A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00123318
• Other study ID #: TROG 03.02
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2005
• Last updated: June 17, 2013
• Start date: February 2003
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• epirubicin
50mg/m2 IV day 1
• cisplatin
60mg/m2 IV day 1
• 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

Radiation:
• Radiotherapy
45Gy 25 Fractions, 5 days/week for 5 weeks

Locations

Country	Name	City	State
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Mater QRI	Brisbane	Queensland
Australia	Andrew Love Cancer Care Centre, Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Austin Health	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Nepean Cancer Care Centre	Penrith	New South Wales
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Alfred Hospital	Prahran	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales
Australia	East Coast Cancer Centre	Tugun	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Christchurch Hospital	Christchurch

Sponsors (2)

Lead Sponsor	Collaborator
Trans-Tasman Radiation Oncology Group (TROG)	The Royal Australian and New Zealand College of Radiologists

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity		Final analysis will be at 3 years.	Yes
Primary	The percentage of patients who complete the planned chemoradiation protocol		Final analysis will be at 3 years.	No
Primary	The percentage of major radiotherapy protocol violations		Final analysis will be at 3 years.	No
Secondary	Median survival and overall survival at 3 years		3 years	No

External Links

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