A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: epirubicin; Drug: cisplatin; Drug: 5-fluorouracil; Radiation: Radiotherapy

• Registration Number: NCT00123318
• Lead Sponsor: Trans Tasman Radiation Oncology Group

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Radiotherapy	Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
1	epirubicin	Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
1	cisplatin	Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
1	5-fluorouracil	Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)

Primary Outcome Measures

Name	Time	Method
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity	Final analysis will be at 3 years.
The percentage of patients who complete the planned chemoradiation protocol	Final analysis will be at 3 years.
The percentage of major radiotherapy protocol violations	Final analysis will be at 3 years.

Secondary Outcome Measures

Name	Time	Method
Median survival and overall survival at 3 years	3 years

Trial Locations

Locations (19)

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 Sydney, New South Wales, Australia

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia

Launceston General Hospital; 🇦🇺 Launceston, Tasmania, Australia

East Coast Cancer Centre; 🇦🇺 Tugun, Queensland, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Alfred Hospital; 🇦🇺 Prahran, Victoria, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Andrew Love Cancer Care Centre, Geelong Hospital; 🇦🇺 Geelong, Victoria, Australia

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Calvary Mater Newcastle; 🇦🇺 Newcastle, New South Wales, Australia

Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

Nepean Cancer Care Centre; 🇦🇺 Penrith, New South Wales, Australia

Mater QRI; 🇦🇺 Brisbane, Queensland, Australia

Austin Health; 🇦🇺 Melbourne, Victoria, Australia