Gastric CancerPhase 2/3TOPGEARNCT01924819
Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma
A Phase 2/3 study testing Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Preoperative chemoradiotherapy and Gastric resection in people with Gastric Cancer, run by Australasian Gastro-Intestinal Trials Group at 59 sites in 10 countries.
Trial summary
Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Preoperative chemoradiotherapy and Gastric resection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 59 sitesin 10 countries
- Study dates
- Sep 2009to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (GEJ) that is:
- Stage IB (T1N1 only, T2N0 not eligible) - IIIC, i.e. T3 - T4 and/or node positive, according to American Joint Committee on Cancer (AJCC) 7th edition.
- Considered operable following initial staging investigations (surgeon believes that an R0 resection can be achieved) (GEJ tumours are defined as tumours that arise in the cardia or at the GEJ that do not involve more than 2cm of the lower esophagus, i.e. Siewert Type II and Siewert Type III)
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function defined as follows:
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- Bone marrow: Haemoglobin >=90 g/L, Absolute neutrophil count (ANC) >=1.5 x 10⁹ /L, White blood cell count >=3 x 10⁹ /L, Platelet count >=100 x 10⁹ /L
- Hepatic: Serum bilirubin <=1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and/or alanine transaminase (ALT) <=3.0 x ULN
- Renal: Serum creatinine <=0.150 mmol/L, Calculated creatinine clearance >=50 mL/min
- Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation
- Any patient with a history of ischaemic heart disease and abnormal ECG, or who is over 60 years of age should have a pre-treatment evaluation of cardiac function with a multigated acquisition (MUGA) scan or echocardiogram. Patients will only be included if the left ventricular ejection fraction is >=50%.
- Written informed consent obtained before randomization
- Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice adequate contraceptive measures.
Who cannot join
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer in the 5 years before randomization except for the following. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, and patients with carcinoma in situ of the cervix that has been treated by operation only are eligible, even if they were diagnosed and treated within the 5 years before randomization.
- 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 and other contraindications to epirubicin
Show all 14Show fewer
- Patients with impaired gastrointestinal absorption for whatever reason
- Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
- Clinically significant sensorineural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
- Severe tinnitus
- Renal impairment (GFR <=50ml/min)
- Peripheral neuropathy >=grade 2
- Inability to tolerate intravenous hydration e.g due to cardiac disease
- Co-morbidities (based on clinical judgement by the investigator) that in the view of the investigator would preclude the safe administration of cisplatin.
Trial locations and contacts
59 sites in 10 countries.
59 sites in 10 countries
Australia21 sites
Flinders Medical Centre
Adelaide, South Australia
Princess Alexandra Hospital
Brisbane, Queensland
Geelong Hospital
Geelong, Victoria
Royal Hobart Hospital
Hobart, Tasmania
Launceston General Hospital
Launceston, Tasmania
Austin Hospital
Melbourne, Victoria
Monash Medical Centre
Melbourne, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria
St Vincent's Hospital
Melbourne, Victoria
Sunshine Hospital (Western Health)
Melbourne, Victoria
Sir Charles Gairdner Hospital
Nedlands, Western Australia
Calvary Mater Newcastle
Newcastle, New South Wales
Chris O Brien Lifehouse
Sydney, New South Wales
Liverpool Hospital
Sydney, New South Wales
Nepean Hospital
Sydney, New South Wales
Prince of Wales Hospital
Sydney, New South Wales
Royal North Shore Hospital
Sydney, New South Wales
St George Hospital
Sydney, New South Wales
Westmead Hospital
Sydney, New South Wales
The Tweed Hospital
Tweed Heads, New South Wales
Wollongong Hospital
Wollongong, New South Wales
Canada15 sites
Royal Victoria Regional Health Centre
Barrie, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario
Grand River Regional Cancer Center, Kitchener
Kitchener, Ontario
London Regional Cancer Program
London, Ontario
Hopital Maisonneuve-Rosemont
Montreal, Quebec
Hospital Notre-Dame
Montreal, Quebec
Jewish General Hospital
Montreal, Quebec
Ottawa Health Research Institute
Ottawa, Ontario
Allan Blair Cancer Centre
Regina, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
Odette Cancer Centre, Sunnybrook Hospital
Toronto, Ontario
UHN - Princess Margaret Hospital
Toronto, Ontario
BCCA - Vancouver Centre
Vancouver, British Columbia
Cancer Care Manitoba
Winnipeg, Manitoba
Belgium7 sites
AZ Klina
Brasschaat, 2930
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Hospital De Jolimont
La Louvière, 7100
U.Z Leuven Campus Gasthuisberg
Leuven, 3000
AZ Damiaan
Ostend, 8400
AZ Turnhout- Campus Sint Elisabeth
Turnhout, 2300
Centre Hospitalier Peltzer- La Tourelle
Verviers, 4800
France4 sites
Institut Sainte Catherine
Avignon, 84918
CHRU de Besancon Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier de Belfort Montbeliard site du Mittan
Montbéliard, 24 200
Centre Paul Strauss
Strasbourg, 67085
Spain4 sites
Institut Catala d Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Badalona
Vall D Hebron University Hospital
Barcelona, 08035
ICO L Hospitalet Hospital Duran i Reynals (Institut Catala D Oncologia)
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clinico Universitario De Valencia
Valencia, 46010
New Zealand3 sites
Auckland Hospital
Auckland
Dunedin Hospital
Dunedin
Waikato Hospital
Hamilton
Israel2 sites
Rambam Medical Center
Haifa, 31096
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Germany1 site
Klinikum der Universitaet Muenchen - Campus Grosshadern
München, Bavaria, 81377
About this study
Official title: A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer
Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.
Read the detailed description
Purpose:
The purpose of this phase II/III clinical trial is to determine if pre-operative chemoradiotherapy improves overall survival in participants with resectable gastric cancer.
Trial details:
Participants will be randomised to receive either pre-operative chemotherapy or pre-operative chemoradiotherapy. The will undergo surgery and then receive further post-operative chemotherapy. Participants will be followed up for 5 years after treatment.
- Conditions
- Gastric Cancer
- Being tested
- Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Preoperative chemoradiotherapy, Gastric resection
- Keywords
- Gastric cancer, Stomach cancer, Chemoradiotherapy, Surgery, Chemotherapy, Neoadjuvant
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxelDrug
Also called Epirubicin hydrochloride, Pharmorubicin, Ellence, Platinol, 5-FU, Adrucil, Carac, Efudex. Efudix, Xeloda
Epirubicin 50 mg/m2 IV day 1, cisplatin 60 mg/m2 IV day 1, 5-fluorouracil 200 mg/m2/d IV 21 day continuous infusion (ECF chemotherapy).
Epirubicin 50 mg/m2 IV day 1, Cisplatin 60 mg/m2 IV day 1, Capecitabine (X = Xeloda) 625mg/m2, bid days 1-21 (ECX chemotherapy)
Epirubicin 50mg/m2 IV day 1, Oxaliplatin (O) 130mg/m2 IV day 1, Capecitabine 625mg/m2, bid days 1-21 (EOX chemotherapy)
5-Fluorouracil 2600 mg/m² IV 24 h infusion day 1, Leucovorin (L) 200 mg/m² IV day 1, Oxaliplatin 85 mg/m² IV day 1, Docetaxel (T) 50 mg/m² IV day 1 (FLOT chemotherapy)
Preoperative chemoradiotherapyRadiation
Chemotherapy: Continuous infusional 5-fluorouracil 200mg/m2/day, 7 days per week, throughout the entire period of radiotherapy or capecitabine 825 mg/m2, oral tablet twice daily, days 1-5 of each week of radiotherapy (without weekends).
Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks.
Gastric resectionProcedure or surgery
The acceptable resections are a total gastrectomy, a subtotal gastrectomy, and an esophagogastrectomy (Ivor-Lewis esophagogastrectomy for gastroesophageal junction cancers [Siewert Type II and Siewert Type III] invading up to but no more than 2cm of the lower esophagus). The minimum extent of the operation should be a D1+ lymph node dissection but it is recommended that a D2 dissection be performed or a D1+ for gastroesophageal junction cancers requiring an esophagogastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative chemoradiotherapy | Experimental | 2 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine).
OR epirubicin + oxaliplatin + capecitabine OR 3 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel
5 weeks preoperative chemoradiotherapy.
Gastric resection.
3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine).
OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel Receives: Drug: Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel; Radiation: Preoperative chemoradiotherapy; Procedure: Gastric resection |
| Preoperative chemotherapy | Active comparator | 3 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine).
OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel
Gastric resection.
3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine) OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel Receives: Drug: Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel; Procedure: Gastric resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The interval from the date of randomisation to the date of death from any cause, or the date last known alive.
Measured: Up to 5 years
Secondary outcomes (4)
Disease free survival
The time from the date of randomisation to the first observation of disease progression or death due to any cause.
Measured: Up to 5 years
Pathological response rate
The extent of reduction in tumour size following pre-operative treatment, as determined by macroscopic and microscopic assessment of the tumour.
Measured: At time of surgery
Proportion of participants with given grades of toxicities
The proportion of participants starting at least one cycle of treatment and the grades of the toxicities reported.
Measured: Up to 5 years
Surgical complete resection rate (R0)
The complete macroscopic resection of gross tumour with negative surgical margins.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startSep 2009
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Collaborators
- National Health and Medical Research Council, Australia, Trans Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Trevor Leong, MBBS, MD, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924819
- Sponsor's protocol ID
- AG0407GR
- Other IDs
- ACTRN12609000035224, U1111-1146-0762, TROG 08.08, 22114-40111, GA.1
- Acronym
- TOPGEAR
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2013
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leong T, Smithers BM, Michael M, Haustermans K, Wong R, Gebski V, O'Connell RL, Zalcberg J, Boussioutas A, Findlay M, Willis D, Moore A, Murray WK, Lordick F, O'Callaghan C, Swallow C, Darling G, Miller D, Strickland A, Liberman M, Mineur L, Simes J; Australasian Gastro-Intestinal Trials Group, National Health and Medical Research Council Clinical Trials Centre, Trans-Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer, and Canadian Cancer Trials Group. Preoperative Chemoradiotherapy for Resectable Gastric Cancer. N Engl J Med. 2024 Nov 14;391(19):1810-1821. doi: 10.1056/NEJMoa2405195. Epub 2024 Sep 14.
PubMed 39282905
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT01924819
- Acronym / sponsor ID
- TOPGEAR / AG0407GR
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Stomach cancer, Chemoradiotherapy, Surgery, Chemotherapy, Neoadjuvant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Australasian Gastro-Intestinal Trials GroupResearch network
- Collaborators
- National Health and Medical Research Council, Australia, Trans Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group
- Study start
- Sep 2009
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.
Detailed description
Purpose:
The purpose of this phase II/III clinical trial is to determine if pre-operative chemoradiotherapy improves overall survival in participants with resectable gastric cancer.
Trial details:
Participants will be randomised to receive either pre-operative chemotherapy or pre-operative chemoradiotherapy. The will undergo surgery and then receive further post-operative chemotherapy. Participants will be followed up for 5 years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative chemoradiotherapy | Experimental | Drug: Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Radiation: Preoperative chemoradiotherapy, Procedure: Gastric resection2 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 3 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel 5 weeks preoperative chemoradiotherapy. Gastric resection. 3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel |
| Preoperative chemotherapy | Active comparator | Drug: Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Procedure: Gastric resection3 cycles preoperative chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine). OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel Gastric resection. 3 cycles adjuvant chemotherapy with: epirubicin + cisplatin + 5-fluorouracil. (5-fluorouracil may be replaced with capecitabine) OR epirubicin + oxaliplatin + capecitabine OR 4 cycles of 5-fluorouracil +Leucovorin + oxaliplatin + docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (GEJ) that is:
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function defined as follows:
- Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation
Key exclusion criteria (14 listed)
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer in the 5 years before randomization except for the following. Patients with squamous or basal cell carcinoma of the skin that has been effectively treated, and patients with carcinoma in situ of the cervix that has been treated by operation only are eligible, even if they were diagnosed and treated within the 5 years before randomization.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxelAlso: Epirubicin hydrochloride, Pharmorubicin, Ellence, Platinol, 5-FU, Adrucil, Carac, Efudex. Efudix, XelodaEpirubicin 50 mg/m2 IV day 1, cisplatin 60 mg/m2 IV day 1, 5-fluorouracil 200 mg/m2/d IV 21 day continuous infusion (ECF chemotherapy). Epirubicin 50 mg/m2 IV day 1, Cisplatin 60 mg/m2 IV day 1, Capecitabine (X = Xeloda) 625mg/m2, bid days 1-21 (ECX chemotherapy) Epirubicin 50mg/m2 IV day 1, Oxaliplatin (O) 130mg/m2 IV day 1, Capecitabine 625mg/m2, bid days 1-21 (EOX chemotherapy) 5-Fluorouracil 2600 mg/m² IV 24 h infusion day 1, Leucovorin (L) 200 mg/m² IV day 1, Oxaliplatin 85 mg/m² IV day 1, Docetaxel (T) 50 mg/m² IV day 1 (FLOT chemotherapy) | Drug | Preoperative chemoradiotherapy, Preoperative chemotherapy |
| Preoperative chemoradiotherapyChemotherapy: Continuous infusional 5-fluorouracil 200mg/m2/day, 7 days per week, throughout the entire period of radiotherapy or capecitabine 825 mg/m2, oral tablet twice daily, days 1-5 of each week of radiotherapy (without weekends). Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks. | Radiation | Preoperative chemoradiotherapy |
| Gastric resectionThe acceptable resections are a total gastrectomy, a subtotal gastrectomy, and an esophagogastrectomy (Ivor-Lewis esophagogastrectomy for gastroesophageal junction cancers [Siewert Type II and Siewert Type III] invading up to but no more than 2cm of the lower esophagus). The minimum extent of the operation should be a D1+ lymph node dissection but it is recommended that a D2 dissection be performed or a D1+ for gastroesophageal junction cancers requiring an esophagogastrectomy. | Procedure or surgery | Preoperative chemoradiotherapy, Preoperative chemotherapy |
Primary outcome
Overall survival
Time frame: Up to 5 years
The interval from the date of randomisation to the date of death from any cause, or the date last known alive.
4 secondary outcomes
Disease free survival
Time frame: Up to 5 years
Pathological response rate
Time frame: At time of surgery
Proportion of participants with given grades of toxicities
Time frame: Up to 5 years
Surgical complete resection rate (R0)
Time frame: At the time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 39282905Leong T, Smithers BM, Michael M, Haustermans K, Wong R, Gebski V, O'Connell RL, Zalcberg J, Boussioutas A, Findlay M, Willis D, Moore A, Murray WK, Lordick F, O'Callaghan C, Swallow C, Darling G, Miller D, Strickland A, Liberman M, Mineur L, Simes J; Australasian Gastro-Intestinal Trials Group, National Health and Medical Research Council Clinical Trials Centre, Trans-Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer, and Canadian Cancer Trials Group. Preoperative Chemoradiotherapy for Resectable Gastric Cancer. N Engl J Med. 2024 Nov 14;391(19):1810-1821. doi: 10.1056/NEJMoa2405195. Epub 2024 Sep 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trevor Leong, MBBS, MD study chair
Peter MacCallum Cancer Centre, Australia
59 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel, Preoperative chemoradiotherapy and Gastric resection in people with Gastric Cancer, run by Australasian Gastro-Intestinal Trials Group at 59 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Australia, Canada, Belgium, France, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.