Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 202 |
Est. completion date | August 2023 |
Est. primary completion date | August 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
China | Lv Xiupeng | Dalian | Liaoning |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Dalian Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS,Progress Free Survival | Progress free survival defined as time from the first day of treatment until disease progress or death | 2 years | |
Secondary | Incidence of Treatment-Emergent Adverse Events | Treatment-Emergent Adverse Event is defined according to CTCAE(Common Terminology Criteria for Adverse Events) v.4.0. All the adverse reactions and serious adverse reactions will be recorded based on laboratory tests, physical examination, ECOG performance status, electrocardiogram and etc. And then will be graded according to CTCAE v.4.0. | 2 years | |
Secondary | OS,Overall Survival | Overall survival was defined as time from diagnosis until either death as a result of any cause. For patients who loss to follow-up before death, defined the last follow-up time as the death time | 2 years | |
Secondary | DCR,Disease Control Rate | according to RECIST criterion, defined as CR(complete response) + PR(partial reponse) + SD(stable disease) | 2 years |
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