Overview

Chemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin

Status:
Unknown status

Trial end date:
2018-08-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin in patients with locally advanced nasopharyngeal carcinoma.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hubei Cancer Hospital

Treatments:

Cisplatin
Raltitrexed

Criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO
III

2. Newly diagnosed T3-4 or any TN2-3 locally advanced nasopharyngeal carcinoma

3. At least one measurable lesion (according to the RECIST1.1)

4. female and male,18-70 years of age

5. ECOG performance status of 0-1

6. Life expectancy of more than 3 months

7. Without radiotherapy or chemotherapy

8. Adequate organ function including the following:

Platelets count >= 100 * 109/l Absolute neutrophil count (ANC) >= 2.0 * 109/l
Hemoglobin >= 90 g/l Total bilirubin <= 1.5ULN AST and ALT <= 2.5ULN,if there is liver
metastasis , AST and ALT <= 5ULN Serum creatine <= 1.5ULN

9. Signed and dated informed consent.

Exclusion Criteria:

1. Before or at the same time any second malignancies except cured basal cell carcinoma
of skin and carcinoma in-situ of uterine cervix

2. Evidence of distant metastasis

3. Taboos of chemotherapy or radiotherapy(such as heart failure, angina pectoris, or
cardiac arrhythmia.et al) Presence of an uncontrolled concomitant illness including,
but not limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, or cardiac arrhythmia

4. Pregnant or breast-feeding females

5. Abuse of psychiatric drugs or dysphrenia

6. Prior chemotherapy with raltitrexed or cisplatin

7. Allergic to clinical drugs

8. Participation in clinical trials for other anti-tumor drugs in 4 weeks

9. Evidence of significant medical illness that in the investigator's judgment will
substantially increase the risk associated with the subject's participation in and
completion of the study