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A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Information source: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Cancer

Intervention: epirubicin (Drug); cisplatin (Drug); 5-fluorouracil (Drug); Radiotherapy (Radiation)

Phase: Phase 3

Status: Completed

Sponsored by: Trans-Tasman Radiation Oncology Group (TROG)

Official(s) and/or principal investigator(s):
Trevor Leong, Study Chair, Affiliation: Peter MacCallum Cancer Centre, Australia

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.

Clinical Details

Official title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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: Median survival and overall survival at 3 years

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Christchurch Hospital, Christchurch 4710, New Zealand

Liverpool Hospital, Liverpool, New South Wales 1871, Australia

Calvary Mater Newcastle, Newcastle, New South Wales 2298, Australia

Nepean Cancer Care Centre, Penrith, New South Wales 2751, Australia

Prince of Wales Hospital, Randwick, New South Wales 2031, Australia

Royal North Shore Hospital, Sydney, New South Wales 2069, Australia

Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia

Westmead Hospital, Sydney, New South Wales 2145, Australia

Mater QRI, Brisbane, Queensland, Australia

Royal Brisbane Hospital, Herston, Queensland 4029, Australia

East Coast Cancer Centre, Tugun, Queensland 4224, Australia

Princess Alexandra Hospital, Woolloongabba, Queensland 4102, Australia

Launceston General Hospital, Launceston, Tasmania 7250, Australia

Box Hill Hospital, Box Hill, Victoria, Australia

Andrew Love Cancer Care Centre, Geelong Hospital, Geelong, Victoria 3220, Australia

Austin Health, Melbourne, Victoria 3081, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria 8006, Australia

Alfred Hospital, Prahran, Victoria 3181, Australia

Sir Charles Gairdner Hospital, Perth, Western Australia 6009, Australia

Additional Information

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

Starting date: February 2003
Last updated: June 17, 2013

Page last updated: August 23, 2015

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