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Browsing by Subject "Phase 3 clinical trial"

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    • Article  

      Adjuvant Cytotoxic and Endocrine Therapy in Pre- and Postmenopausal Patients with Breast Cancer and One to Nine Infiltrated Nodes: Five-Year Results of the Hellenic Cooperative Oncology Group Randomized HE 10/92 Study 

      Fountzilas, George; Stathopoulos, G. P.; Kouvatseas, G.; Polychronis, A.; Klouvas, G. D.; Samantas, E.; Zamboglou, N.; Kyriakou, K.; Adamou, A.; Pectasides, Dimitrios; Economopoulos, T.; Kalofonos, H. P.; Bafaloukos, Dimitrios; Georgoulias, V.; Razi, E. D.; Koukouras, D.; Zombolas, V.; Kosmidis, Paraskevas A.; Skarlos, Dimosthenis V.; Pavlidis, Nicholas (2004)
      The present randomized phase III trial was designed to detect a 15% benefit in relapse-free survival (RFS) or overall survival (OS) from the incorporation of adjuvant tamoxifen to the combination of CNF [cyclophosphamide, ...

    • Article  

      CEOP-21 versus CEOP-14 chemotherapy with or without rituximab for the first-line treatment of patients with aggressive lymphomas: Results of the HE22A99 trial of the hellenic cooperative oncology group 

      Economopoulos, T.; Psyrri, A.; Dimopoulos, M. A.; Kalogera-Fountzila, Anna; Pavlidis, Nicholas; Tsatalas, C.; Nikolaides, C.; Mellou, S.; Xiros, N.; Fountzilas, George (2007)
      Background: In this study we investigated whether administering CEOP (cyclophosphamide, epirubicin, vincristine [Oncovin], and prednisone) every 2 weeks (CEOP-14) instead of every 3 weeks (the standard CEOP-21 regimen) ...

    • Article  

      Cisplatin/etoposide versus carboplatin/etoposide chemotherapy and irradiation in small cell lung cancer: A randomized phase III study 

      Kosmidis, Paraskevas A.; Samantas, E.; Fountzilas, George; Pavlidis, Nicholas; Apostolopoulou, F.; Skarlos, Dimosthenis V. (1994)
      The efficacy and toxicity of cisplatin/etoposide and carboplatin/etoposide combinations along with thoracic irradiation were prospectively assessed in patients with small cell lung cancer. Both combinations were equally ...

    • Article  

      Combination chemotherapy with paclitaxel plus carboplatin versus paclitaxel plus gemcitabine in inoperable non-small cell lung cancer: A phase III randomized study. Preliminary results 

      Kosmidis, Paraskevas A.; Mylonakis, N.; Dimopoulos, M. A.; Pavlidis, Nicholas; Fountzilas, George; Samantas, E.; Dimitriadis, K.; Kalofonos, H. P.; Tsavdaridis, D.; Skarlos, Dimosthenis V. (2000)
      Gemcitabine plus paclitaxel and paclitaxel plus carboplatin are active and well tolerated in patients with advanced non-small cell lung cancer, showing similar rates of response and survival. The Hellenic Cooperative ...

    • Article  

      Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: First report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial 

      Fountzilas, George; Dafni, U.; Papadimitriou, C.; Timotheadou, E.; Gogas, H.; Eleftheraki, A. G.; Xanthakis, I.; Christodoulou, C.; Koutras, A. K.; Papandreou, C. N.; Papakostas, P.; Miliaras, S.; Markopoulos, C.; Dimitrakakis, C.; Korantzopoulos, Panagiotis; Karanikiotis, C.; Bafaloukos, Dimitrios; Kosmidis, Paraskevas A.; Samantas, E.; Varthalitis, I.; Pavlidis, Nicholas; Pectasides, Dimitrios; Dimopoulos, M. A. (2014)
      Background: Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of ...

    • Article  

      Fluorouracil and leucovorin with or without interferon alfa-2a as adjuvant treatment, in patients with high-risk colon cancer. A randomized phase III study conducted by the Hellenic Cooperative Oncology Group 

      Fountzilas, George; Zisiadis, A.; Dafni, U.; Konstantaras, C.; Hatzitheoharis, G.; Papavramidis, S.; Bousoulegas, A.; Basdanis, G.; Giannoulis, E.; Dokmetzioglou, J.; Katsohis, C.; Nenopoulou, E.; Karvounis, N.; Briassoulis, E. Ch; Aravantinos, Gerasimos; Kosmidis, Paraskevas A.; Skarlos, Dimosthenis V.; Pavlidis, Nicholas (2000)
      Background: It has been shown in randomized studies that adjuvant treatment with the combination of fluorouracil (FU) and levamisole reduced the risk of recurrence and deaths of patients with stage III colon cancer. ...

    • Article  

      Fluorouracil and leucovorin with or without interferon alfa-2b in advanced colorectal cancer: Analysis of a prospective randomized phase III trial 

      Kosmidis, Paraskevas A.; Tsavaris, N.; Skarlos, Dimosthenis V.; Theocharis, D.; Samantas, E.; Pavlidis, Nicholas; Briassoulis, E. Ch; Fountzilas, George (1996)
      Purpose: To investigate if double modulation of fluorouracil (5-FU) with leucovorin (folinic acid [FA]) and interferon alfa-2b (IFN 2b) improves responses and survival in comparison to single modulation of 5-FU with FA. ...

    • Article  

      Paclitaxel (175 mg/m2) plus carboplatin versus paclitaxel (225 mg/m2) plus carboplatin in non-small cell lung cancer: A randomized study 

      Kosmidis, Paraskevas A.; Mylonakis, N.; Fountzilas, George; Samantas, E.; Athanasiades, A.; Pavlidis, Nicholas; Skarlos, Dimosthenis V. (1997)
      A recent phase II study by our group documented a response rate of 27% with the combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 175 mg/m2 plus carboplatin dosed to a target area under the ...

    • Article  

      Paclitaxel (175 mg/m2) plus carboplatin versus paclitaxel (225 mg/m2) plus carboplatin in non-small cell lung cancer: a randomized study. 

      Kosmidis, Paraskevas A.; Mylonakis, N.; Fountzilas, George; Samantas, E.; Athanasiades, A.; Pavlidis, Nicholas; Skarlos, Dimosthenis V. (1997)
      A recent phase II study by our group documented a response rate of 27% with the combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) 175 mg/m2 plus carboplatin dosed to a target area under the ...

    • Article  

      Paclitaxel and gemcitabine vs. paclitaxel and pegylated liposomal doxorubicin in advanced non-nasopharyngeal head and neck cancer. An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group 

      Fountzilas, George; Papakostas, P.; Dafni, U.; Makatsoris, T.; Karina, M.; Kalogera-Fountzila, Anna; Maniadakis, N.; Aravantinos, Gerasimos; Syrigos, K.; Bamias, A. T.; Christodoulou, C.; Economopoulos, T.; Kalofonos, H. P.; Nikolaou, A.; Angouridakis, N.; Stathopoulos, G. P.; Bafaloukos, Dimitrios; Pavlidis, Nicholas; Daniilidis, J. (2006)
      Background: The prognosis of patients with recurrent and/or metastatic head and neck cancer (HNC) is poor. Median survival of these patients following chemotherapy is in the range of 6 to 9 months. In the present randomized ...

    • Article  

      Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: Long-term efficacy results: A Hellenic Cooperative Oncology Group (HeCOG) study 

      Aravantinos, Gerasimos; Fountzilas, George; Kosmidis, Paraskevas A.; Dimopoulos, M. A.; Stathopoulos, G. P.; Pavlidis, Nicholas; Bafaloukos, Dimitrios; Papadimitriou, C.; Karpathios, S.; Georgoulias, V.; Papakostas, P.; Kalofonos, H. P.; Grimani, E.; Skarlos, Dimosthenis V. (2005)
      Background: We compared the combination plus Carboplatin plus paclitaxel, which is considered the treatment of choice for initial chemotherapy of advanced ovarian cancer (AOC) with a regimen combining alternating carboplatin ...

    • Article  

      A phase III study of 5-fluorouracil versus 5-fluorouracil plus interferon alpha 2b versus 5-fluorouracil plus leucovorin in patients with advanced colorectal cancer: A Hellenic Cooperative Oncology Group (HeCOG) study 

      Kalofonos, H. P.; Nikolaides, C.; Samantas, E.; Mylonakis, N.; Aravantinos, Gerasimos; Dimopoulos, M. A.; Gennatas, Constantinos; Kouvatseas, G.; Giannoulis, E.; Dervenis, C.; Basdanis, G.; Pavlidis, Nicholas; Androulakis, G.; Fountzilas, George (2002)
      We conducted a phase III study in patients with advanced colorectal carcinoma (ACC). The total number of patients randomized from October 1993 until July 1998 was 192, whereas therapy was started on 179 and 158 (82.3%) ...

    • Article  

      Postoperative radiation and concomitant bolus fluorouracil with or without additional chemotherapy with fluorouracil and high-dose leucovorin in patients with high-risk rectal cancer: A randomized phase III study conducted by the hellenic cooperative oncology group 

      Fountzilas, George; Zisiadis, A.; Dafni, U.; Konstantaras, C.; Hatzitheoharis, G.; Liaros, A.; Athanassiou, E.; Dombros, N.; Dervenis, C.; Basdanis, G.; Gamvros, O.; Souparis, A.; Briassoulis, E. Ch; Samantas, E.; Kappas, A. M.; Kosmidis, Paraskevas A.; Skarlos, Dimosthenis V.; Pavlidis, Nicholas (1999)
      Background: Randomized studies have shown that postoperative chemotherapy with or without radiation therapy (RT) improved local control and survival of patients with stages II or III rectal cancer. However, the optimal ...

    • Article  

      A prospective randomized phase III study in non-small-cell lung cancer comparing cisplatin, ifosfamide, vinblastine (VIP) versus cisplatin, ifosfamide and etoposide (VIP-16) 

      Kosmidis, Paraskevas A.; Mylonakis, N.; Fountzilas, George; Pavlidis, Nicholas; Samantas, E.; Karabelis, A.; Kattis, K.; Skarlos, Dimosthenis V. (1996)
      Background: It was recently reported that when ifosfamide was added to cisplatin and vinblastine the response rate was increased but not the survival in patients with non-small-cell lung cancer (NSCLC). The purpose of this ...

    • Article  

      Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: A randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG) 

      Skarlos, Dimosthenis V.; Samantas, E.; Briassoulis, E. Ch; Panoussaki, E.; Pavlidis, Nicholas; Kalofonos, H. P.; Kardamakis, D.; Tsiakopoulos, E.; Kosmidis, Paraskevas A.; Tsavdaridis, D.; Tzitzikas, J.; Tsekeris, P.; Kouvatseas, G.; Zamboglou, N.; Fountzilas, George (2001)
      Background: Concurrent platinum-etoposide chemotherapy given in combination with hyperfractionated thoracic radiation therapy (HTRT) in limited disease (LD) small cell lung cancer (SCLC) is associated with a high response ...

    • Article  

      Triple-negative phenotype is of adverse prognostic value in patients treated with dose-dense sequential adjuvant chemotherapy: A translational research analysis in the context of a Hellenic Cooperative Oncology Group (HeCOG) randomized phase III trial 

      Skarlos, P.; Christodoulou, C.; Kalogeras, K. T.; Eleftheraki, A. G.; Bobos, M.; Batistatou, Anna; Valavanis, C.; Tzaida, O.; Timotheadou, E.; Kronenwett, R.; Wirtz, R. M.; Kostopoulos, I.; Televantou, D.; Koutselini, E.; Papaspirou, I.; Papadimitriou, C.; Pectasides, Dimitrios; Gogas, H.; Aravantinos, Gerasimos; Pavlidis, Nicholas; Arapantoni, P.; Skarlos, Dimosthenis V.; Fountzilas, George (2012)
      Purpose: It is well recognized that breast cancer is a heterogeneous disease. The purpose of the current study was to classify patients according to the immunohistochemical phenotype of their tumors in an effort to evaluate ...

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