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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562599
Recruitment Status : Unknown
Verified September 2015 by HU DESHENG, Hubei Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 29, 2015
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
HU DESHENG, Hubei Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: raltitrexed-cisplatin Radiation: Intensity-modulated radiotherapy (IMRT) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Of Induction Chemotherapy Followed by Concurrent Chemoradiotherapy With Raltitrexed-Cisplatin for Patients With Locally Advanced Nasopharyngeal Carcinoma
Study Start Date : August 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: drug:raltitrexed safety and efficacy

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

Radiation: Intensity-modulated radiotherapy (IMRT)



Primary Outcome Measures :
  1. ORR (Objective Response Rate) [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. OS(Overall Survival) [ Time Frame: 2 years ]
  2. TTP(Time To Progression) [ Time Frame: 2 years ]
  3. DCR (Disease Control Rate) [ Time Frame: 6 weeks after induction chemotherapy; 4 weeks and 12 weeks after radiotherapy. ]
  4. QOL(Quality Of Life) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562599


Contacts
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Contact: Guang Han, M.D.; PH.D 13886048178 hg7913@hotmail.com
Contact: Xiaoyi Zhou, M.D. 13995692404 zhouxy1218@sina.com

Locations
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China, Hubei
Hubei Cancer hospital Recruiting
Wu Han, Hubei, China, 430079
Contact: Han Guang, PH.D         
Principal Investigator: Hu Desheng, M.D         
Sponsors and Collaborators
Hubei Cancer Hospital
Investigators
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Principal Investigator: Desheng Hu, M.D. Associate dean
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Responsible Party: HU DESHENG, Associate dean, Hubei Cancer Hospital
ClinicalTrials.gov Identifier: NCT02562599    
Other Study ID Numbers: Radiotherapy center-001
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by HU DESHENG, Hubei Cancer Hospital:
Induction Chemotherapy
Concurrent Chemoradiotherapy
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Raltitrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors