Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC.

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University
• Treatments: Raltitrexed

Criteria

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)