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

This study is currently recruiting participants.
Verified November 2012 by The First People's Hospital of Lianyungang
Sponsor:
Collaborators:
The East Hospital of Lianyungang
The People's Hospital of Donghai
The People's Hospital of Ganyu
Information provided by (Responsible Party):
The First People's Hospital of Lianyungang
ClinicalTrials.gov Identifier:
NCT01732380
First received: November 14, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The First People's Hospital of Lianyungang:

Primary Outcome Measures:
  • Progression-Free-Survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Response Rate [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 108
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732380

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

Locations
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
The People's Hospital of Donghai
The People's Hospital of Ganyu
Investigators
Study Chair: Xiaodong Jiang, Doctor The First People`s Hospital of Lianyungang
  More Information

Publications:

Responsible Party: The First People's Hospital of Lianyungang
ClinicalTrials.gov Identifier: NCT01732380     History of Changes
Other Study ID Numbers: 1stPeopleLianyungang
Study First Received: November 14, 2012
Last Updated: November 19, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 17, 2014