A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

NCT ID: NCT00123318

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2012-02-29

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

epirubicin

Intervention Type: DRUG

50mg/m2 IV day 1

cisplatin

Intervention Type: DRUG

60mg/m2 IV day 1

5-fluorouracil

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

45Gy 25 Fractions, 5 days/week for 5 weeks

Interventions

epirubicin

50mg/m2 IV day 1

Intervention Type: DRUG

cisplatin

60mg/m2 IV day 1

Intervention Type: 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

Intervention Type: DRUG

Radiotherapy

45Gy 25 Fractions, 5 days/week for 5 weeks

Intervention Type: RADIATION

Other Intervention Names

Epirubicin Ebewe, Epirubicin Hydrochloride for Injection; Cisplatin Ebewe, Cisplatin Injection; DBL Fluoruracil Injection BP, Efudix; Radiation

Eligibility Criteria

Inclusion Criteria

All of the following must apply:

• Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:

1. completely resected with negative margins

2. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Royal Australian and New Zealand College of Radiologists

OTHER

Sponsor Role: collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trevor Leong

Role: STUDY_CHAIR

Peter MacCallum Cancer Centre, Australia

Locations

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Nepean Cancer Care Centre

Penrith, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Sydney, New South Wales, Australia

Mater QRI

Brisbane, Queensland, Australia

Royal Brisbane Hospital

Herston, Queensland, Australia

East Coast Cancer Centre

Tugun, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Launceston General Hospital

Launceston, Tasmania, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Andrew Love Cancer Care Centre, Geelong Hospital

Geelong, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Alfred Hospital

Prahran, Victoria, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Christchurch Hospital

Christchurch, , New Zealand

Countries

Australia; New Zealand

Related Links

http://www.trog.com.au

Click here for more information about this study on the TROG official website

Other Identifiers

TROG 03.02

Identifier Type: -

Identifier Source: org_study_id