Clinical trial · Interventional
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
NCT03175939CI-TRIAL-00027970completedPhase 2ClinicalTrials.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)
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.
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 Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCRT alone
- description
- External beam radiotherapy \> 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
- interventionNames
- Radiation: Radiotherapy
- Drug: Cisplatin
- Drug: 5-FU
Primary outcomes (1)
- measure
- Distant-metastasis-free survival
- timeFrame
- 5 years
- description
- percentage of patients who survived and has no distant metastasis
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * (1) biopsy-proven carcinoma of the nasopharynx, * (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease, * (3) normal renal function (Cr \< 1.6 mg/dl), Exclusion Criteria: * open-neck lymph node biopsy * previous chemotherapy or radiotherapy to the head and neck region * distant metastasis or other malignant diseases except skin cancer
References
Publications (0)
Data not yet available
No reference posted for this study.