Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Definitive surgery without preoperative AI treatment

Treatment with letrozole for 4 months before definitive surgery.

letrozole (Femara)

Bent Ejlertsen, MD, PhD

The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

The Danish Medical Research Council

Danish Cancer Society

Novartis

Danish Breast Cancer Cooperative Group

Professor, MD, PhD

Immediately after enrollment in the project, caregivers and patients receive the intervention

This group receives the same intervention as in the experimental group, but after the outcome assessment at 2 weeks

The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered

Identification and provision of lacking information

Mogens Groenvold, DMSc PhD MD

The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.

Improvement of Information to Cancer Patients' Caregivers

Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study

Investigated in focus group interviews with the health care professionals

Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)

Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"

Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"

Measures: CaTCoN subscale "Need for help from health care professionals"

Measure: The Hospital Anxiety and Depression Scale (HADS)

Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24

Herlev Hospital

Bispebjerg Hospital

Professor, DMSc, PhD, MD

Gland and Hormone Related Diseases

Nervous System Diseases

Recurrence

Thyroid Neoplasms

Thyroid Diseases

Paralysis

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery.

Patients randomized to this arm will undergo total thyroidectomy as per standard procedures with visual identification of the RLNs

The standardized technique of IONM-RLNs (bilaterally) will be used, including indirect vagal response evaluation at the beginning and also at the end of surgery according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group (INMSG) (Randolph GW, Dralle H. 2011).

IONM tube

Gouri Pantvaidya, MS,DNB,MRCS

Scientific objectives:

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Methodology:

All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation

Background and rationale of the study:

The incidence of the thyroid carcinoma has dramatically increased in the last few decades.1Total thyroidectomy with or without central compartment dissection is the treatment of choice for thyroid carcinoma. Vocal cord palsy (VCP) due to injury to the recurrent laryngeal nerve (RLN) is one of the most dreaded complications of this surgery. The symptoms associated with this complication include hoarseness of voice, voice fatigue and aspiration. Vocal cord palsy can be either temporary or permanent. The reported incidence of temporary VCP varies from 0-12%.2-4 However, the incidence of permanent VCP has been reported to be much lower varying from 0 to 3.5%.4,5Many patients may not present with symptoms of hoarseness and a post-operative laryngoscopic examination is required in all patients who have undergone surgery for thyroid cancer.6 However, the morbidity associated with VCP significantly affects the quality of life of the patient and at times require intervention to prevent aspiration or to improve voice quality.7 In a recent publication from our institute the invesigator found a temporary VCP rate of 11.8%.8

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery. There have been 4 RCTs and 2 meta analysis looking at the role of IONM in decreasing RLN palsy after thyroidectomy. The results from the same have been equivocal with 3 of 4 RCTs showing no added benefit in decreasing RLN palsy rates with the use of IONM.9-12 Of the 2 meta analysis, there was a decrease in RLN palsy rates in one of the meta analysis. 13 however the other Meta analysis by Higgins et al showed no improvement in RLN palsy rates with the use of IONM.14 In the meta analysis by Yang et al, published in 2016, there was a 44% (p=ns) decrease in temporary RLN palsy rates in the thyroid cancer cohort. However, the literature on use of IONM is still equivocal in literature. The other issue with available literature on use of IONM is that, most studies have looked at a heterogenous population of patients being operated for benign and malignant disease. Also most patients in the series evaluated have been patients who have undergone surgery for benign multinodular goiters. The extent of RLN dissection in these patients is limited as compared to patients undergoing surgery for thyroid cancers which involve total thyroidectomy and central compartment dissections. There have been no RCTs looking at the role of IONM in preventing RLN palsy in thyroid cancer surgeries. Also none of the RCTs performed have had a formal sample size calculation and robust analysis.

Section B: Aims and Objectives Aim: To assess the role of IONM in thyroid cancer surgery

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.

Phase III, Assessor Blinded, Randomised Controlled Trial of Use of Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery(ACTION)

The vocal cord mobility of each patient will be documented as mobile, fixed or restricted. Restriction of VC movement will be considered as an event for analysis. Other parameters like phonatory gap, arytenoid position, aspiration evaluation will also be done and recorded.

GRBAS score (Grade of Roughness, Breathiness, Asthenia and Strain)

Tata Memorial Hospital

Professor and Consultant Surgeon Department of Head & Neck Surgery, Tata Memorial Centre Secretary, Data Safety Monitoring Unit

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Prostatic Neoplasms

Lung Neoplasms

Weight Loss

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Gastrointestinal Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Dietary and antismoking advice, aiming to reduce participant's risk of cardiovascular diseases

Dietary advice with the aim of reducing participant's serum cholesterol levels, including reduction in the intake of saturated fat and cholesterol, and increased intake of polyunsaturated fat, fish, vegetables and fruit. Weight reduction was recommended for overweight men, as well as reduced consumption of sugar rich foods and drinks, and alcoholic beverages. Smokers were advised to stop smoking. The advice was given both individually and in group sessions during a five-year time period from 1972/3 until 1977/8.

Diet and antismoking advice

Paula Berstad, PhD

This study examines the effect of a five-year multifactorial lifestyle intervention in the Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high cardiovascular risk profile were randomised to intervention including cholesterol lowering diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of the intervention on 43-year cancer incidence and mortality.

The Oslo diet and antismoking study showed that a 5-year lifestyle intervention reduced the long-term risk of coronary events and mortality. The lifestyle risk factors for cancer are partly similar to those for coronary heart disease, e.g. smoking, high body weight, unfavourable diet. The investigators therefore expect that the intervention has an effect on cancer risk in the long term.

In this follow-up study, the investigators analyse the association between the intervention, and cancer incidence and mortality drawn from the Cancer Registry of Norway and the Norwegian Cause of Death Registry from the time of randomisation in 1972/3 until the end of 2015.

Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study

The Effect of Lifestyle Intervention on the Risk of Cancer - A Study of Participants in the Oslo Diet and Antismoking Study

Diagnosis of carcinoma in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Cancer Registry of Norway

Mortality in cancers in the oral cavity, oropharynx, esophagus, stomach, colorectum, liver and intrahepatic bile ducts, pancreas, larynx, trachea, bronchus and lung, urinary tract and thyroid gland, drawn from the Norwegian Cause of Death Registry

Any cancer diagnosis, drawn from the Cancer Registry of Norway

Mortality in any cancer, drawn from the Norwegian Cause of Death Registry

Diagnosis of carcinoma in gastro-intestinal tract, drawn from the Cancer Registry of Norway

Diagnosis of carcinoma in lung, drawn from the Cancer Registry of Norway

Diagnosis of carcinoma in urinary tract, drawn from the Cancer Registry of Norway

Diagnosis of carcinoma in prostate, drawn from the Cancer Registry of Norway

Oslo University Hospital

Principal Investigator

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Cyclophosphamide

Cetuximab

Prednisone

Rituximab

Vincristine

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Antineoplastic Agents, Hormonal

Involved field Radiotherapy (RT) 30-36 GY plus Cyclophosphamide, Vincristine and Prednisolone (CVP) + rituximab × 6 cycles

Involved field Radiotherapy (30-36 GY) alone

The prescribed dose to the target volume will be 30 Gy. Daily fractions of 1.5-2.0 Gy will be employed.

Radiotherapy

1.4 mg/m2 (maximum single dose of 2 mg) I.V. on day 1

Michael MacManus, MD

Patients with stage I and II low grade follicular lymphoma are randomised between standard therapy (involved field radiotherapy) and investigational therapy (involved field radiotherapy and chemotherapy plus rituximab). The main endpoint is progression free survival but overall survival and the influence of t(14;18) status will also be studied.

Radiotherapy is the only modality which has been proven to have curative potential in patients with localised low grade lymphoma. Despite excellent control of the local tumour, most patients relapse outside the area treated with radiation and most of these ultimately die from lymphoma. This study tests the hypothesis that the addition of six cycles of chemotherapy plus rituximab (systemic chemotherapy) can eradicate undetectable lymphoma deposits outside the radiation field and thereby improve the cure rate. The study will specifically test the hypothesis that six cycles of adjuvant CVP chemotherapy (cyclophosphamide, vincristine, prednisolone) in combination with Rituximab will improve progression-free survival for patients with stage I and II low-grade follicular lymphoma treated with involved-field radiotherapy (IFRT). That is, will patients given radiotherapy plus systemic chemotherapy live longer or remain free from disease longer than patients treated with radiation alone? Radiotherapy alone is widely regarded as the standard treatment for this disease.

There are a number of secondary endpoints to the study, as follows:

1. Comparison the pre- and post-treatment prevalence of the t(14:18) translocation, in peripheral blood and bone marrow, of patients treated with either IFRT alone or IFRT plus chemotherapy. This translocation is potentially a marker for minimal residual disease and eradication of the marker from blood cells may have prognostic implications. The clinical value of "molecular remission" as an early predictor of freedom from progression (FFP) and survival will be assessed.
2. Comparison of overall survival and FFP for patients treated with IFRT alone with overall survival and FFP for patients treated with combined IFRT and systemic therapy. Delay of progression of disease may be of limited value if overall survival is the same.
3. Comparison of acute and late toxicity and second malignancy rates for patients treated with IFRT or IFRT plus systemic therapy.
4. Delineation of the location of first relapse in relation to radiation therapy fields.

Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma

A Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy in Combination With Rituximab (Mabthera®) for Stage I - II Low Grade Follicular Lymphoma

Period from date of randomisation to date of death from any cause.

Period from date of randomisation to date of first relapse location via CT scan and or other imaging as required

Period from date of randomisation to date of higher histological grade via CT scan and or other imaging as required

Period from date of randomisation to date of first disease progression.

Australasian Leukaemia and Lymphoma Group

Trans Tasman Radiation Oncology Group

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Coagulants

Reproductive Control Agents

Kallikreins

Invitation to prostate cancer screening and questionnaires.

Registry-based follow-up and a questionnaire.

Depending on each diagnostic test result the participants in the screening arm will undergo PSA-testing, 4Kscore determination, MRI, and MRI/US fusion biopsy only.

Prostate cancer screening

Anssi Auvinen, MD, PhD

A population-based randomised trial of prostate cancer screening will be carried out. A total of approximately 117,200 men aged 50-63 in Helsinki and Tampere are randomised to intervention (screening) or control arm. A reduction in harms of screening in the form of overdiagnosis is sought, while retaining as much as possible of the mortality benefit (reduction in prostate cancer mortality). Novel methods that have been shown to increase specificity for clinically relevant prostate cancer but never tested in a randomised setting will be employed in screening and diagnostics. The main end-point is prostate cancer mortality at 10 and 15 years of follow-up.

Frequent adverse effects have so far tipped the balance of benefits and harms against prostate cancer screening, and therefore the investigators will focus on employing the best possible means for reducing them. The project introduces a novel concept for PC screening that minimises overdiagnosis and overtreatment, while retaining the mortality benefit to shift the balance of screening benefits and harms to a favourable net effect. The strategy for implementation as a randomised screening trial utilises three levels of risk assessment (PSA, kallikrein panel and MRI) before the diagnostic procedure (prostate biopsy), each aimed at eliminating detection of indolent disease. The study hypothesis is that by virtue of the novel three-tiered screening algorithm, the beneficial screening effect (prostate cancer mortality reduction) can be retained, while the overdiagnosis can be largely eliminated. The impact of an integrative approach has never been evaluated - each of the methods has only been assessed in isolation. The breakthrough potential of the proposal lies in combining the three novel approaches and taking them to the forefront of applied research through a randomised trial. The key impact of the study is in defining whether the overall balance of benefits and harms of prostate cancer screening can be reversed by applying the best possible methods to detect only clinically important disease. If the study hypothesis is affirmed, it opens the way to introduction of prostate cancer screening. If the balance of harms and benefits is still unfavourable, the problem of overdiagnosis in prostate cancer may be intractable.

Of the approximately 117,200 men aged 50-63 years resident in Helsinki and Tampere regions, a fourth will be randomised to screening and the rest to control arm (after exclusion of prevalent cases).

Trial participants will be identified by the Finnish Population Register Centre.

A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)

Prostate Cancer Screening Trial

The data will be managed and made openly available with Finnish Social Science Data Archive (FSD) and publisher websites. The type of data includes numerical data, mainly counts, and continuous variables classified as categorical. The data will be uploaded in tabular form (as a data matrix). The data will be deidentified and supplied only as frequencies. The released data will be available under CC license for research purposes (accessible for registered users of FSD database). Citation of the original research is needed whenever used by third parties.

Diagnostic performance of 4Kscore among men with PSA\>3 in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).

Diagnostic performance of MRI based on PI-RADS v2 scores among men with PSA\>3 and positive 4Kscore in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).

Health-related quality of life among men diagnosed with prostate cancer will be assessed using the EPIC 26 instrument enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.

Anxiety among men diagnosed with prostate cancer will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.

Adverse effects of biopsy are evaluated using a questionnaire on complications including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment immediately after the biopsy.

Adverse effects of biopsy are evaluated with a questionnaire on complications, including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment 30 days after the biopsy.

Economic evaluation will commence with cost analysis, and the final analysis of incremental cost effectiveness ratio (with a decision analysis) will be conducted once data on both long-term cost and real outcome data on both utilities (quality-adjusted life-years) and mortality are available.

An intention to screen analysis will be performed, with all men in the groups defined by random allocation, regardless of compliance. Follow-up starts at randomisation, and ends at death. Cox regression will be used with prostate cancer death as the outcome.

A secondary analysis of prostate cancer mortality will be performed using the Cuzick method with correction for contamination and selection bias due to non-compliance.

Intermediate outcomes include cumulative incidence of advanced (T3-T4 or M1) prostate cancer (number of cases relative to population size, not using incidence density to avoid the lead-time bias due to early detection by screening).

Intermediate outcomes include cumulative incidence of low-risk cancer (Gleason\<7) as an indicator of overdiagnosis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer	NCT00908531	Operable Breast...	letrozole (Fema...	60 Years -	Danish Breast Cancer Cooperative Group
Improvement of Information to Cancer Patients' Caregivers	NCT02380469	Neoplasms	Identification ...	18 Years -	Bispebjerg Hospital
Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.	NCT04842994	Malignant Neopl...	IONM tube	-	Tata Memorial Hospital
Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study	NCT03410641	Cancer Gastrointestina... Lung Cancer Urinary Tract C... Prostate Cancer	Diet and antism...	40 Years - 49 Years	Oslo University Hospital
Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma	NCT00115700	Follicular Lymp...	Cyclophosphamid... Radiotherapy Vincristine Prednisolone Rituximab	18 Years -	Trans Tasman Radiation Oncology Group
Improvement of Information to Cancer Patients' Caregivers	NCT02380469	Neoplasms	Identification ...	18 Years -	Bispebjerg Hospital
A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)	NCT03423303	Prostate Cancer	Prostate cancer...	50 Years - 63 Years	Tampere University

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