Clinical trial NCT00123318: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Official title: A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric cancer
Radiotherapy
Chemotherapy
Chemoradiation
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
Collaborators: name: The Royal Australian and New Zealand College of Radiologists
First posted: 2005-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
timeFrame: Final analysis will be at 3 years.
measure: The percentage of patients who complete the planned chemoradiation protocol
timeFrame: Final analysis will be at 3 years.
measure: The percentage of major radiotherapy protocol violations
timeFrame: Final analysis will be at 3 years.
Secondary outcomes:
measure: Median survival and overall survival at 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Penrith
country: Australia
facility: Nepean Cancer Care Centre
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater QRI
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Tugun
country: Australia
facility: East Coast Cancer Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Geelong
country: Australia
facility: Andrew Love Cancer Care Centre, Geelong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Prahran
country: Australia
facility: Alfred Hospital
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Trevor Leong
role: STUDY_CHAIR
References: