Endometrial Committee

Click here to load reader

  • date post

    14-Jan-2016
  • Category

    Documents

  • view

    31
  • download

    0

Embed Size (px)

description

Endometrial Committee. David Scott Miller, M.D., F.A.C.O.G., F.A.C.S. Director and Dallas Foundation Chair in Gynecologic Oncology Professor of Obstetrics & Gynecology University of Texas Southwestern Medical Center Dallas, Texas, U.S.A. Resected Endometrial. - PowerPoint PPT Presentation

Transcript of Endometrial Committee

  • Endometrial CommitteeDavid Scott Miller, M.D., F.A.C.O.G., F.A.C.S.Director and Dallas Foundation Chair in Gynecologic OncologyProfessor of Obstetrics & GynecologyUniversity of Texas Southwestern Medical CenterDallas, Texas, U.S.A.

  • Resected Endometrial GOG0249: A Phase III Trial of Pelvic Radiation Therapy versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Cancer (23 Mar 2009)RTOG

  • Resected Endometrial PORTEC 3: Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial CarcinomaMaNGO, ANZGOG, NRCI, NCIC-CTG, NSGO

  • Resected Endometrial GOG258 (UC0704): A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Cancer (29 Jun 2009)RTOG

  • Study proposalProposed new study exploring if the combination of RT and CT is superior to CT:After 4 - A Phase III intergroup trial on adjuvant therapy in radically operated endometrial cancer patients (FIGO stage IC-IIIC) with high risk for micrometastatic diseaseNSGOPooled survival dataThe combination of RT + CT is better than RTResults of previous studies:Thomas Hogberg, Lund Univ Hosp Oct 2009

  • PORTEC-3 Unless there is something fundamentally wrong with NSGO-9501/EORTC-55991 PORTEC-3 will most probably show that CMT is better than RT

    When PORTEC-3 is published CMT will probably become standard treatment

    The question about the contribution of RT will remain unanswered

    We have a time-frame in which we can resolve the question of the value of addition of radiotherapy to chemotherapy

  • Radical surgeryTAH+BSOLACTx4Primary endpointOverall survival (OS)CTx2RTRandomizationMain inclusion criteriaa. Endometrioid carcinomab. Stage 1C grade 3 c. Stage IIA grade 3 and MI50%, IIB d. Stage IIIA-CRadical surgery, LA recommended but optionalMain exclusion criteriaSerous or clear cell carcinomaIIIA with only pos fluid cytologyCT :Paclitaxel 175 mg/m2, carboplatin AUC 5-6 (calculated) q 3 weeksN=1000Proposed studyThomas Hogberg, Lund Univ Hosp Oct 2009

  • Pelvic RecurrenceGOG0238: A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-only Recurrence of Carcinoma of the Uterine CorpusRTOG, NCRI, SWOG

  • Advanced/RecurrentNCIC: EN 8: Randomized Phase III Study of progestational hormone therapy versus deforolimus in women with recurrent or metastatic endometrial cancerACRIN, AGO-AUST, AGO-OVAR, ANZOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOG

  • EN.8 - A PHASE III STUDY OF STANDARD THERAPY VERSUS RIDAFOROLIMUS IN WOMEN WITH RECURRENT OR METASTATIC ENDOMETRIAL CANCER WHO HAVE PREVIOUS HAD CHEMOTHERAPYInterested Groups: ACRIN, AGO-AUST, AGO-OVAR, ANZGOG?, DUTCH GOG, EORTC, GEICO, GINECO, JGOG, MANGO, MITO, NCRI, NSGO, SWOG

  • Proposed Design ChangeAccrual to the phase 2 studies has been slower than expected. Reasons: start up for centres, increasing use of prior chemotherapy in preference to hormonal agent. Consider allowing either hormonal OR chemotherapy as the control arm for this study.

  • SchemaSample size: Approximately 460 patientsArm 2:medroxy progesterone 200 mgor megestrol 160 mg (as per local practice) po dailyChemotherapy optionsSurvivalfollow-upDiseaseprogressionImagingq 8 weeksArm 1: ridaforolimus 40 mg po days 1-5 each week

    RANDOMIZEWomen with recurrent or metastatic endometrial cancer1-2 Prior Chemotherapy

  • Carcinosarcoma GOG0261: Randomized Phase III Trial of Carboplatin plus Paclitaxel versus Ifosfamide plus Taxol in Patients with Advanced, Persistent or Recurrent Carcinosarcoma NCRI, GINECO, JGOG, RTOG

  • LeiomyosarcomaGOG0250: Randomized Phase III Evaluation of Docetaxel, Gemcitabine, & G-CSF +/- Bevacizumab in the Treatment of Recurrent or Advanced Leiomyosarcoma

  • GTNCharge from the ExecutiveRFPISSTD

  • GTD ConceptsHydatidiform Mole Registry (Quinn)

    Pulse Act-D vs. 8 day MTX for Low Risk GTN

    *