| 1B | Experimental | Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy |
|
| 2A | Experimental | Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy |
|
| 2B | Experimental | Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy |
|
| 3A | Experimental | Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy |
|
| 3B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year. | 5 years | |
| Overall Survival, defined as the time to death due to any cause, at 5-year. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall Failure-Free Rate, defined as time to failure at any site) | 5 years | |
| Loco-regional Failure-Free Rate, defined as time to local or nodal failure) | 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne W.M. Lee, F.R.C.R. | Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong | Principal Investigator |
| Roger K.C. Ngan, F.R.C.R | Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat Sen University | Guangzhou | China | ||||
| Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9552031 | Background | Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. doi: 10.1200/JCO.1998.16.4.1310. | |
| 16192584 | Background |
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Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy |
|
| Adjuvant chemotherapy using PF (5-Fluorouracil ) | Drug | Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles |
|
| Induction chemotherapy using PF (5-Fluorouracil) | Drug | Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles |
|
| Distant Failure-Free Rate, defined as time to distant failure) |
| 5 years |
| Incidence of chemotherapy toxicity and acute RT toxicity grade > 3 | treatment |
| Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3) | 5 years |
| Hong Kong |
| China |
| Department of Clinical Oncology, Prince of Wales Hospital | Hong Kong | China |
| Department of Clinical Oncology, Princess Margaret Hospital | Hong Kong | China |
| Department of Clinical Oncology, Queen Elizabeth Hospital | Hong Kong | China |
| Department of Clinical Oncology, Queen Mary Hospital | Hong Kong | China |
| Department of Clinical Oncology, Tuen Mun Hospital | Hong Kong | China |
| Lee AW, Lau WH, Tung SY, Chua DT, Chappell R, Xu L, Siu L, Sze WM, Leung TW, Sham JS, Ngan RK, Law SC, Yau TK, Au JS, O'Sullivan B, Pang ES, O SK, Au GK, Lau JT; Hong Kong Nasopharyngeal Cancer Study Group. Preliminary results of a randomized study on therapeutic gain by concurrent chemotherapy for regionally-advanced nasopharyngeal carcinoma: NPC-9901 Trial by the Hong Kong Nasopharyngeal Cancer Study Group. J Clin Oncol. 2005 Oct 1;23(28):6966-75. doi: 10.1200/JCO.2004.00.7542. |
| 12007936 | Background | Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4. |
| 12829140 | Background | Le QT, Tate D, Koong A, Gibbs IC, Chang SD, Adler JR, Pinto HA, Terris DJ, Fee WE, Goffinet DR. Improved local control with stereotactic radiosurgical boost in patients with nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2003 Jul 15;56(4):1046-54. doi: 10.1016/s0360-3016(03)00117-2. |
| 16377415 | Background | Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037. |
| 11304782 | Background | Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R. Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol. 2001 Apr 15;19(8):2282-92. doi: 10.1200/JCO.2001.19.8.2282. |
| 11290435 | Background | Twelves C, Boyer M, Findlay M, Cassidy J, Weitzel C, Barker C, Osterwalder B, Jamieson C, Hieke K; Xeloda Colorectal Cancer Study Group. Capecitabine (Xeloda) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients with advanced colorectal carcinoma. Eur J Cancer. 2001 Mar;37(5):597-604. doi: 10.1016/s0959-8049(00)00444-5. |
| 12676255 | Background | Chua DT, Sham JS, Au GK. A phase II study of capecitabine in patients with recurrent and metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy. Oral Oncol. 2003 Jun;39(4):361-6. doi: 10.1016/s1368-8375(02)00120-3. |
| Background | Greene FL, et al. AJCC Cancer Staging Handbook from the AJCC cancer staging manual, 6th ed. New York: Springer, 2002. |
| 16904519 | Background | Lee AW, Tung SY, Chan AT, Chappell R, Fu YT, Lu TX, Tan T, Chua DT, O'sullivan B, Xu SL, Pang ES, Sze WM, Leung TW, Kwan WH, Chan PT, Liu XF, Tan EH, Sham JS, Siu L, Lau WH. Preliminary results of a randomized study (NPC-9902 Trial) on therapeutic gain by concurrent chemotherapy and/or accelerated fractionation for locally advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):142-51. doi: 10.1016/j.ijrobp.2006.03.054. |
| Background | Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998. |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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