Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With HNSCC.

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196843
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lv Xiupeng, The First Affiliated Hospital of Dalian Medical University

Brief Summary:
The purpose of this study is to evaluate the efficacy of radiotherapy combine with raltitrexed in older patients with head and neck squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Drug: Raltitrexed Radiation: Intensity Modulated Radiotherapy Phase 4

Detailed Description:

Radiotherapy play a critical role in the treatment of head and neck squamous cell carcinoma. Concurrent chemoradiotherapy can increased patients' survival rate. Most of head and neck squamous cell carcinoma patients are in the age range from 60 to 80 years old. Head and neck cancer begin in concealed anatomic sites that make it difficult to found the disease. Therefore, a larger proportion of patients diagnosed with cancer at a late stage.The tissues of head and neck are closely related to important functions such as respiratory, swallowing. Therefore patients are often accompanied by poor nutritional status, cardiac dysfunction and other chronic diseases.Since the tumor is extensive and it cannot be completely resected.These patients are not suitable for surgery alone. Radical radiotherapy or adjuvant radiotherapy is often administered. In order to increase the treatment efficacy, patients with high risk are commonly treated with concurrent chemoradiotherapy. Concurrent chemoradiotherapy often cause serious side effects. For older patients who often have chronic health conditions or poor ECOG(Eastern Cooperative Oncology Group) score are difficult to tolerate.It is crucial to enhance the efficacy of treatment of head and neck squamous cell carcinoma in older patients without causing significant side effect.

Raltitrexed is a direct and specific thymidylate synthase (TS) inhibitor and it is an alternative option for patients unsuitable for cisplatin based chemoradiotherapy. It is more suitable for the treatment of head and neck squamous cell carcinoma in older patients. It is deserved to further investigation. Researches indicated that raltitrexed has shown efficacy and good safety profile in the treatment of colorectal cancer.

It is rarely reported that intensity modulated radiotherapy plus raltitrexed in the treatment of patients with head and neck squamous cell carcinoma,particularly in older patients.The aim of this study was to compare the efficacy of intensity modulated radiotherapy plus raltitrexed with intensity modulated radiotherapy alone in older patients with squamous cell carcinoma of the head and neck.

According to EORTC(European Organization for Research on Treatment of Cancer)22931 study, The 2-year PFS(progression-free survival) was 48% with chemotherapy alone in squamous cell carcinoma of the head and neck. Planting A et al studied raltitrexed at escalating doses combine with radiotherapy in locally advanced head and neck cancer. The results showed that 12 out of 17 patients remained free of locoregional recurrence after a median follow-up of 24(+) months (range 3-60+ months).The study was designed to detect a 15-20% clinic benefit for patients, using α of 0.05 and a β of 0.20. To achieve this, the number of patients required was 101 per group, according to drup-out rate 10%.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Raltitrexed plus Radiation
Raltitrexed 2.5mg/m2, iv, every 3 weeks, concurrently with intensity modulated radiotherapy(IMRT)
Drug: Raltitrexed
Raltitrexed 2.5mg/m2 on day 1,22,43 during radiotherapy

Radiation: Intensity Modulated Radiotherapy
Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week

Active Comparator: Radiation
Intensity modulated radiotherapy(IMRT) alone radical radiotherapy:70Gy/2Gy/7 weeks preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 weeks
Radiation: Intensity Modulated Radiotherapy
Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week




Primary Outcome Measures :
  1. PFS,Progress Free Survival [ Time Frame: 2 years ]
    Progress free survival defined as time from the first day of treatment until disease progress or death


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 years ]
    Treatment-Emergent Adverse Event is defined according to CTCAE(Common Terminology Criteria for Adverse Events) v.4.0. All the adverse reactions and serious adverse reactions will be recorded based on laboratory tests, physical examination, ECOG performance status, electrocardiogram and etc. And then will be graded according to CTCAE v.4.0.

  2. OS,Overall Survival [ Time Frame: 2 years ]
    Overall survival was defined as time from diagnosis until either death as a result of any cause. For patients who loss to follow-up before death, defined the last follow-up time as the death time

  3. DCR,Disease Control Rate [ Time Frame: 2 years ]
    according to RECIST criterion, defined as CR(complete response) + PR(partial reponse) + SD(stable disease)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.
  2. Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.
  3. Ages≥65 years,Not limited to gender.
  4. ECOG performance status ≤2.
  5. Patients with surgical contraindication or reject to surgery.
  6. Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV, positive surgical margin.
  7. without evidence of distant metastases.
  8. No contraindication to chemoradiotherapy.
  9. Life expectancy > 3 months.
  10. Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) <1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min

Exclusion Criteria:

  1. Patients with a history of any other malignancy.
  2. Concomitant treatment with any other anticancer therapy.
  3. Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)

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): NCT03196843


Contacts
Layout table for location contacts
Contact: Xiupeng Lv, M.D. +86-18098876707 lvxiupeng@foxmail.com

Locations
Layout table for location information
China, Liaoning
Lv Xiupeng Recruiting
Dalian, Liaoning, China, 116000
Contact: Xiupeng Lv, M.D.    18098876707    lvxiupeng@foxmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University

Layout table for additonal information
Responsible Party: Lv Xiupeng, Professor, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03196843    
Other Study ID Numbers: LCKY2016-65
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lv Xiupeng, The First Affiliated Hospital of Dalian Medical University:
raltitrexed
radiotherapy
older patient
head and neck squamous cell carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Raltitrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors