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

Primary Purpose

Inoperable Esophageal Cancer Stage I-III

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
Oxaliplatin
Radiotherapy
Sponsored by
The First People's Hospital of Lianyungang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inoperable Esophageal Cancer Stage I-III

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First People's Hospital of LianyungangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiotherapy

Raltitrexed/Oxaliplatin Plus Radiotherapy

Arm Description

Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer

Outcomes

Primary Outcome Measures

Progression-Free-Survival
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
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.

Full Information

First Posted
November 14, 2012
Last Updated
November 19, 2012
Sponsor
The First People's Hospital of Lianyungang
Collaborators
The East Hospital of Lianyungang, Donghai People's Hospital, People's Hospital of Ganyu
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1. Study Identification

Unique Protocol Identification Number
NCT01732380
Brief Title
A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Official Title
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First People's Hospital of Lianyungang
Collaborators
The East Hospital of Lianyungang, Donghai People's Hospital, People's Hospital of Ganyu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inoperable Esophageal Cancer Stage I-III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Arm Title
Raltitrexed/Oxaliplatin Plus Radiotherapy
Arm Type
Experimental
Arm Description
Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Other Intervention Name(s)
TOMUDEX, Sai Wei Jian
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Progression-Free-Survival
Description
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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Response Rate
Description
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.
Time Frame
up to 2 years
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Jiang, Doctor
Phone
86-0518-85469074
Email
jxdysy1970@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Jiang, Doctor
Organizational Affiliation
The First People's Hospital of Lianyungang
Official's Role
Study Chair
Facility Information:
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Jiang, Doctor
Email
jxdysy1970@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
20645400
Citation
Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.
Results Reference
background
PubMed Identifier
17329193
Citation
Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.
Results Reference
background
PubMed Identifier
20839062
Citation
McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.
Results Reference
background
PubMed Identifier
12176786
Citation
Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.
Results Reference
background
PubMed Identifier
12075739
Citation
Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
Results Reference
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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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