Clinical trial · Interventional
Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC.
Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial
NCT03196843CI-TRIAL-00046494unknownPhase 4ClinicalTrials.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 evaluate the efficacy of radiotherapy combine with raltitrexed in older patients with head and neck squamous cell carcinoma.
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity Modulated Radiotherapy | Radiation | — | UNRESOLVED |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Raltitrexed plus Radiation
- description
- Raltitrexed 2.5mg/m2, iv, every 3 weeks, concurrently with intensity modulated radiotherapy(IMRT)
- interventionNames
- Drug: Raltitrexed
- Radiation: Intensity Modulated Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Radiation
- description
- Intensity modulated radiotherapy(IMRT) alone radical radiotherapy:70Gy/2Gy/7 weeks preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 weeks
- interventionNames
- Radiation: Intensity Modulated Radiotherapy
Primary outcomes (1)
- measure
- PFS，Progress Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent. 2. Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx. 3. Ages≥65 years,Not limited to gender. 4. ECOG performance status ≤2. 5. Patients with surgical contraindication or reject to surgery. 6. Postoperative TNM(primary tumor,regional nodes,metastasis) staging III\~IV, positive surgical margin. 7. without evidence of distant metastases. 8. No contraindication to chemoradiotherapy. 9. Life expectancy \> 3 months. 10. Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet\>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) \<1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min Exclusion Criteria: 1. Patients with a history of any other malignancy. 2. Concomitant treatment with any other anticancer therapy. 3. Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)
References
Publications (0)
Data not yet available
No reference posted for this study.