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Gynae Clinical Trial List
OPEN TRIALS
Patients
Study status
46 patients recruited
24 remain on follow up for life
All patients were included in the
Chorus phase 3 study.
13587 patients
Follow up phase until end of 2011
Has been an interim analysis which is
promising
Phase 1 completed by genetic nurses
and Dr Morrison
Phase 2 requires 4 mthly Ca125 tests
and potential CT scans so ovarian
cancer research nurses now involved
CHORUS
A Randomised Feasibility Trial to Determine the Impact of Timing of
Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced
Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
UKCTOCS
UK Collaborative Trial of Ovarian Cancer Screening
UKFOCSS
United Kingdom Familial Ovarian Cancer Screening Study
80 in phase 1
44 returned their consent forms for
phase 2
CLOSED TRIALS
ASTEC
A randomised trial of lymphadenectomy and of adjuvant external beam
radiotherapy in the treatment of endometrial cancer
87 patients recruited
76 remain on follow up 10 yrs post
randomisation
“Efficacy of systemic pelvic
lymphadenectomy in endometrial
cancer (MRC ASTEC trial): a
randomized study” The Lancet Vol
373 Jan 10, 2009
CE04
A Randomised Phase III Study of Chemotherapy and Radiotherapy
versus Radiotherapy Alone as Adjuvant Treatment to Patients with
Node Positive Stages IB or IIA Cervix Cancer
1 remains on follow up
DNA Methylation
DNA Methylation as a predictor for response and progression-free survival
in patients with ovarian cancer
5 patients recruited
No follow up
EORTC 55984
Randomised Trial of Adriamycin (A) Cisplatin (P) Chemotherapy Vs
Paclitaxel (T) Adriamycin (A) and Cisplatin (P) In Patients With
Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer
5 patients recruited
Follow up until disease progression
Totally closed and archived
EORTC 55991
A Randomised Trial Of Adjuvant Treatment With Radiation Plus
Chemotherapy Versus Radiation Alone In High Risk Endometrial
Carcinoma
10 patients recruited
9 remain on follow up to 5 years post
randomisation
Novartis Patupilone (EPO906)
A randomized, parallel group, open-label, active controlled, multi-centre
phase 3 trial of Patupilone (EPO906) versus pegylated liposomal
doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant
patients with recurrent epithelial ovarian, primary fallopian or primary
5 patients recruited
1 remains on treatment – Patupilone
3 on follow up for 5 years post
treatment
Recruitment closed
Awaiting interim analysis
0 patients recruited
Took over two years to open we ran
out of time to recruit
peritoneal cancer.
ICON 7
A randomised, two-arm, multi-centre Gynaecologic Cancer InterGroup
trial of adding bevacizumab to standard chemotherapy (Carboplatin and
Paclitaxel) in patients with epithelial ovarian cancer.
SCOTROC
A randomised, prospective Phase III comparison of Paclitaxel /
Carboplatin vs Docetaxel / Carboplatin as first line chemotherapy in
36 patients recruited
7 remain on follow up for life
stage Ic-IV epithelial ovarian cancer
SCOTROC 2
A Randomised, feasibility study of sequential carboplatin followed by
Docetaxel alone or Docetaxel / Gemcitabine as first-line chemotherapy for
stage IC-IV ovarian, fallopian tube and primary peritoneal carcinomas.
15 patients recruited
4 remain on follow up for life
SCOTROC 3
A Phase 1b Trial of Docetaxel/Carboplatin Administered in
Combination with Oral Doses of TarcevaTM to Patients with
Newly Diagnosed/ Previously Untreated Epithelial Ovarian
Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer
SCOTROC 4
A Prospective, Multi-centre, Randomised Trial of Carboplatin Flat Dosing
vs Intrapatient Dose Escalation In First Line Chemotherapy of Ovarian,
13 patients recruited
7 on follow up for life
Fallopian Tube and Primary Peritoneal Cancers
SCOTROC 5
A feasibility study of sequential Carboplatin followed by
Paclitaxel/Gemcitabine as first line chemotherapy for Stage IC-IV ovarian,
fallopian tube and primary peritoneal carcinomas.
0 recruited
Recruitment completed when we
finally opened
TLK286
Phase III Randomised Study of TLK286 versus Doxil/Caelyx or
Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant
Ovarian Cancer
2 patients recruited
0 on follow up
UK-OPS
769 patients recruited
Follow up by co-ordinating centre
Risk prediction and early detection of ovarian cancer.
Totally closed and archived
PENDING
PENDING NICCTU APPROVAL
Portec 3
Randomised Phase III Trial Comparing Concurrent Chemoradiation
and Adjuvant Chemotherapy with Pelvic Radiation Alone in High
Risk and Advanced Stage Endometrial Carcinoma
Not open to recruitment yet
PENDING NICCTU Presentation
CHORUS Phase 3 study
Chemotherapy Or Upfront Surgery. A Randomised Feasibility Trial
To Determine The Impact OF Timing Of Surgery And Chemotherapy
In Newly Diagnosed Patients With Advanced Epithelial Ovarian,
Primary Peritoneal Or Fallopian Tube Cancer
MORPHOTEK
A Randomised, double-blind, placebo-controlled, phase 3 study to
assess the efficacy and safety of weekly Farletuzumab (MORAb-003)
in combination with Carboplatin and Taxane in subjects with
Platinum-sensitive ovarian cancer in first relapse
Feasibility patients included in the
main study
Awaiting NICCTU presentation
OK to continue recruiting under
feasibility study
Awaiting NICCTU presentation