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.
Radiotherapy play a critical role in the treatment of head and neck squamous cell carcinoma.
Concurrent chemoradiotherapy can increased patients' survival rate. Most of head and neck
squamous cell carcinoma patients are in the age range from 60 to 80 years old. Head and neck
cancer begin in concealed anatomic sites that make it difficult to found the disease.
Therefore, a larger proportion of patients diagnosed with cancer at a late stage.The tissues
of head and neck are closely related to important functions such as respiratory, swallowing.
Therefore patients are often accompanied by poor nutritional status, cardiac dysfunction and
other chronic diseases.Since the tumor is extensive and it cannot be completely
resected.These patients are not suitable for surgery alone. Radical radiotherapy or adjuvant
radiotherapy is often administered. In order to increase the treatment efficacy, patients
with high risk are commonly treated with concurrent chemoradiotherapy. Concurrent
chemoradiotherapy often cause serious side effects. For older patients who often have chronic
health conditions or poor ECOG(Eastern Cooperative Oncology Group) score are difficult to
tolerate.It is crucial to enhance the efficacy of treatment of head and neck squamous cell
carcinoma in older patients without causing significant side effect.
Raltitrexed is a direct and specific thymidylate synthase (TS) inhibitor and it is an
alternative option for patients unsuitable for cisplatin based chemoradiotherapy. It is more
suitable for the treatment of head and neck squamous cell carcinoma in older patients. It is
deserved to further investigation. Researches indicated that raltitrexed has shown efficacy
and good safety profile in the treatment of colorectal cancer.
It is rarely reported that intensity modulated radiotherapy plus raltitrexed in the treatment
of patients with head and neck squamous cell carcinoma,particularly in older patients.The aim
of this study was to compare the efficacy of intensity modulated radiotherapy plus
raltitrexed with intensity modulated radiotherapy alone in older patients with squamous cell
carcinoma of the head and neck.
According to EORTC(European Organization for Research on Treatment of Cancer)22931 study, The
2-year PFS(progression-free survival) was 48% with chemotherapy alone in squamous cell
carcinoma of the head and neck. Planting A et al studied raltitrexed at escalating doses
combine with radiotherapy in locally advanced head and neck cancer. The results showed that
12 out of 17 patients remained free of locoregional recurrence after a median follow-up of
24(+) months (range 3-60+ months).The study was designed to detect a 15-20% clinic benefit
for patients, using α of 0.05 and a β of 0.20. To achieve this, the number of patients
required was 101 per group, according to drup-out rate 10%.
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