Back to resultsChemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
raltitrexed-cisplatin
Intensity-modulated radiotherapy (IMRT)
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Induction Chemotherapy, Concurrent Chemoradiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO III
- Newly diagnosed T3-4 or any TN2-3 locally advanced nasopharyngeal carcinoma
- At least one measurable lesion (according to the RECIST1.1)
- female and male,18-70 years of age
- ECOG performance status of 0-1
- Life expectancy of more than 3 months
- Without radiotherapy or chemotherapy
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
- Signed and dated informed consent.
Exclusion Criteria:
- Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Evidence of distant metastasis
- 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
- Pregnant or breast-feeding females
- Abuse of psychiatric drugs or dysphrenia
- Prior chemotherapy with raltitrexed or cisplatin
- Allergic to clinical drugs
- Participation in clinical trials for other anti-tumor drugs in 4 weeks
- 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
Sites / Locations
- Hubei Cancer hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
drug:raltitrexed safety and efficacy
Arm 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)
Outcomes
Primary Outcome Measures
ORR (Objective Response Rate)
Secondary Outcome Measures
OS(Overall Survival)
TTP（Time To Progression）
DCR (Disease Control Rate)
QOL（Quality Of Life）
Full Information
NCT ID
NCT02562599
First Posted
September 23, 2015
Last Updated
February 4, 2022
Sponsor
Hubei Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02562599
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hubei Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Induction Chemotherapy, Concurrent Chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drug:raltitrexed safety and efficacy
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
raltitrexed-cisplatin
Other Intervention Name(s)
Tomudex
Intervention Description
Patients receive raltitrexed-cisplatin neoadjuvant chemotherapy every three weeks for two cycles, then receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy (IMRT)
Intervention Description
Patients receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles
Primary Outcome Measure Information:
Title
ORR (Objective Response Rate)
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
OS(Overall Survival)
Time Frame
2 years
Title
TTP（Time To Progression）
Time Frame
2 years
Title
DCR (Disease Control Rate)
Time Frame
6 weeks after induction chemotherapy; 4 weeks and 12 weeks after radiotherapy.
Title
QOL（Quality Of Life）
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO III
Newly diagnosed T3-4 or any TN2-3 locally advanced nasopharyngeal carcinoma
At least one measurable lesion (according to the RECIST1.1)
female and male,18-70 years of age
ECOG performance status of 0-1
Life expectancy of more than 3 months
Without radiotherapy or chemotherapy
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
Signed and dated informed consent.
Exclusion Criteria:
Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Evidence of distant metastasis
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
Pregnant or breast-feeding females
Abuse of psychiatric drugs or dysphrenia
Prior chemotherapy with raltitrexed or cisplatin
Allergic to clinical drugs
Participation in clinical trials for other anti-tumor drugs in 4 weeks
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desheng Hu, M.D.
Organizational Affiliation
Associate dean
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hubei Cancer hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are not enough people participated in the treatment.
Learn more about this trial
Chemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin
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