Breast Cancer
A phase II study evaluating the efficacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients after progression of chemotherapy or hormonal treatment in combination with lapatinib for metastatic disease.

Status: recruitment finalized
Disease indication: Breast Cancer
Protocol: CECOG/BC.1.2.001
Phase:
Number of participating countries: 4
Number of patients: 9
Number of sites: 7
A randomized phase III trial of Paclitaxel plus Bevacizumab versus Capecitabine plus Bevacizumab for the first line treatment of HER2-negative locally recurrent or metastatic breast cancer.

Status: recruitment closed
Disease indication: Breast recurrent or metastatic
Protocol: CECOG/BC1.3.005
Phase:
Number of participating countries: 12
Number of patients: 560
Number of sites: 55
A Randomized Phase II Study of Dose-Dense Fluorouracil plus Epirubicin75 plus Cyclophosphamide (FEC75) and Fluorouracil plus Epirubicin90 plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer

Status: successfully closed after recruitment
Disease indication: Breast, adjuvant
Protocol: CECOG/BREAST.2.2.005
Phase:
Number of participating countries: 4
Number of patients: 50
Number of sites: 3
A Randomized Phase III Study Comparing Concomitant Docetaxel plus Gemcitabine to Sequential Therapy of Docetaxel followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients.

Status: successfully closed after recruitment
Disease indication: Breast, metastatic
Protocol: CECOG/BC1.3.002
Phase:
Number of participating countries: 7
Number of patients: 100
Number of sites: 14
Eine multizentrische Studie der Phase III zum Vergleich von Capecitabin alleine oder in Kombination mit Trastuzumab bei Patientinnen mit HER2 positiver metastasierter Brustkrebserkrankung und Progression nach vorheriger Behandlung mit Trastuzumab (Behandlung nach Progression). A multicenter randomized phase III study to compare capecitabine alone versus capecitabine with trastuzumab in patients with HER2 positive metastatic breast cancer and progression after previous treatment with taxanes and trastuzumab (Treatment Beyond Progression, TBP).

Status: successfully closed after recruitment
Disease indication: Breast Cancer
Protocol: CECOG/GBG
Phase:
Number of participating countries: 1
Number of patients: 241
Number of sites: 16
Combination as First Line Chemotherapy in Metastatic Breast Cancer: GET versus FEC (CECOG-BM1) Published in: Proc. Am. Soc. Clin. Oncol. 25:26, 2003 and J. Clin. Oncol. 2005 Mar 1; 23(7):1401-8

Status: successfully closed after recruitment
Disease indication: Breast, metastatic
Protocol: CECOG-BM1
Phase:
Number of participating countries:
Number of patients: 259
Number of sites: 30
Phase III study of exemestane plus palbociclib (PD-0332991) versus chemotherapy in Hormonal Receptor (HR) positive/HER2 negative Metastatic Breast Cancer (MBC) with resistance to non-steroidal aromatase inhibitors. CECOG cooperates with the Spanish Breast Cancer Research Group (GEICAM) on this trial.

Status: recruiting
Disease indication: Breast Cancer
Protocol: CECOG/BC1.3.006-GEICAM/PEARL Trial
Phase:
Number of participating countries: 3
Number of patients: 149
Number of sites: 12
Colorectal Cancer
Phase III study of an optimized chomotherapy + Avastin ® Strategy + Tarceva ® in metastatic colorectal cancer. Optimox 3-Tarceva ® Study. C04-2.

Status: successfully closed after recruitment
Disease indication: Colorectal, metastatic
Protocol: DREAM-MO18420
Phase:
Number of participating countries: 1
Number of patients: 50
Number of sites: 5
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX 6 + Cetuximab versus FOLFIRI + Cetuximab as first-line therapy in patients with metastatic colorectal cancer.

Status: successfully closed after recruitment
Disease indication: Colorectal
Protocol: CECOG/CORE.1.2.001
Phase:
Number of participating countries: 12
Number of patients: 150
Number of sites: 25
A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with metastatic colorectal cancer.

Status: recruitment finalized
Disease indication: Colorectal
Protocol: CECOG/CORE.1.2.002
Phase:
Number of participating countries: 12
Number of patients: 150
Number of sites: 22
Esophago-Gastric Cancer
Phase II study of docetaxel in combination with oxaliplatin in patients with metastatic or locally recurrent esophagogastric cancer previously untreated with chemotherapy for advanced disease

Status: successfully closed after recruitment
Disease indication: Esophago-Gastric Cancer
Protocol: CECOG/ESGAS 1.2.001
Phase:
Number of participating countries:
Number of patients:
Number of sites:
A Phase II Study of Irinotecan, mitomycin C and capecitabine as second line chemotherapy for patients with metastatic or locally recurrent esophago-gastric cancer previously treated with chemotherapy for advanced disease.

Status: successfully closed after recruitment
Disease indication: Esophago-Gastric Cancer
Protocol: CECOG/ESGAS 1.2.002
Phase:
Number of participating countries:
Number of patients:
Number of sites:
Gastrointestinal Stromal Tumours
Open-label Trial of Glivec in Patients with Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumors Expressing c-kit

Status: successfully closed after recruitment
Disease indication: GIST
Protocol: CECOG/GIST 1.2.001
Phase:
Number of participating countries: 10
Number of patients: 125
Number of sites: 18
Molecular mechanisms associated with response/resistance to Glivec in patients with unresectable or metastatic malignant gastrointestinal stromal tumur expressing c-kit.

Status: successfully closed after recruitment
Disease indication: Gastrointestinal Stromal Tumours
Protocol: GIST 1.2.002 Molecular Substudy
Phase:
Number of participating countries: 12
Number of patients: 150
Number of sites: 25
Non Small Cell Lung Cancer
Dacomitinib (PF-00299804) in combination with pemetrexed for patients with advanced non squamous non-small cell lung cancer (NSCLC): a phase I trial evaluating the MTD and safety of pemetrexed + dacomitinib treatment in patients with stage IV NSCLC.

Status: recruitment ongoing
Disease indication: Lung, NSCLC
Protocol: CECOG/NSCLC.1.1.001
Phase:
Number of participating countries: 1
Number of patients: 352
Number of sites: 24
A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrag Good vs VeriStrat Poor” – EMPHASIS-lung ETOP 3-12 with 4 sites in Israel and 2 sites in Austria.

Status: closed
Disease indication: Lung, NSCLC
Protocol: CECOG collaborates in the EMPHASIS-lung ETOP 3-12 Trial
Phase:
Number of participating countries: 2
Number of patients:
Number of sites: 6
A phase III, double-blinded, placebo-controlled study of Pemetrexed plus best supportive care vs. best supportive care as maintenance therapy immediately following induction treatment for advanced Non-Small Cell Lung Cancer.

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: H3E-MC-JMEN
Phase:
Number of participating countries: 7
Number of patients: 168
Number of sites: 21
A Phase II Trial of Dose-Dense Paclitaxel and Cisplatin as Neo- Adjuvant Chemotherapy for Operable Stage II and IIIA Non-Small Cell Lung Cancer

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: CECOG/NSCLC.3.2.002
Phase:
Number of participating countries: 3
Number of patients:
Number of sites: 5
Phase III comparing first line combination therapy versus sequential chemotherapy with Docetaxel and Gemcitabine in advanced Non Small Cell Lung Cancer (NSCLC) A cooperation with the Thoraxklinik Heidelberg, Germany.

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: Gemtax III
Phase:
Number of participating countries: 4
Number of patients: 4
Number of sites: 1
An open, randomized, multicentre, Phase II Pilot Study of Docetaxel and Cisplatin in the adjuvant treatment of Non-Small Cell Lung Cancer (NSCLC) Stage I-II

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: CECOG/NSCLC2.2.001
Phase:
Number of participating countries: 2
Number of patients: 80
Number of sites: 6
Gemcitabine and Cisplatin With and Without Subsequent Maintenance Therapy with Single Agent Gemcitabine in Stage IV Non-small Cell Lung Cancer. A Randomized, Multicentric Study
Published in : Lung Cancer 41, Suppl. 2:O-88, 203 and Lung Cancer 2006 May; 52(2):155-63

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: CECOG-NSCLC1
Phase:
Number of participating countries:
Number of patients:
Number of sites:
CECOG is proud to cooperate with the European Thoracic Oncology Platform (ETOP) on the trial “A randomized, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC”.
Trial News: The SPLENDOUR trial included the first patient

Status: successfully closed after recruitment
Disease indication: Lung, NSCLC
Protocol: CECOG/Splendour Trial
Phase:
Number of participating countries: 5
Number of patients: 348
Number of sites: 13
Pancreatic Cancer
Gemcitabine plus Capecitabine versus Gemcitabine alone in advanced pancreatic cancer. A randomized phase III trial. SAKK 44/00

Status: successfully closed after recruitment
Disease indication: Pancreas
Protocol: CECOG/PAN 1.3.001, SAKK 44/00
Phase:
Number of participating countries:
Number of patients: 57
Number of sites: 3
Prostate Cancer
A randomised open-label (ZOMETA® + hormonal ablation vs. hormonal ablation alone) multicenter prospective clinical study to show the efficacy of intravenous ZOMETA® (zoledronic acid) 4 mg for prevention of bone metastases in hormone-naïve high risk patients with locally advanced prostate cancer.

Status: successfully closed after recruitment
Disease indication: Prostate
Protocol: CECOG/PROSTATE 1.2.001
Phase:
Number of participating countries: 17
Number of patients: 376
Number of sites: 51

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