GCIG Cervix Committee: Chicago, USA May 30th Satoru Sagae (JGOG) Bradley Monk (GOG)

Transcription

1 GCIG Cervix Committee: Chicago, USA May 30th 2013 Satoru Sagae (JGOG) Bradley Monk (GOG)

2 Conflict of Interest Disclosures

3 CURRENT ACTIVE/NEAR ACTIVATION RANDOMIZED TRIALS WITH GCIG PARTICIPATION:

4 Wellcome to TACO! TACO GCIG/KGOG1027/TGCS2012: Randomized Phase III Clinical Trial Comparing Weekly vs Tri-weekly Cisplatin Based Concurrent Chemoradiation in Locally Advanced Cervical Cancer Sang Young Ryu, MD

5 TACO (Tri-weekly Administration of Cisplatin in LOcally Advanced Cervical Cancer) Cervical cancer Locally advanced cervical cancer Stage IB2, IIB-IVA Randomization Control Arm; Weekly Cisplatin 40mg/m2 6 cycles Study Arm; Tri-weekly Cisplatin 75mg/m2 3 cycles

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7 OUTBACK A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone Study Chair: Linda Mileshkin Study Coordinator: Ilka Kolodziej

8 Schema

9 Monthly Recruitment total 171pts 20 Accrual per Month Participants Months

10 INduction ChemoThERapy in Locally Advanced CErvical Cancer INTERLACE Mary McCormack for the NCRI Gynaecological Clinical Studies Group Chicago, 2013

11 INTERLACE Randomise Carboplatin AUC2 & Paclitaxel 80mg/m 2 Weeks 1-6 Weeks 7 13 Standard CRT Standard CRT Standard CRT : Gy in fractions plus Intracavitary brachytherapy to give total EQD2 dose of 78-86Gy to point A/volume. Weekly cisplatin 40mg/m 2 x 5 weeks Follow-up 3 monthly for 2 years; 6 monthly for 3 years

12 Current Status - UK 1 st Site initiation October 2012 UCLH Christie Manchester now open 4 patients recruited out of target 770 pts 3 further sites completed all trial set-up activities and awaiting final RT QA approval 37 Sites in general trial set-up 15 further Sites expressed interest TOTAL = 56 Sites

13 A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION IN PATIENTS WITH LOW-RISK, EARLY- STAGE CERVICAL CANCER A Gynecologic Cancer Intergroup (GCIG) Trial led by the NCIC CTG GCIG Trial Designation: The SHAPE Trial NCIC CTG Protocol Number: CX.5 Chair: Marie Plante

14 Trial Schema 12 weeks 8 weeks 4 weeks Diagnostic Procedure MRI Chest Scan PRO Hx/PE Randomization Surgery Adjuvant chemoradiation (if necessary) Follow-up

15 Current Status Aug Trial was activated in Canada Dec First patient randomized April patients enrolled 8 centres in Canada activated 10 international cooperative groups are actively seeking funding/approval to participate

16 CCRN PART Summary 1. TACO trial looking to be successful 2. OUTBACK trial accrual increasing ANZGOG, GOG 3. INTERLACE, SHAPE just started, but lots of hurdles in developing countries How to activate CCRN in the developing countries? simple trial is best, site visits different national status; infrastructure, funding, regulatory authorities, harmonization resources Speed up support for developing countries, especially QC,QA of radiation therapy Educational session at IGCS 2014 (Quinn M)

17 Gynecologic Oncology Group Bradley J. Monk, MD, FACS, FACOG Chair GOG Cervical Cancer Committee Professor and Director Division of Gynecologic Oncology St. Joseph s Hospital and Medical Center, a Dignity Health Member Phoenix, Arizona USA bradley.monk@chw.edu

18 Gynecologic Oncology Group Current GCIG Studies in the GOG 1. GOG 263 (KGOG) 2. GOG 0724 (RTOG) 3. GOG 0274 (ANZGOG) 4. GOG 233 (ACRIN) 5. TIME-C (RTOG) 6. GOG 270 (GROINSS-V II)

19 GOG 263/KGOG 1008 PI; Sang Young Ryu, MD Randomized Phase III Clinical Trial of Adjuvant Radiation vs Chemoradiation In Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy Control Arm; Radiation therapy Cervical cancer Stage I-IIA Radical hysterectomy+bplnd >2 of intermediate risk factors Randomization CRT Arm; Weekly CDDP 40mg/m 2 concurrent to radiation

20 Eligibility Criteria (GOG 263=GOG 92)

21 Accrual of GOG /480pts Global Global

22 Gynecologic Oncology Group New Studies in the GOG 1. GOG 278 (opened Sept 20, 2012) 2. GOG 279 (opened Nov 2, 2012)

23 Study Chair: A Covens GOG 278

24 GOG 279 Study Chair: NS Horowitz Target 52 evaluable patients

25 Gynecologic Oncology Group Cervical cancer will be highlighted Sunday at the Plenary Session Abstract #2 2:20 PM - 2:35 PM Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India. Surendra S. Shastri, MD Abstract #3 2:50 PM - 3:05 PM Incorporation of bevacizumab in the treatment of recurrent and metastatic cervical cancer: A phase III randomized trial of the Gynecologic Oncology Group (Protocol 0240). Krishnansu S. Tewari, MD

26 GOG233-ACRIN6671 Locoregionally advanced cervical cancer (Stages IB2, IIA 4 cm, IIB-IVA) or High risk endometrial cancer, i.e. grade 3 endometrioid, clear-cell, serous papillary, carcinosarcoma or grade 1 or 2 endometriod carcinoma with cervical stromal involvement Fusion PET-CT scan of the chest, abdomen and pelvis CT to be performed with oral and intravenous contrast No disease outside of the abdominopelvic nodes Evidence of disease outside of the abdominopelvic nodes Advanced lymphadenopathy not amenable to surgery Pelvic & para-aortic lymphadenectomy Negative bx Biopsy distant disease

27 GOG233-ACRIN6671 Michael Gold (GOG), Mosta Atri (ACRIN) Activated for invasive cervix September 2007 Amended to expand to endometrial January 2010 US, Korea, Canada & Japan 24/27 open sites actively accruing Cervical Endometrial Total Target accrual Accrued so far 165 >210 >375 Projected accrual completion October 2013 June 2014

28 RTOG-0724 (GOG): ChemoRT with and without adjuvant chemotherapy in high risk cervix cancer after hysterectomy Accrual: <100/400 International participation will be expected: RTOG, GOG, KGOG, Canada

29 A RANDOMIZED PHASE III STUDY OF STANDARD VS. IMRT PELVIC RADIATION FOR POST- OPERATIVE TREATMENT OF ENDOMETRIAL AND CERVICAL CANCER (TIME-C) CO- PIS ANN KLOPP MD, PHD ANAMARIA YEUNG MD PRO AND QOL CO- CHAIR LARI WENZEL, PH.D. KAREN GIL, PH.D. COST ANALYSIS CO- CHAIR ANDRE KONSKI, MD, MBA, MA, FACR STATISTICIAN STEPHANIE SHOOK

30 Schema Eligibility Women with endometrial or cervical cancer requiring P postoperative pelvic radiation or chemoradiation Stratification factors XRT dose 45 Gy 50.4 Gy Chemotherapy No Chemotherapy 5 cycles P of weekly cisplatin at 40mg/m 2 Disease Site Endometrial Cervix R A N D OP M I Z E IMRT pelvic radiation P treatment 4-field pelvic radiation P treatment

31 Update GROINSS-V-II (DGOG) Update March 2013 Accrual: December 2005 February 2013 (n = 897)

32 Patient data Eligible: 834 Data missing: 184 Data available: 650 Sentinel node data 650 patients: 500 negative SN (77%) 150 positive SN (23%) Follow-up Local recurrences: 65 patients Groin recurrences after negative SN: 14/500 (2.8%) Groin recurrences after positive SN: 11/150 (7.3%) 2 protocol violations 9 according to protocol: 8 out of 9 with macrometastases in SN

33 Conclusions Omitting inguinofemoral lymphadenectomy in vulvar cancer patients with a negative SN is safe Stopping rule was activated for radiotherapy arm -> protocol amendment Sept 2010 Patients with SN metastases > 2mm: inguinofemoral lymphadenectomy Low number of positive SNs, compared to GROINSS-V-I 30% versus 20% Inclusion rate increases: Last 6 months about patients / 3 months! Final inclusion expected: end 2015 Results expected: end 2017

34 EORTC 55994: Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO stage Ib2, IIa > 4 cm or IIb cervical cancer. EORTC Study Coordinators: Dr. G. Kenter Dr. F. Landoni Dr. S. Greggi

35 Cervix Cancer. Treatment Scheme N=686 Eligibility Check Randomization EORTC Arm 1: Neoadjuvant QT Cisplatin based chemotherapy : -min. cumulative cisplatin dose of 225 mg/m 2-25 mg/m 2 per week, -final dose no later than D64 Followed by surgery (radical hysterectomy) Arm 2: concomitantly QT/RDT Cumulative cisplatin dose mg/m². - Max 6 administrations. - Dose 40 mg/m 2, max 80 mg External radiotherapy (45-50 Gy) in fractions of 1.8 Gy to 2 Gy + external boost or brachytherapy - min. 75 Gy EQD2 to point A (80 Gy to High Risk PTV) is mandatory - overall treatment time 50 days PIs: G. Kenter, S. Greggi, F. Landoni

36 EORTC Current status Activation of new sites: Germany, Spain, France, Ireland, Serbia, UK Recruitment continues to be slow (582/686 patients) This trial will reviewed by the EORTC HQ Executive Committee in Brussels next month.