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A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01732380
Recruitment Status : Unknown
Verified November 2012 by The First People's Hospital of Lianyungang.
Recruitment status was:  Recruiting
First Posted : November 22, 2012
Last Update Posted : November 22, 2012
Sponsor:
Collaborators:
The East Hospital of Lianyungang
Donghai People's Hospital
People's Hospital of Ganyu
Information provided by (Responsible Party):
The First People's Hospital of Lianyungang

Study Description
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Brief Summary:
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.

Condition or disease Intervention/treatment Phase
Inoperable Esophageal Cancer Stage I-III Drug: Raltitrexed Drug: Oxaliplatin Radiation: Radiotherapy Phase 2

Detailed Description:
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Radiotherapy
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
 Radiation: Radiotherapy
Experimental: Raltitrexed/Oxaliplatin Plus Radiotherapy
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
 Drug: Raltitrexed
Other Names:
  • TOMUDEX
  • Sai Wei Jian

Drug: Oxaliplatin
Other Name: Eloxatin

Radiation: Radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free-Survival [ Time Frame: up to 2 years ]
    Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: up to 2 years ]
    Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.


Other Outcome Measures:
  1. Overall survival [ Time Frame: up to 2 years ]
    People in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer. The overall survival is often stated as a five-year survival, which means people in a study or treatment group who are alive five years after their diagnosis or the start of treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
  • Measurable disease according to RECIST criteria
  • Age > 18 years
  • WHO performance score < 2
  • Estimated life expectancy of > 12 weeks
  • Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
  • Renal function: Cr ≤ 1.25×UNL
  • Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
  • Documented informed consent to participate in the trial

Exclusion Criteria:

  • Subjects with distant metastases
  • Pregnancy or breast feeding. Women of childbearing age must use effective contraception
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Evidence of bleeding diathesis or serious infection
  • pregnant or lactating woman
  • Patient participation in other studies
Contacts and Locations
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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): NCT01732380


Contacts
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Contact: Xiaodong Jiang, Doctor 86-0518-85469074 jxdysy1970@163.com

Locations
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China, Jiangsu
The First People`s Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Xiaodong Jiang, Doctor       jxdysy1970@163.com   
Sponsors and Collaborators
The First People's Hospital of Lianyungang
The East Hospital of Lianyungang
Donghai People's Hospital
People's Hospital of Ganyu
Investigators
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Study Chair: Xiaodong Jiang, Doctor The First People`s Hospital of Lianyungang
More Information
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Publications:

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Responsible Party: The First People's Hospital of Lianyungang
ClinicalTrials.gov Identifier: NCT01732380     History of Changes
Other Study ID Numbers: 1stPeopleLianyungang
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Oxaliplatin
Raltitrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors