Clinical trial NCT02562599: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Induction Chemotherapy
Concurrent Chemoradiotherapy
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: ORR (Objective Response Rate)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: OS(Overall Survival)
timeFrame: 2 years
measure: TTP（Time To Progression）
timeFrame: 2 years
measure: DCR (Disease Control Rate)
timeFrame: 6 weeks after induction chemotherapy; 4 weeks and 12 weeks after radiotherapy.
measure: QOL（Quality Of Life）
timeFrame: 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer hospital
state: Hubei
Study officials:
affiliation: Associate dean
name: Desheng Hu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: