Recent Achievements
1. Colorectal cancer
Trials closed to accrual
The EORTC 40052 trial is an intergroup collaboration within the PETACC framework, PETACC-8, coordinated by the Fédération Francophone de la Cancérologie Digestive (FFCD). This study compares adjuvant treatment of completely resected colon cancer with FOLFOX4 versus FOLFOX4 plus cetuximab. The trial was closed to accrual in November 2009 with 2565 patients randomized.
Trials open to accrual
The ongoing study of perioperative chemoradiotherapy in locally advanced rectal cancer, the EORTC 40054-22026 PETACC-6 trial, opened in 2008. In this trial, 1090 eligible patients will be randomized between capecitabine with radiotherapy (RT) before surgery, followed by capecitabine after surgery and capecitabine with oxaliplatin and RT before surgery, followed by capecitabine and oxaliplatin after surgery. The primary endpoint is disease free survival. As of November 2010, 545 patients have been enrolled. The trial has been activated in Germany, Belgium, Israel, France and Australia. Activation of remaining centers is ongoing. Accrual is expected to be completed by December 2011. This is the first GI Group study to use the remote data capture system (RDC) which should make it easier to enter patient data, decrease errors, and facilitate follow-up queries.
Trials in activation process
Following the EORTC 40983 EPOC (European Peri-Operative Colon) trial which arrived at the practice altering conclusion that perioperative FOLFOX4 chemotherapy is safe and reduces the risk of progression free survival (PFS) events by approximately 25% over surgery alone in patients with initially resectable liver-only metastases from CRC, the GI Group is launching the EORTC 40091 BOS2 trial, a randomized phase II trial evaluating the efficacy of FOLFOX alone, FOLFOX plus bevacizumab, and FOLFOX plus panitumumab as perioperative treatment in patients with resectable liver metastases from wild type KRAS CRC. The trial will enroll 360 patients with metachronous or synchronous liver metastases (up to eight) from CRC considered to be completely resectable. The primary endpoint is PFS rate at one year.
2. Gastric cancer
Trials in activation process
The GI Group Gastric Cancer Task Force has established a new trial, the EORTC 40071 trial: Effectiveness of first line treatment with lapatinib and ECF/X in metastatic gastric cancer according to HER2 and EGFR status: a randomized phase II trial. We will investigate if the addition of lapatinib to chemotherapy is susceptible to increase median PFS for patients whose tumors are HER2 positive by FISH and IHC. We will also explore the effect of adding lapatinib to chemotherapy in two additional populations: 1) patients that are HER2 negative by FISH, but HER2 positive by IHC, and 2) patients that are HER2 negative by IHC, but who are EGFR positive by FISH or IHC. Additionally, the study will assess the concordance of FISH and IHC determinations of HER2. It is planned to screen a total of 350 patients for their marker status.
Initiation packages were sent to the sites in July 2010, and activation of an initial six sites is planned during the start-up phase (Jules Bordet, Mainz, Leuven, Budapest, Lisbon, Gustave Roussy). This trial was presented at the ASCO 2010 Annual Meeting.
3. Pancreatic cancer
Trials in activation process
Following the randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study results (poster at ASCO 2010 and published in JCO 28(29), 2010) which concluded that adjuvant gemcitabine based CRT after R0 resection of pancreatic head cancer is feasible, well-tolerated, and not deleterious, the GI Group will participate to the joint RTOG 0848/EORTC 40084/22084 phase III study. This ongoing study is planned to open in Europe in Q1 of 2011 and will address two important questions: a) the impact of adding erlotinib and the underlying identification of its predictive biomarkers, and b) the impact of radiation therapy added to a full adjuvant gemcitabine course. OS is the primary endpoint.
The protocol is open in 80 sites in the United States. 300 patients out of the projected 950 in the study will be accrued through the EORTC network.