ATTom study Design

By Clyde Ortiz,2014-06-26 19:40
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ATTom study Design ...

    ATTom study Design

    ATTom Adjuvant Tamoxifen Treatment offer more?

ATTom is a very large, uniquely simple randomised study of the effects of prolonging

    adjuvant tamoxifen on the survival of patients with operable breast cancer

     Breast carcinoma completely excised Any primary treatment At least 2 years prior tamoxifen treatment Clinically relapse free

     Is further Tamoxifen

    indicated at this time? Definitely Definitely

    NO YES

    Patient is Reconsider

    NOT randomisation

    Eligible later UNCERTAIN

     whether to continue or not



    tamoxifen for a further 5

     now years

    Exclusion Criteria: Eligibility Criteria:

    Definite contraindications to tamoxifen are not Any woman who is clinically relapse free, and who

    specified by the protocol, is currently taking tamoxifen can join the aTTom

    but might include: study.

    Intended or actual pregnancy or breastfeeding The patient is eligible if there are thought not to be

     Significant endometrial hyperplasia any clear indications for or definite contraindications

    Retinopathy against further tamoxifen, and hence substantial

    Need for anti-coagulant therapy. uncertainty exists at to stop or continue treatment.

    Serious toxicity (eg. Depression) thought due to

    tamoxifen Women who have received any type of initial

     or surgery who have received any other type of

    Negligibly low risk of breast cancer death adjuvant treatment are eligible for aTTom. Women

    Some major life threatening disease other than breast may have node positive or node negative disease, be

    cancer (such that management of breast cancer is not pre or post-menopausal, and have ER positive or ER

    the main concern) negative tumours, etc.

    Low probability of treatment compliance (eg.

    psychiatric disorders, or extreme old age).

     SECRAB Study Design

    SEquencing of Chemotherapy and Radiotherapy in Adjuvant Breast cancer

A large randomised clinical trial designed to determine the optimum sequencing of

    chemotherapy and radiotherapy in the adjuvant treatment of early breast cancer

     Women with early breast cancer having adjuvant chemotherapy

     and radiotherapy following

     conserving surgery or


     Confirm eligibility

    Prescribe appropriate CT and RT regimens

     Decide if a Boost dose will be given

     Obtain informed consent


     Sequential Schedule Synchronous Schedule

    Chemotherapy followed Chemotherapy

     Radiotherapy by Radiotherapy Chemotherapy

     Annual follow-up for five years (relapse and survival status)

Eligibility Criteria:

     Histological diagnosis of invasive, unilateral breast carcinoma.

Wide local excision or mastectomy with macroscopic complete excision of clinically early stage

    disease with no evidence of metastases.

There is a clear indication for both adjuvant chemotherapy and radiotherapy, or the patient has been

    randomised to these treatments in another study.

The intended schedules can be given synchronously and the patient is suitable for either treatment


     No prior chemotherapy (other than hormone manipulation).

     No prior malignancy (except skin basal/squamous cell or in situ carcinoma).

     No other medical or social contraindication to entry and follow-up.

    DEVA Study Design

Sequential Epirubicin & Docetaxel vs Epirubicin alone in postmenopausal primary breast cancer

     Eligible patients Post-menopausal Node positive breast cancer No distant metastases Completely resected


    EPIRUBICIN 50mg/m22 EPIRUBICIN 50mg/m Day 1 & Day 8 Day 1 and Day 8 6x cycles 4-weekly 3x cycles 4-weekly Followed by: 2 DOCETAXEL 100mg/m

    Day 1

    3x 3-weekly cycles

     *TAMOXIFEN (sequential vs concurrent)

    Centres not partaking in

    sequential vs concurrent


     Sequential Concurrent Concurrent tamoxifen for Tamoxifen tamoxifen for 5 years for 5 years 5 years

    Follow up prior to each course of chemotherapy, and months 9 & 12. Then

    months 16, 20, 24, 30, 36, 42, 48, and annually thereafter

     Eligibility Criteria: Postmenopausal, histologically proven node positive breast cancer

    No evidence of metastases

    WHO performance status 0 or 1 & Biochemistry within normal limits:

    WBC? 3x10

    99/l or ANC?1.5 x 10/l 9Platelets ? 100 10/l

    Normal Bilirubin

    SCGOT, SGPT and alkaline phosphatase ? 1.5 x normal, serum Creatinine <1.5 x normal.

    (for patients allocated to epirubicin followed by docetaxel, the LFTs should be checked again

    prior to commencing treatment with docetaxel) No significant cardiac disease (ECG and/or LVEF by MUGA scan/echocardiography). Centres

    should inform the Data centre of the type of assessment intended for all patients randomised

*For ER- & PgR- patients, tamoxifen treatment id according to discretion of the clinician.

    FOCUS Study Design

    Fluorouracil, Oxaliplatin and Irinotecan: Use and Sequencing

    A randomised trial to assess the role of irinotecan and oxaliplatin in advanced colorectal


     Eligible patient: advanced colorectal cancer, not previously Randomise treated with chemotherapy for metastatic disease

     Plan A Plan B Plan C Plan D Plan E

     MdG MdG IrMdG MdG OxMdG until

    until until until until progression

    progression progression progression progression

     Second-line Second-line Second-line

     single agent IrMdG OxMdG irinotecan

    Upon progression, management at the clinician’s discretion, usually supportive care alone. If further

    chemotherapy is to be used, use a non-crossover regimen. PVI 5FU + mitomycin is recommended

    Abbreviations: MdG Modified de Gramont

     IrMdG Modified de Gramont + irinotecan

     OxMdG Modified de Gramont + oxaliplatin

    Eligibility Criteria: Exclusion Criteria:

    Histologically confirmed adenocarcinoma of the colon or Concurrent uncontrolled medical illness, or other rectum current malignant disease likely to interfere with Inoperable metastatic or locoregional disease protocol treatments or comparisons No previous chemotherapy for established metastatic Partial or complete bowel obstruction disease (if adjuvant chemo was give previously, it may Age<18. No fixed upper age limit, use precaution in have included 5FU but not oxaliplatin or irinotecan, and selection of elderly patients must have been completed >6months prior to trial entry) Pre-existing neuropathy (>grade1) Measurable disease (RECIST classification) Chronic diarrhoea or inflammatory bowel disease 99WBC>4 x10/l, platelet count >150 x 10/l, Bilirubin Gilbert’s Syndrome or other congenital abnormality of <1.25 upper limit of normal(ULN) and ALP<5 x ULN biliary transport GFR>50ml/min Previous transplant surgery, requiring WHO PS 0, 1 or 2 immunosuppressive therapy (due to interaction of WOCBP negative pregnancy test & adequate contraceptive cyclosporin-A with irinotecan precautions Unable to comply with QoL assessment

    VICTOR Study Design

    VIOXX in Colorectal Cancer Therapy: definition of Optimal


    Randomised, double blind, placebo-controlled study or Rofecoxib (VIOXX)

    in colorectal cancer patients following potentially curative therapy

    Patient fulfils eligibility criteria



    2 years 5 years 2 years 5 years

    Eligibility Criteria: Exclusion Criteria:

Histologically proven Dukes C (stage III: any T, N, Patients with active peptic ulceration or GI 1-2

    M or B (stage II: T or , N, M) colorectal bleeding in the last year 0) 3400

    carcinoma Past history of adverse reaction to NSAID eg. Patients must have undergone complete resection of Asthma, acute rhinitis, nasal polyps, angioneurotic the primary tumour without gross or microscopic oedema or urticaria evidence of residual disease Known sensitivity to VIOXX WHO PS 0 or 1 Long-term NSAID therapy (except low dose 99ANC?x 10aspirin) /l, platelets >100 x 10/l, Bilirubin

    <18 years of age AST/ALT 1.5 x upper limit of normal,

    Pregnancy or lactation GFR>30ml/min. Tests to be carried out ? 2 weeks

    Previous malignancies other then adequately prior to randomisation

    treated in situ carcinoma of the uterine cervix or Within 12 weeks of finishing potentially curative

    basal or squamous cell carcinoma of the skin, therapy (surgery alone, or surgery + Radiotherapy

    unless there has been a disease free interval for at +/- Chemotherapy

    least 10 years

    Inflammatory bowel disease

    Severe congestive heart failure

    GELCAPS Study Design

    Genetic Lung Cancer Predisposition Study

     Patients diagnosed with lung Partner of patient cancer (wherever possible)

     Lifestyle questionnaire

    Blood sample taken for

    analysis at trial centre

All patients who have been diagnosed with lung cancer, irrespective of whether

    the patient smokes are eligible. (Adenocarcinoma must be histologically proven

    from bronchial biopsy or surgical resection)

    NSCLC must be specified cell type eg. Squamous

    Patients may enter the study at any time after diagnosis

The partner of the patient includes spouse, same sex partner or other

    unrelated adult living long term in the same house as the patient.

The partner must not have developed a smoking related malignancy

Smoking and non-smoking partners are eligible for entry into the study

    9At the time of sampling, the patient must have WBC at least 2x10/l. It is

    not necessary to routinely check the partners’ WBC

It is vital for the success of GELCAPS that a group B partner is

    recruited to GELCAPS wherever possible

    MESO-1 Study Design

    Randomised feasibility study of active symptom control with or without chemotherapy in the treatment of

    patients with mesothelioma

    Patient with diagnosis of mesothelioma



    YES NO

    No further information is

    Randomise required regarding this patient

     ASC ASC + MVP ASC + N

    Patients are followed up every 8 weeks until death.

    QoL should be completed by every patient - prior to being informed of their allocated treatment

ASC: Active symptom control 222MVP:Mitomycin (8 mg/m), vinblastine (6mg/m) and cisplatin (50 mg/m) to be given every 21

    days with a total of 4 cycles 2N: 6 weekly injections of vinorelbine (30 mg/m) followed by a 2-week interval before a further

    course of 6 weekly injections

Eligibility criteria:

Microscopically and immunohistochemically confirmed malignant mesothelioma, including

    epithelial and other histological types.

    Any symptomatic pleural effusion treated and brought under control by drainage, pleurodesis

    or pleurectomy before trial entry.

    CT scan to be performed within a month prior to randomisation and, wherever possible, after


    Patients who have undergone surgical resection of mesothelioma are eligible provided 2 CT

    scans, 6 weeks apart; show stable or progressive disease which is assessable.

    No previous chemotherapy for mesothelioma.

    No other disease or previous malignancy likely to interfere with protocol treatments or


    WHO status 0-2.


    999/l, neutrophils>1.5x10/l, platelets>100x10/l, and there is no clinical evidence of infection.

    Considered medically fit to receive chemotherapy.

    Patient has completed QoL forms prior to being informed of treatment allocated.

    MALCS Study Design

A population based case-control study of mesothelioma and lung cancer in

    relation to occupation among British men and women under the age of 60

     Mesothelioma & resected lung cancer patients aged under

    60 years

     Obtain informed consent

    Telephone interview conducted by Institute of Cancer research

    Lung sample obtained post


     All mesothelioma & resected lung cancer patients aged 60 years, registered with a GP

Not to have worked outside the UK for longer then 1 year (except members of the Armed Forces, who will be included regardless of where they were stationed) this doesn’t include living abroad as a child.

    Telephone owners (not ex-directory)

     GP informed & permission sought for patients’ inclusion. Telephone interviews are conducted by researchers at the Institute of Cancer


     Post mortem lung samples will be provided by relevant pathologist to trial centre & examined for fibre content

    LU22 Study Design

    Randomised trial of surgical resection with or without pre-operative

    chemotherapy in patients with operable non-small cell lung cancer (NSCLC) or

    any stage

    Resectable NSCLC

    First QoL form completed


     Surgery Chemotherapy & surgery

    Chemotherapy schedules:

MVP: Vinblastine 6mg/m

    , and cisplatin 50mg/m at 3-week intervals for 3 cycles, 22

    with Mitomycin 8 mg/2

    MIC: Same as MVP but with ifosfamide 3g/m instead of vinblastine 2

NP: Vinorelbine (Navelbine) 30 mg/m on days 1 and 8 and cisplatin 80 mg.m on 22

    day 1 at 3-week intervals for 3 cycles

     Eligibility Criteria: Previously untreated NSCLC, microscopically proven from biopsy or cytology Tumour considered resectable by surgeon No evidence of distant metastases No contra-indication to chemotherapy or surgery No disease or previous malignancy likely to interfere with the protocol treatments or comparisons. Clinical and CT staging for all patients Mediastinoscopy for patients with possible N2 or T3N1 disease on CT scan. Then, only patients with pN0 or single-station nodal involvement should be considered.

     POSH Study Design

    Prospective Outcomes in Sporadic vs. Hereditary breast cancer

     Patient is ?40 years old Invasive breast cancer

     Check eligibility

    Obtain informed consent

     Blood sample is taken & sent to Fresh tumour sample sent to trial centre for DNA analysis trial centre if patient has (before surgery if possible) strong family history


     Representative pathology

     Family history questionnaire block sent temporarily to trial

     completed centre if no fresh sample


    Follow-up questionnaires at 6 and 12 months, then annually


Neither patients nor clinicians will be informed of patients’ BRCA status. Patients

    who wish to have genetic counselling may be referred to:

     Dr Fiona Douglas

     Consultant Clinical Geneticist

     Institute of Human Genetics

    International Centre for Life

    Central Parkway

    Newcastle upon Tyne

    NE1 3BZ

    Tel 0191 2418725

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