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

Brief Title

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

Official Title

Study Of Induction Chemotherapy Followed by Concurrent Chemoradiotherapy With Raltitrexed-Cisplatin for Patients With Locally Advanced Nasopharyngeal Carcinoma

Brief 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.
    

Detailed Description

      Although concurrent chemoradiation is the standard treatment modality for locally advanced
      nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment
      related toxicities have become an obstacle to be overcome. A phase Ⅱ study conducted by Hui
      et al. showed that neoadjuvant chemotherapy followed by concurrent chemoradiotherapy was
      superior to the standard concomitant chemoradiation in terms of the 3-year OS without
      significantly exacerbating the acute toxicities.

      At present, PF regimen has been considered as the most classic chemotherapy regimen of
      nasopharyngeal carcinoma (NPC), but its efficiency is about 40%-60% , and always with severe
      gastrointestinal reactions, renal toxicity and oral mucosa reaction. Therefore, it is
      imperative to find a more safe and effective chemotherapy regimen.

      Raltitrexed is a specific thymidylate synthase inhibitor with a convenient administration
      schedule,acceptable and manageable toxicity, radiosensitising properties. It may offer
      advantages compared with standard 5-FU chemotherapy regimens used in locally advanced NPC.

      Therefore, the investigators initiated this study 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 NPC.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

ORR (Objective Response Rate)

Secondary Outcome

 OS(Overall Survival)

Condition

Nasopharyngeal Carcinoma

Intervention

raltitrexed-cisplatin

Study Arms / Comparison Groups

 drug:raltitrexed safety and efficacy

Description:  To receive the safety and efficacy of raltitrexed-cisplatin neoadjuvant chemotherapy followed by concurrent chemoradiotherapy with raltitrexed-cisplatin
Interventions:
Neochemotherapy (Induction Chemotherapy) Drugs: raltitrexed-cisplatin (Raltitrexed, 2.5mg/m2, IV in 15 minutes, d1; Cisplatin, 25mg/m2, IV, d1-3.Cycled every 21 days for 2 cycles).
Concurrent Chemotherapy Drugs: raltitrexed-cisplatin (Raltitrexed, 2.5mg/m2, IV in 15 minutes, d1; Cisplatin, 25mg/m2, IV, d1-3.Cycled every 21 days for 2 cycles) .
Radiation: Intensity-modulated radiotherapy (IMRT)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

60

Start Date

August 2015

Completion Date

August 2018

Primary Completion Date

August 2016

Eligibility 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
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Desheng Hu, M.D., 13886048178, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT02562599

Organization ID

Radiotherapy center-001

Responsible Party

Principal Investigator

Study Sponsor

Hubei Cancer Hospital

Study Sponsor

Desheng Hu, M.D., Principal Investigator, Associate dean

Verification Date

September 2015