Da Vinci: Phase II-III trial of irinotecan versus irinotecan + De Gramont schedule 5-fluorouracil and folinic acid in patients with previously treated metastatic colorectal cancer (AG103CR)
Quasar 2: Phase III study of capecitabine and bevacizumab as adjuvant treatment of colorectal cancer
AGITG study
Participants Patients with treated metastatic colorectal cancer
Phase III adjuvant trial in pancreatic cancer comparing: 5-fluorouracil + D-L folinic acid with gemcitabine or no adjuvant treatment (ESPAC-3)
Gastrointestinal stromal tumors (GIST) expressing KIT receptor: adjuvant imatinib mesylate (Glivec) versus no further therapy after surgery (EORTC 62024)
European Study Group for Pancreatic Cancer (ESPAC)–AGITG study
Participants
Patients who undergo surgery for pancreatic cancer
Treatment
5-fluorouracil + D-L folinic acid + surgery
gemcitabine
surgery
Outcome measures
disease-free survival
survival
quality of life
Recruitment target: 990 (150 from Australia and New Zealand)
Funding: National Health and Medical Research Council (NHMRC)
Status: open to recruitment
Recruitment target: 150
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants
Patients with operated gastrointestinal stromal tumour
Phase III study of BMS-582664 with cetuximab versus placebo with cetuximab in patients previously treated with combination chemotherapy for metastatic colorectal carcinoma (CO.20)
ATTAX 3: Randomised phase II study evaluating triplet chemotherapy regimens incorporating cisplatin, fluoropyrimidine and either weekly docetaxel or epirubicin plus or minus panitumumab in advanced oesophagogastric cancer
National Cancer Institute of Canada (NCIC)-AGITG study
Participants
Patients with advanced colorectal cancer
Treatment • cetuximab and BMS-582664 • cetuximab and placebo
Outcome measures • survival • progression-free survival • tumour response • toxicity • quality of life
Recruitment target: 370
Funding: Bristol-Myers Squibb and NCIC
Status Open to recruitment in 2008
AGITG study
Participants Patients with advanced oesophagogastric cancer
Treatment • cisplatin, fluoropyrimidine and weekly docetaxel or epirubicin
• cisplatin, fluoropyrimidine and weekly docetaxel or epirubicin plus panitumumab
Outcome measures
• tumour response
• survival
• progression-free survival
• toxicity
• quality of life
• tissue biomarkers
Recruitment target: 100
Status Open to recruitment in 2008
DECO: Randomised phase II trial of weekly docetaxel (Taxotere) chemoradiotherapy with or without cetuximab (Erbitux) in the treatment of localised resectable cancer of the oesophagus
Resectable gastric study: Randomised phase III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for gastric cancer
AGITG study
Participants
Patients with resectable oesophageal cancer
Register: Phase II study in adults with newly diagnosed gastrointestinal stromal tumour (GIST) incorporating risk-stratification and sequential dose-escalation of imatinib in patients with tumours containing an exon 9 mutation and subsequent addition of nilotinib in poor responders
PETACC 6: Phase III randomised study of preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs capecitabine alone in rectal cancer
AGITG study
Participants Adult patients with a new diagnosis of advanced GIST
Treatment • imatinib
• nilotinib
Outcome measures
• progression-free survival
• toxicity
• pharmacodynamic markers
• efficacy of early nilotinib
• survival
Recruitment target: 100
Status Open to recruitment in 2008
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants Patients with locally advanced rectal cancer
MAX: a randomised phase II-III study to evaluate the role of Mitomycin C [mitomycin], Avastin [bevacizumab] and Xeloda [capecitabine] in patients with untreated metastatic colorectal cancer (AG0501CR)
EORTC
40983: Pre- and postoperative chemotherapy with oxaliplatin, 5-fluorouracil
and leucovorin compared with surgery alone for resectable liver metastases
of colorectal origin
Investigator-initiated intergroup trial: AGITG
Participants
Patients with previously untreated metastatic colorectal cancer for whom the investigator considers capecitabine monotherapy appropriate
Outcome measures
. treatment toxicity
. response rate
. progression-free survival
. overall survival
. quality of life
. cost-effectiveness
Recruitment: 471
Funding: Roche
Status: In follow-up
Investigator-initiated
intergroup trial: AGITG and EORTC
Status: Open to recruitment
Participants
Patients with potentially resectable liver metastases from colorectal
origin. Patients will not have received prior therapy for advanced
disease.
CO.17: Phase III study of cetuximab and best supportive care versus best supportive care in patients with pretreated metastatic epidermal-growth-factor-receptor (EGFR-positive colorectal carcinoma)
ATTAX 2: Phase II study of cetuximab plus docetaxel in docetaxel-refractory patients with EGFR-positive cancer (AG0603G)
National Cancer Institute of Canada (NCIC)-AGITG study
Participants
Patients with inoperable biliary carcinomas advanced oesophageal of gastric cancer
Treatment cetuximab + supportive care
supportive care
Outcome measures
• survival
• time to progression
• tumour response
• quality of life
Recruitment: 252
Funding: Bristol-Myers Squibb and NCIC
Status: In follow-up
AGITG study
Participants
Patients with inoperable biliary carcinomas advanced oesophageal of gastric cancer
Oral
uracil/ftorfur plus leucovorin compared with 5-fluorouracil plus leucovorin
in the treatment of patients with stages II and III carcinoma of the
colon (C-06)
5-fluorouracil
plus leucovorin and oxaliplatin compared with 5-fluorouracil plus
leucovorin for the treatment of patients with stages II and III carcinoma
of the colon (C-07)
Investigator-initiated
intergroup trial: AGITG and NSABP
Status: closed to recruitment
Participants
Patients with stage II and stage III adenocarcinoma of the colon,
no metastatic disease and a life expectancy of at least 10 years (excluding
the diagnosis of cancer)
Outcome measures
disease-free survival
survival
quality of life
prognostic significance of genetic and biologic markers and
their relationships with tumour characteristics
Recruitment: 11
Funding: NSABP and NCI
Completely
resected colorectal cancer
5-fluorouracil
+ leucovorin
uracil
and ftorfur
+ leucovorin
SURVIVAL,
QUALITY OF LIFE AND BIOMARKERS
Investigator-initiated
intergroup trial: AGITG and NSABP
Status: closed to recruitment
Participants
Patients with stage II and III adenocarcinoma of the colon, no metastatic
disease and a life expectancy of at least 10 years (excluding the
diagnosis of cancer)
Phase III randomised, intergroup, international trial assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing the KIT receptor tyrosine kinase (CD117) (EORTC 62005)
Gofurtgo: Phase II study of fixed-dose rate gemcitabine–oxaliplatin integrated with concomitant 5-fluorouracil and radiotherapy to treat localised pancreatic cancer (AG0503P)
European Organisation for Research and Treatment of Cancer (EORTC)–AGITG study
Participants
Patients with histologically documented diagnosis of unresectable and/or metastatic GIST, which is incurable with any conventional multimodality approach. Patients will have immunohistochemical documentation of c-kit (CD117) expression by tumour documented by DAKO antibody staining.