A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
This study has been completed.
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Collaborator:
The Royal Australian and New Zealand College of Radiologists
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00123318
First received: July 19, 2005
Last updated: June 17, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: epirubicin Drug: cisplatin Drug: 5-fluorouracil Radiation: Radiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer |
Resource links provided by NLM:
Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
- The percentage of patients who complete the planned chemoradiation protocol [ Time Frame: Final analysis will be at 3 years. ] [ Designated as safety issue: No ]
- The percentage of major radiotherapy protocol violations [ Time Frame: Final analysis will be at 3 years. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Median survival and overall survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | February 2003 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
|
Drug: epirubicin
50mg/m2 IV day 1
Other Name: Epirubicin Ebewe, Epirubicin Hydrochloride for Injection
Drug: cisplatin
60mg/m2 IV day 1
Other Name: Cisplatin Ebewe, Cisplatin Injection
Drug: 5-fluorouracil
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
Other Name: DBL Fluoruracil Injection BP, Efudix
Radiation: Radiotherapy
45Gy 25 Fractions, 5 days/week for 5 weeks
Other Name: Radiation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00123318
Locations
| Australia, New South Wales | |
| Liverpool Hospital | |
| Liverpool, New South Wales, Australia, 1871 | |
| Calvary Mater Newcastle | |
| Newcastle, New South Wales, Australia, 2298 | |
| Nepean Cancer Care Centre | |
| Penrith, New South Wales, Australia, 2751 | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Westmead Hospital | |
| Sydney, New South Wales, Australia, 2145 | |
| Royal Prince Alfred Hospital | |
| Sydney, New South Wales, Australia, 2050 | |
| Royal North Shore Hospital | |
| Sydney, New South Wales, Australia, 2069 | |
| Australia, Queensland | |
| Mater QRI | |
| Brisbane, Queensland, Australia | |
| Royal Brisbane Hospital | |
| Herston, Queensland, Australia, 4029 | |
| East Coast Cancer Centre | |
| Tugun, Queensland, Australia, 4224 | |
| Princess Alexandra Hospital | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, Tasmania | |
| Launceston General Hospital | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia | |
| Andrew Love Cancer Care Centre, Geelong Hospital | |
| Geelong, Victoria, Australia, 3220 | |
| Austin Health | |
| Melbourne, Victoria, Australia, 3081 | |
| Peter MacCallum Cancer Centre | |
| Melbourne, Victoria, Australia, 8006 | |
| Alfred Hospital | |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Perth, Western Australia, Australia, 6009 | |
| New Zealand | |
| Christchurch Hospital | |
| Christchurch, New Zealand, 4710 | |
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
The Royal Australian and New Zealand College of Radiologists
Investigators
| Study Chair: | Trevor Leong | Peter MacCallum Cancer Centre, Australia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Trans-Tasman Radiation Oncology Group (TROG) |
| ClinicalTrials.gov Identifier: | NCT00123318 History of Changes |
| Other Study ID Numbers: | TROG 03.02 |
| Study First Received: | July 19, 2005 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
|
Gastric cancer Radiotherapy Chemotherapy Chemoradiation |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Adjuvants, Immunologic Cisplatin Epirubicin Fluorouracil |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antibiotics, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents |
ClinicalTrials.gov processed this record on June 17, 2013