Clinical trial · Interventional
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
NCT00677118CI-TRIAL-00011342unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cisplatin,fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Concurrent and adjuvant
- description
- Concurrent chemoradiotherapy plus adjuvant chemotherapy
- interventionNames
- Drug: Cisplatin,fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- Concurrent
- description
- Concurrent chemoradiotherapy
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Failure-free survival
- timeFrame
- 2-yr
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type) 2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system) 3. No evidence of distant metastasis (M0) 4. Performance status: KPS ≥70 5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal) 6. Renal: creatinine clearance ≥60ml/min 7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL 8. Written informed consent Exclusion Criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age ≥70 or \<18 3. With a history of renal disease 4. Prior malignancy 5. Previous chemotherapy or radiotherapy 6. Patient is pregnant or lactating 7. Unstable cardiac disease requiring treatment. 8. Emotion disturbance
References
Publications (14)
- BACKGROUNDChua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80. doi: 10.1002/cncr.11485. PMID 12833458
- BACKGROUNDMa J, Mai HQ, Hong MH, Cui NJ, Lu TX, Lu LX, Mo HY, Min HQ. Is the 1997 AJCC staging system for nasopharyngeal carcinoma prognostically useful for Chinese patient populations? Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1181-9. doi: 10.1016/s0360-3016(01)01537-1. PMID 11483327
- BACKGROUNDZhao C, Han F, Lu LX, Huang SM, Lin CG, Deng XW, Lu TX, Cui NJ. [Intensity modulated radiotherapy for local-regional advanced nasopharyngeal carcinoma]. Ai Zheng. 2004 Nov;23(11 Suppl):1532-7. Chinese. PMID 15566674
- BACKGROUNDLee 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. PMID 12007936
- BACKGROUNDKam MK, Teo PM, Chau RM, Cheung KY, Choi PH, Kwan WH, Leung SF, Zee B, Chan AT. Treatment of nasopharyngeal carcinoma with intensity-modulated radiotherapy: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1440-50. doi: 10.1016/j.ijrobp.2004.05.022. PMID 15590175
- BACKGROUNDDecker DA, Drelichman A, Al-Sarraf M, Crissman J, Reed ML. Chemotherapy for nasopharyngeal carcinoma. A ten-year experience. Cancer. 1983 Aug 15;52(4):602-5. doi: 10.1002/1097-0142(19830815)52:43.0.co;2-6. PMID 6683121
- BACKGROUNDAl-Sarraf M. Chemotherapeutic management of head and neck cancer. Cancer Metastasis Rev. 1987;6(3):181-98. doi: 10.1007/BF00144263. PMID 3319271