Clinical trial · Interventional
Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic 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 purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional chemotherapy | Drug | — | UNRESOLVED |
| Maintenance chemotherapy 1 | Drug | — | UNRESOLVED |
| Maintenance chemotherapy 2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Conventional chemotherapy
- description
- Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.
- interventionNames
- Drug: Conventional chemotherapy
- type
- EXPERIMENTAL
- label
- Maintenance chemotherapy 1
- description
- Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.
- interventionNames
- Drug: Conventional chemotherapy
- Drug: Maintenance chemotherapy 1
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 and ≤ 70 years * Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III * With distant metastasis * With measurable lesions that can be detected by imaging studies * Achieving PR (partial response) after 4 cycles of conventional chemotherapy * Life expectancy ≥ 6 months * ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses * Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT (platelet count) \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) \< 1.5 ULN (upper limit of normal); SCr (serum creatinine) \< 1.5mg/dl; CCR (creatinine clearance rate) \> 60ml/min * Willing to accept adequate contraception for women with childbearing potential * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * Received previous treatment for metastatic disease * Pregnant or lactating women * A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years * Refusal of the patient to participate into the study
References
Publications (0)
Data not yet available