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

NCT02562599 | Completed Phase 2

• 1 other identifier: Radiotherapy center-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Induction Chemotherapy; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR (Objective Response Rate)

  up to 12 weeks

Secondary Outcomes (4)

• OS(Overall Survival)

  2 years

• TTP（Time To Progression）

  2 years

• DCR (Disease Control Rate)

  6 weeks after induction chemotherapy; 4 weeks and 12 weeks after radiotherapy.

• QOL（Quality Of Life）

  2 years

Study Arms (1)

drug:raltitrexed safety and efficacy

EXPERIMENTAL

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)

Drug: raltitrexed-cisplatin; Radiation: Intensity-modulated radiotherapy (IMRT)

Interventions

raltitrexed-cisplatin DRUG

Patients receive raltitrexed-cisplatin neoadjuvant chemotherapy every three weeks for two cycles, then receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles

Also known as: Tomudex

drug:raltitrexed safety and efficacy

Intensity-modulated radiotherapy (IMRT) RADIATION

Patients receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles

drug:raltitrexed safety and efficacy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer hospital

Wuhan, Hubei, 430079, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

raltitrexed; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Desheng Hu, M.D.

  Associate dean

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate dean

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 29, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2018
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)