Nasopharyngeal CarcinomaPhase 3NCT00379262
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
A Phase 3 study testing Capecitabine, Adjuvant chemotherapy using PF (5-Fluorouracil ) and Induction chemotherapy using PF (5-Fluorouracil) in people with Nasopharyngeal Carcinoma, run by Hong Kong Nasopharyngeal Cancer Study Group Limited at 7 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Capecitabine, Adjuvant chemotherapy using PF (5-Fluorouracil ) and Induction chemotherapy using PF (5-Fluorouracil)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 7 sitesChina
- Study dates
- Sep 2006to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Cancer Center, Sun Yat Sen University
Guangzhou
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
Department of Clinical Oncology, Princess Margaret Hospital
Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong
About this study
Official title: Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
The objectives of this clinical study are threefold:
- 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.
- 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.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
Read the detailed description
- primary objectives include
- comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
- comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
- comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
- secondary objectives include
- comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
- Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Capecitabine, Adjuvant chemotherapy using PF (5-Fluorouracil ), Induction chemotherapy using PF (5-Fluorouracil)
- Keywords
- Nasopharyngeal Carcinoma, Chemoradiotherapy, Accelerated Fractionation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
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
| Study group | Role | What they receive |
|---|---|---|
| 1A | Experimental | Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy Receives: Drug: Adjuvant chemotherapy using PF (5-Fluorouracil ) |
| 1B | Experimental | Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy Receives: Drug: Adjuvant chemotherapy using PF (5-Fluorouracil ) |
| 2A | Experimental | Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy Receives: Drug: Induction chemotherapy using PF (5-Fluorouracil) |
| 2B | Experimental | Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy Receives: Drug: Induction chemotherapy using PF (5-Fluorouracil) |
| 3A | Experimental | Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy Receives: Drug: Capecitabine |
| 3B | Experimental | Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Measured: 5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
Measured: 5 years
Secondary outcomes (5)
overall Failure-Free Rate, defined as time to failure at any site)
Measured: 5 years
Loco-regional Failure-Free Rate, defined as time to local or nodal failure)
Measured: 5 years
Distant Failure-Free Rate, defined as time to distant failure)
Measured: 5 years
Incidence of chemotherapy toxicity and acute RT toxicity grade > 3
Measured: treatment
Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Nasopharyngeal Cancer Study Group Limited
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Anti-Cancer Society, hong Kong Cancer Fund
- Responsible party
- Principal investigator, Dr. ANNE W M LEE, Hong Kong Nasopharyngeal Cancer Study Group Limited
- Investigators
- Anne W.M. Lee, F.R.C.R., Principal investigator, Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong KongRoger K.C. Ngan, F.R.C.R, Principal investigator, Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379262
- Sponsor's protocol ID
- NPC-0501 Trial
- Status last verified
- Aug 2019
- First submitted
- 20 Sep 2006
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9552031Lee 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.
PubMed 16192584Lee 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.
PubMed 12007936Le 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.
PubMed 12829140Baujat 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.
PubMed 16377415Hoff 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.
PubMed 11304782Twelves 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.
PubMed 11290435Chua 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.
PubMed 12676255Greene FL, et al. AJCC Cancer Staging Handbook from the AJCC cancer staging manual, 6th ed. New York: Springer, 2002.
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.
PubMed 16904519Freedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00379262
- Acronym / sponsor ID
- NPC-0501 Trial
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Chemoradiotherapy, Accelerated Fractionation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Hong Kong Nasopharyngeal Cancer Study Group LimitedUniversity, hospital or other
- Collaborators
- The Hong Kong Anti-Cancer Society, hong Kong Cancer Fund
- Study start
- Sep 2006
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this clinical study are threefold:
- 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.
- 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.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
Detailed description
- primary objectives include
- comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
- comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
- comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
- secondary objectives include
- comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
- Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1A | Experimental | Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy |
| 1B | Experimental | Drug: Adjuvant chemotherapy using PF (5-Fluorouracil )Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy |
| 2A | Experimental | Drug: Induction chemotherapy using PF (5-Fluorouracil)Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy |
| 2B | Experimental | Drug: Induction chemotherapy using PF (5-Fluorouracil)Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy |
| 3A | Experimental | Drug: CapecitabineInduction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy |
| 3B | Experimental | Drug: CapecitabineInduction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaDose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles | Drug | 3A, 3B |
| 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 | Drug | 1A, 1B |
| 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 | Drug | 2A, 2B |
Primary outcome
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Time frame: 5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
Time frame: 5 years
5 secondary outcomes
overall Failure-Free Rate, defined as time to failure at any site)
Time frame: 5 years
Loco-regional Failure-Free Rate, defined as time to local or nodal failure)
Time frame: 5 years
Distant Failure-Free Rate, defined as time to distant failure)
Time frame: 5 years
Incidence of chemotherapy toxicity and acute RT toxicity grade > 3
Time frame: treatment
Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 9552031Al-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.
- Background: PubMed 16192584Lee 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.
- Background: PubMed 12007936Lee 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.
- Background: PubMed 12829140Le 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.
- Background: PubMed 16377415Baujat 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.
- Background: PubMed 11304782Hoff 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.
- Background: PubMed 11290435Twelves 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.
- Background: PubMed 12676255Chua 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.
- BackgroundGreene FL, et al. AJCC Cancer Staging Handbook from the AJCC cancer staging manual, 6th ed. New York: Springer, 2002.
- Background: PubMed 16904519Lee 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.
- BackgroundFreedman J, Furberg, C, DeMets D. Fundamentals of clinical trials. Springer-Verlag, NY, 1998.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne W.M. Lee, F.R.C.R. principal investigator
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Roger K.C. Ngan, F.R.C.R principal investigator
Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine, Adjuvant chemotherapy using PF (5-Fluorouracil ) and Induction chemotherapy using PF (5-Fluorouracil) in people with Nasopharyngeal Carcinoma, run by Hong Kong Nasopharyngeal Cancer Study Group Limited at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379262, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.