Clinical trial · Interventional
Benefit of Changing Chemoradiotherapy Sequence and Modifying Radiotherapy Schedule for Advanced Nasopharyngeal Cancer
Randomized Trial to Evaluate the Therapeutic Gain by Changing the Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and the Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
- 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 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 (PF or PX, respectively) 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.
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 Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Accelerated Radiotherapy | Procedure | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Conventional Radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
- 5-year
- measure
- Overall Survival
- timeFrame
- 5-year
Secondary outcomes (3)
- measure
- Overall / Locoregional / Distant Failure Free Rate
- timeFrame
- 5-year
- measure
- Chemotherapy and RT toxicity
- timeFrame
- within 90 day from commencement of RT
- measure
- Late Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven nasopharyngeal carcinoma * Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition) * Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax) * Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated. * Liver scan if SGOT exceeds the institutional upper limit of normal * Adequate marrow: WBC \> 4 and platelet \> 100 * Adequate renal function: creatinine clearance \> 60 ml/min. * Satisfactory performance status: \> 2 by ECOG System. Exclusion Criteria: * WHO Type I squamous cell carcinoma or adenocarcinoma * Age \> 70 * Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique) * 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 five years. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
References
Publications (0)
Data not yet available