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Cancer Services - North Bristol NHS Trust

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Cancer Services - North Bristol NHS Trust ...

    CANCER CLINICAL TRIALS UNIT

    Cancer Services

    Somerset House, Southmead Hospital

    Westbury-on-Trym

    Bristol BS10 5NB

Issue No. ISSUE 7

     APRIL 2006 (COVERS OCT/NOV/DEC/JAN/FEB/MAR)

    CLINICAL TRIALS PORTFOLIO

    APRIL 2006

Andrew Harvey NCRN Research Nurse 77 / 5292

Catharine Dawe Breast Cancer Research Nurse 78 / 3492

Dr Mike Shere Breast Cancer Trials Lead Clinician 78 / 3495

Tricia O‟Sullivan ProtecT Research Nurse 77 / 5080

Marilyn Calder Pittsburgh Study Research Nurse 76 / 4551

Dr Sivaprakasam Urology Clinical Research Fellow 77 / 4551

    Sivalingam

Any correspondence regarding the Clinical Trials Portfolio, please contact Andrew Harvey (Network

    Research Nurse Andrew.Harvey@nbt.nhs.uk)

    North Bristol Trust page 1 / 18 Clinical Trials List

    *** IMPORTANT NOTICE ***

All the trials that feature in this list are run from NBT,

    there are many other trials run from the Oncology

    Centre (see attached list) onto which patients can be

    referred.

NEW STUDIES OPEN SINCE LAST PORTFOLIO (3)

    ? BBC

    ? GB07 ? 3D ULTRASOUND

NUMBER OF ACTIVE STUDIES (22)

POTENTIAL TRIALS IN SET-UP PROCESS (9)

    ? FEM345

    ? SOFT

    ? TEXT

    ? REACT

    ? STUDIES OF THE PROPERTIES OF NORMAL VERSUS

    BLOOD CANCER OR LEUKAEMIA STEM CELLS

    ? WATCH & WAIT

    ? MAPS

    ? MEDPULSER

    ? BTOG2

STUDIES CLOSED SINCE LAST TRIALS LIST (3)

    ? AZURE ? PIMMS ? TEAM (re-opened and now closed)

North Bristol Trust page 2 / 18 Clinical Trials List

    BREAST

    AZURE CLOSED AZURE Does Adjuvant Zoledronic Acid Reduce Recurrence in Patients with High Risk

    Localised Breast Cancer

NCRN Approved

    Key Eligibility Female patients with Stage II or III primary breast cancer who are scheduled to receive (neo)adjuvant chemotherapy and/or (neo)adjuvant hormonal therapy and have had

    or are scheduled to proceed to definitive surgery and/or radical radiotherapy

Patients entered this financial year (2005/2006): 3

    Total number of patients entered: 9

Closing date Autumn 2006

Contact: Dr Mike Shere

     Andrew Harvey BRITISH BREAST CANCER STUDY-

    A national population-based study of treatment effect and endocrine, genetic and cellular risk

    factors for contralateral primary breast cancer in women in Britain.

    Key Eligibility women with breast cancer (unilateral or bilateral) aged under 70

Patients entered this year (2005/2006): 88

    Total number of patients entered: 88

Closing date 2007

Contact: Dr Mike Shere

     Andrew Harvey

    COMICE Aim is to determine potential benefits of the addition of MRI to routine techniques employed

    for loco-regional staging of primary breast cancer.

NCRN Approved

    Key Eligibility Patients scheduled for a wide local excision.

Patients entered this year (2005/2006): 47

    Total number of patients entered: 154

Closing date Jan 2007

Contact: Dr Mike Shere

     Catharine Dawe

    North Bristol Trust page 3 / 18 Clinical Trials List

DCIS-II TRIAL

    Randomised trial testing observation (no radiotherapy) against radiotherapy in women with

    low-risk completely excised ER positive ductal carcinoma in situ (DCIS) of the breast on

    adjuvant endocrine therapy.

NCRN Approved

    Key Eligibility Unifocal DCIS without an invasive component. Patients with microinvasion (defined as one or more foci of invasion each <1mm) may be included. Complete microscopic

    excision with a MINIMUM radial margin of 1 mm, confirmed by specimen x-ray. ER +ve or

    PgR +ve (either > 10% tumour cells staining for receptor or a cutpoint of > 2). Maximum

    microscopic tumour diameter must be < 30 mm (< 15 mm if grade 3). Primary surgery within 6

    months of randomisation.

Patients entered this year (2005/2006): 0

    Total number of patients entered: 0

Closing date 2010

Contact: Dr Mike Shere

     Catharine Dawe FH01

    FH01 - HTA Mammography Trial Evaluation of mammographic surveillance services in

    women under 50 with a family history of breast cancer.

NCRN Approved

Key Eligibility - Data will be collected on women between the age of 40 and 49 offered annual

    mammography (recruited at ages 40-44 to ensure that each subject contributes five years of

    observation below age 50) who have a family history of breast cancer.

Patients entered this year (2005/2006): 28

    Total number of patients entered: 145

Closing date December 2008

Contact: Dr Mike Shere

     Andrew Harvey

    GB07

    Commercial Breast Trial from NOVARTIS

    Commercial Study NOT NCRN Approved

Patients entered this year (2005/2006): 1

    Total number of patients entered: 1

Closing date Unknown

Contact: Dr Mike Shere

     Catharine Dawe

North Bristol Trust page 4 / 18 Clinical Trials List

IBIS-II (Prevention)

    To determine if anastrozole is an effective method of preventing breast cancer in

    postmenopausal women at increased risk of the disease. To also evaluate the S/E‟s of

    anastrozole.

NCRN Approved

    Key Eligibility Postmenopausal women between 40 and 70 with an increased risk of breast cancer (family history, previous benign disease with evidence of proliferation, mammographic

    dysphasia, and nulliparity).

Patients entered this year (2005/2006): 30

    Total number of patients entered: 126 consented

Closing date (Planned) 2007

Contact: Dr Mike Shere

     Catharine Dawe

    IBIS-II (DCIS) To determine if anastrozole is at least as effective as tamoxifen in local control and prevention

    of contralateral disease in women with locally excised DCIS. To compare S/E profiles of

    tamoxifen and anastrozole.

NCRN Approved

    Key Eligibility Women with locally excised DCIS diagnosed in the last 6 months, in which there are tumour free margins of at least 5mm.

Patients entered this year (2005/2006): 3

    Total number of patients entered: 5

Closing date (Planned) 2007

Contact: Dr Mike Shere

     Catharine Dawe

    OPTION

    Ovarian Protection Trial In Oestrogen Non-responsive Premenopausal Breast Cancer

    Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy

NCRN Approved

Key Eligibility - Histologically confirmed invasive, early operable or locally advanced breast

    cancer, stages I-IIIB (with N0-2) . Complete excision of primary tumour, if being considered

    for adjuvant chemotherapy. Premenopausal with regular menses in the 12 months up to time

    of surgery

Patients entered this year (2005/2006): 1

    Total number of patients entered: 1

Closing date March 2007

Contacts: Dr Shere

     Catharine Dawe

North Bristol Trust page 5 / 18 Clinical Trials List

PIMMS CLOSED

    PIMMS A psycho-social evaluation of the impact of mammographic surveillance services on

    women under 50 at increased risk of inherited breast cancer.

NCRN Approved

Key Eligibility - High/moderate risk of inherited breast cancer, Aged 40-49. Without a

    previously diagnosis of breast cancer.

Patients entered this year (2005/2006): 77

    Total number of patients entered: 198

Closing date March 2006

Contact: Dr Mike Shere

     Andrew Harvey

    POSH

    Prospective study of Outcomes of treatment in Hereditary versus Sporadic breast cancer

NCRN Approved

Key Eligibility - All women diagnosed with invasive breast cancer at 40 years or younger in all

    participating centres

Patients entered this year (2005/2006): 5

    Total number of patients entered: 40

Closing date June 2006

Contact: Dr Mike Shere

     Catharine Dawe

    PRIME II

    Post-operative Radiotherapy In Minimum-risk Elderly Phase II

NCRN Approved

Key Eligibility - Breast conserving surgery with an excision margin of a minimum of 1mm on

    histological assessment, size 3cm or less, ER or PR +ve and treated with adjuvant endocrine

    therapy, N0.

(Radiotherapy given at Bristol Haematology and Oncology Centre-therefore patients included

    in their figures also)

Patients entered this year (2005/2006): 1

    Total number of patients entered: 3

Closing date End 2007

Contacts: Dr Shere

     Catharine Dawe

    North Bristol Trust page 6 / 18 Clinical Trials List

    SOFEA SoFEA Study of Faslodex with or without concomitant Arimidex vs Exemestane following

    progression on non-steroidal Aromatase inhibitors

NCRN Approved

Key Eligibility - Female postmenopausal patients. Histologically or cytologically confirmed

    adenocarcinoma of the breast. Patients with original ER+ve and/or PgR+ve breast cancer

    which has relapsed or progressed during endocrine therapy with a single agent non-steroidal

    aromatase inhibitor (NSAI). Measurable / evaluable sites of metastatic disease (Response

    Evaluation Criteria in Solid Tumours - RECIST).

Patients entered this year (2005/2006): 0

    Total number of patients entered: 0

    Closing date 2007

Contacts: Dr Shere

     Catharine Dawe

    TEAM CLOSED TEAM An open label, randomised, multicentre, comparative trial of 5 years adjuvant

    Exemestane treatment versus adjuvant tamoxifen followed by Exemestane in

    postmenopausal women with early breast cancer.

NCRN Approved

Key Eligibility - Women with histologically confirmed primary adenocarcinoma of the breast

    who have undergone potentially curative surgery and meet the following criteria and are

    postmenopausal. Estrogen receptor (ER) and /or Progesterone receptor (PgR) positive

    tumour. Any tumour with size > 3cm or Any N+ or tumour size 1-3 cm, N0 Plus any of the

    following

(This trial re-opened in March 2005 these figures only reflect the new trial)

Patients entered this year (2005/2006): 27

    Total number of patients entered: 27

    Closing date March 2006

Contacts: Dr Shere

     Catharine Dawe North Bristol Trust page 7 / 18 Clinical Trials List

3D ULTRASOUND

    Evaluation of a new 3-D Ultrasound Machine - To evaluate a novel 3-Dimensional Ultrasound

    Machine developed in Bristol and Bath. The hope is that this will not only give good 3-

    dimensional slice views but make ultasound more reproducible

NOT NCRN Approved

Key Eligibility - Any woman with a breast cancer visible with handheld ultrasound

Patients entered this year (2005/2006): 3

    Total number of patients entered: 3

Closing date 31/12/2006

Contacts: Dr Shere

    North Bristol Trust page 8 / 18 Clinical Trials List

    COLORECTAL

NSCCG

    National Study of Colorectal Cancer Genetics

NCRN Approved

Key Eligibility - Patients who are undergoing or have undergone surgical treatment for

    colorectal cancer in the last five years who remain alive and recurrence-free. Controls will be

    non-blood relatives or friends of cases.

Patients entered this year (2005/2006): 30 patients / 4 controls

    Total number of patients entered: 77 patients / 10 controls

Closing date 2007

    Contacts: Mr Roe

     Andrew Harvey North Bristol Trust page 9 / 18 Clinical Trials List

     HAEMATOLOGY

MERIT

    MyEloma Renal Impairment Trial - A randomised controlled trial of adjunctive plasma

    exchange in patients with newly diagnosed multiple myeloma and acute renal failure

NCRN Approved

Key Eligibility Newly diagnosed myeloma and acute renal failure (unresponsive to up to 72h

    of rehydration and bisphosphonate treatment of hypercalcaemia),

Patients entered this year (2005/2006): 1

    Total number of patients entered: 2

    Closing date June 2008

Contact: Dr Janet Birchall

     Andrew Harvey Myeloma IX

    Myelomatosis therapy trial for patients of all ages. A randomised trial comparing second

    generation vs third generation bisphosphonates, induction chemotherapy regimens (CVAD vs

    CTD, and MP vs CTDa) and thalidomide maintenance vs no maintenance therapy.

NCRN Approved

Key Eligibility - Newly diagnosed symptomatic multiple myeloma or non-secretory multiple

    myeloma: - Paraprotein (M-protein) in serum and/or urine - Bone marrow clonal plasma cells

    or plasmacytoma - Related organ or tissue impairment. Prepared to use contraception5.

    Negative pregnancy test

Patients entered this year (2005/2006): 2

    Total number of patients entered: 2

    Closing date March 2008

Contacts: Dr Sophie Otton

     Andrew Harvey

North Bristol Trust page 10 / 18 Clinical Trials List

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