Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00379262
Other study ID # NPC-0501 Trial
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date December 2018

Study information

Verified date August 2019
Source Hong Kong Nasopharyngeal Cancer Study Group Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this clinical study are threefold:

1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.

2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.

3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.


Description:

1. primary objectives include

1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)

2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)

3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.

2. secondary objectives include

1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)

2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.


Recruitment information / eligibility

Status Completed
Enrollment 803
Est. completion date December 2018
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- histologically proven nasopharyngeal carcinoma for primary treatment with radical intent

- non-keratinizing or undifferentiated type

- stage III-IVB (by AJCC/UICC 6th edition)

- ECOG Performance status less or equal to 2

- Marrow: WBC >= 4 and platelet >=100

- Renal: creatinine clearance >=60

- Informed consent

Exclusion Criteria:

- Primary treatment with palliative intent

- WHO type I squamous cell carcinoma or adenocarcinoma

- Evidence of distant metastases

- Patient is pregnant or lactating

- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Capecitabine
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Adjuvant chemotherapy using PF (5-Fluorouracil )
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)
Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles

Locations

Country Name City State
China Cancer Center, Sun Yat Sen University Guangzhou
China Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital 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

Sponsors (3)

Lead Sponsor Collaborator
Hong Kong Nasopharyngeal Cancer Study Group Limited hong Kong Cancer Fund, The Hong Kong Anti-Cancer Society

Country where clinical trial is conducted

China, 

References & Publications (11)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.

Greene FL, et al. AJCC Cancer Staging Handbook from the AJCC cancer staging manual, 6th ed. New York: Springer, 2002.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year. 5 years
Primary Overall Survival, defined as the time to death due to any cause, at 5-year. 5 years
Secondary overall Failure-Free Rate, defined as time to failure at any site) 5 years
Secondary Loco-regional Failure-Free Rate, defined as time to local or nodal failure) 5 years
Secondary Distant Failure-Free Rate, defined as time to distant failure) 5 years
Secondary Incidence of chemotherapy toxicity and acute RT toxicity grade > 3 treatment
Secondary Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3) 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT05979961 - Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT06055816 - Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma Phase 2
Recruiting NCT05547971 - Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
Not yet recruiting NCT05020925 - SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 1/Phase 2
Not yet recruiting NCT04548271 - Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Not yet recruiting NCT04547088 - Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02795169 - Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02801487 - Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Terminated NCT02569788 - Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma Phase 1/Phase 2
Completed NCT02237924 - Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma Phase 2
Recruiting NCT02044562 - Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients N/A
Terminated NCT01694576 - NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation Phase 2
Recruiting NCT01462903 - A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors Phase 1
Completed NCT01271439 - Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma Phase 2
Completed NCT00535795 - Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA Phase 3
Completed NCT03398980 - Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy N/A
Completed NCT01309633 - Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC) Phase 2
Not yet recruiting NCT05519956 - Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines Phase 3