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A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
epirubicin
cisplatin
5-fluorouracil
Radiotherapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Radiotherapy, Chemotherapy, Chemoradiation

Eligibility Criteria

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

Inclusion Criteria: All of the following must apply: Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is: completely resected with negative margins Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician. Age greater than or equal to 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 Adequate organ function defined as follows: Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to 100 x 10^9 /L Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN; Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min. Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment. Disease which can be radically treated to 45 Gy with standard fractionation. Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy. Written informed consent Exclusion Criteria: None of the following must apply: Evidence of metastatic disease. Prior chemotherapy or radiotherapy Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled. Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures. Cardiac failure (relevant to the use of epirubicin): Patients with myocardial infarction within the last 6 months; Patients with New York Heart Association class III/IV congestive heart failure

Sites / Locations

  • Liverpool Hospital
  • Calvary Mater Newcastle
  • Nepean Cancer Care Centre
  • Prince of Wales Hospital
  • Royal Prince Alfred Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Mater QRI
  • Royal Brisbane Hospital
  • East Coast Cancer Centre
  • Princess Alexandra Hospital
  • Launceston General Hospital
  • Box Hill Hospital
  • Andrew Love Cancer Care Centre, Geelong Hospital
  • Austin Health
  • Peter MacCallum Cancer Centre
  • Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Christchurch Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)

Outcomes

Primary Outcome Measures

The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
The percentage of patients who complete the planned chemoradiation protocol
The percentage of major radiotherapy protocol violations

Secondary Outcome Measures

Median survival and overall survival at 3 years

Full Information

First Posted
July 19, 2005
Last Updated
June 17, 2013
Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
The Royal Australian and New Zealand College of Radiologists
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1. Study Identification

Unique Protocol Identification Number
NCT00123318
Brief Title
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Official Title
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group
Collaborators
The Royal Australian and New Zealand College of Radiologists

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the side-effects and effectiveness of a new type of chemoradiotherapy treatment for patients who have had surgery for stomach cancer. The treatment uses epirubicin, cisplatin, and 5-fluorouracil (ECF) chemotherapy together with radiotherapy.
Detailed Description
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques. The specific objectives of the study are: To detail the acute toxicity associated with this treatment. To determine the feasibility of the proposed concurrent chemoradiation regimen. To determine the feasibility of a standardized technique for radiation treatment planning and delivery. The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Radiotherapy, Chemotherapy, Chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
Intervention Type
Drug
Intervention Name(s)
epirubicin
Other Intervention Name(s)
Epirubicin Ebewe, Epirubicin Hydrochloride for Injection
Intervention Description
50mg/m2 IV day 1
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
Cisplatin Ebewe, Cisplatin Injection
Intervention Description
60mg/m2 IV day 1
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
DBL Fluoruracil Injection BP, Efudix
Intervention Description
5-FU 200mg/m2/d IV 21 day continuous infusion Cont. infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiation
Intervention Description
45Gy 25 Fractions, 5 days/week for 5 weeks
Primary Outcome Measure Information:
Title
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Time Frame
Final analysis will be at 3 years.
Title
The percentage of patients who complete the planned chemoradiation protocol
Time Frame
Final analysis will be at 3 years.
Title
The percentage of major radiotherapy protocol violations
Time Frame
Final analysis will be at 3 years.
Secondary Outcome Measure Information:
Title
Median survival and overall survival at 3 years
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the following must apply: Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is: completely resected with negative margins Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician. Age greater than or equal to 18 years Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 Adequate organ function defined as follows: Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to 100 x 10^9 /L Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN; Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min. Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment. Disease which can be radically treated to 45 Gy with standard fractionation. Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy. Written informed consent Exclusion Criteria: None of the following must apply: Evidence of metastatic disease. Prior chemotherapy or radiotherapy Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled. Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures. Cardiac failure (relevant to the use of epirubicin): Patients with myocardial infarction within the last 6 months; Patients with New York Heart Association class III/IV congestive heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor Leong
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Study Chair
Facility Information:
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Nepean Cancer Care Centre
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2069
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Mater QRI
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
East Coast Cancer Centre
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Andrew Love Cancer Care Centre, Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
4710
Country
New Zealand

12. IPD Sharing Statement

Links:
URL
http://www.trog.com.au
Description
Click here for more information about this study on the TROG official website

Learn more about this trial

A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

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