Gastric CancerPhase 3NCT00123318
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
A Phase 3 study testing epirubicin, cisplatin and 5-fluorouracil in people with Gastric Cancer, run by Trans Tasman Radiation Oncology Group at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- epirubicin, cisplatin and 5-fluorouracil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Feb 2003to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Australia18 sites
Box Hill Hospital
Box Hill, Victoria
Mater QRI
Brisbane, Queensland
Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, 3220
Royal Brisbane Hospital
Herston, Queensland, 4029
Launceston General Hospital
Launceston, Tasmania, 7250
Liverpool Hospital
Liverpool, New South Wales, 1871
Austin Health
Melbourne, Victoria, 3081
Peter MacCallum Cancer Centre
Melbourne, Victoria, 8006
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
Nepean Cancer Care Centre
Penrith, New South Wales, 2751
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Alfred Hospital
Prahran, Victoria, 3181
Prince of Wales Hospital
Randwick, New South Wales, 2031
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Royal North Shore Hospital
Sydney, New South Wales, 2069
Westmead Hospital
Sydney, New South Wales, 2145
East Coast Cancer Centre
Tugun, Queensland, 4224
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- epirubicin, cisplatin, 5-fluorouracil, Radiotherapy
- Keywords
- Gastric cancer, Radiotherapy, Chemotherapy, Chemoradiation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epirubicinDrug
Also called Epirubicin Ebewe, Epirubicin Hydrochloride for Injection
50mg/m2 IV day 1
cisplatinDrug
Also called Cisplatin Ebewe, Cisplatin Injection
60mg/m2 IV day 1
5-fluorouracilDrug
Also called DBL Fluoruracil Injection BP, Efudix
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
RadiotherapyRadiation
Also called Radiation
45Gy 25 Fractions, 5 days/week for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy) Receives: Drug: epirubicin; Drug: cisplatin; Drug: 5-fluorouracil; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Measured: Final analysis will be at 3 years.
The percentage of patients who complete the planned chemoradiation protocol
Measured: Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations
Measured: Final analysis will be at 3 years.
Secondary outcomes (1)
Median survival and overall survival at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startFeb 2003
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Australian and New Zealand College of Radiologists
- Responsible party
- Sponsor
- Investigators
- Trevor Leong, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123318
- Sponsor's protocol ID
- TROG 03.02
- Status last verified
- Jun 2013
- First submitted
- 19 Jul 2005
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT00123318
- Acronym / sponsor ID
- TROG 03.02
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Radiotherapy, Chemotherapy, Chemoradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Collaborators
- The Royal Australian and New Zealand College of Radiologists
- Study start
- Feb 2003
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: epirubicin, Drug: cisplatin, Drug: 5-fluorouracil, Radiation: RadiotherapySingle-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Adequate organ function defined as follows:
- Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment.
Key exclusion criteria (8 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epirubicinAlso: Epirubicin Ebewe, Epirubicin Hydrochloride for Injection50mg/m2 IV day 1 | Drug | 1 |
| cisplatinAlso: Cisplatin Ebewe, Cisplatin Injection60mg/m2 IV day 1 | Drug | 1 |
| 5-fluorouracilAlso: DBL Fluoruracil Injection BP, Efudix5-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 | Drug | 1 |
| RadiotherapyAlso: Radiation45Gy 25 Fractions, 5 days/week for 5 weeks | Radiation | 1 |
Primary outcome
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.
The percentage of patients who complete the planned chemoradiation protocol
Time frame: Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations
Time frame: Final analysis will be at 3 years.
1 secondary outcome
Median survival and overall survival at 3 years
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Click here for more information about this study on the TROG official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor Leong study chair
Peter MacCallum Cancer Centre, Australia
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epirubicin, cisplatin and 5-fluorouracil in people with Gastric Cancer, run by Trans Tasman Radiation Oncology Group at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2013.