Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The Trans-Atlantic Prostate Group (TAPG) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.

In 1999, the TAPG group initiated the "Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting" study, referred to as the TAPG study. It is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. Initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (TURP) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. Data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the TAPG Central Coordinating Office (CCO). Selection of eligible patients for the study completed in 2010. Since this year the TAPG CCO has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.

Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting

Time from date of inclusion until death from prostate cancer.

Time from date of inclusion until death from any cause.

Correlation of serum PSA level taken within 6 months of date of inclusion compared to death from prostate cancer.

Correlation of Gleason Score at date of inclusion compared to death from prostate cancer.

Stratification of clinical stage at date of inclusion compared to death from prostate cancer.

Correlation of ki-67-positive cells compared to prostate cancer-specific survival.

Correlation of ki-67-positive cells compared to overall cancer-specific survival.

Correlation of ERG-ETV1 rearrangement status compared to prostate cancer-specific survival.

Queen Mary University of London

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Melanoma

Death

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Nivolumab

Trametinib

Dabrafenib

Participants who started adjuvant nivolumab

Participants who started adjuvant pembrolizumab

Participants who started adjuvant dabrafenib + trametinib combination therapy

Participants with no systemic treatment during the study observation period until record of recurrence

Bristol-Myers Squibb

The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.

A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy

Treatment Patterns and Outcomes for Patients With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy in the US Community Oncology Setting

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Marit van der Sande, MD

Niels Koomen, MD, PhD

Geerard Beets, MD, PhD

Regina Beets-Tan, MD, PhD

Monique Maas, MD, PhD

Doenja Lambregts, MD, PhD

Jurriaan Tuynman, MD, PhD

Rogier Crolla, MD, PhD

Koen Talsma, MD, PhD

Erik Sonneveld, MD, PhD

Christiaan Hoff, MD, PhD

Koen Peeters, MD, PhD

Stephanie Breukink, MD, PhD

Hans de Wilt, MD, PhD

David Zimmerman, MD, PhD

Apollo Pronk, MD, PhD

Martijn Intven, MD, PhD

Erik van Westreenen, MD, PhD

Regina Beets -Tan, MD, PhD

The aim of this prospective observational cohort study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation for rectal cancer.

Standard treatment for patients with locally advanced rectal cancer consists of a long course of (CRT) followed by surgical resection. Although the aim of neoadjuvant treatment in these patients is not organ preservation, but rather to provide improved local control, in the tumour disappears completely. Studies from Maastricht, the UK and Brazil have shown that in selected patients with a clinical complete response after CRT, a "wait-and-see" policy without any surgery could be a safe alternative with comparable long-term outcome and better functional outcome compared to patients who had surgery.

The main objective of the study is to provide short and long term oncological and functional outcome data on organ preserving treatment in good responders after a standard indication for neoadjuvant (chemo)radiation. Additional aims are: to set up a national network with expertise centres in the 'wait-and-see' treatment of rectal cancer; to set up a national registry for organ preservation treatment that will generate more evidence on the management and oncological outcome of patients evaluated and treated with organ preservation and \[3\] to offer through this network to all patients who are considered good candidates this 'wait-and-see' approach using the most up to date tools for selection and follow-up.

Study design: multicenter prospective observational cohort study and implementation study. Study population: The population will consist of patients, aged 18 years or older, with rectal cancer who after a long course of CRT or a short course of radiation with a long waiting interval have a clinical complete response (ycT0N0).

The main study endpoint is 2-year non-regrowth disease-free survival. Secondary endpoints are \[1\] the number of fully operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands, \[2\] 2-year regrowth rate, \[3\] 2-year local control, \[4\] 2-year overall survival, \[5\] determination of the optimal follow-up schedule and \[6\] quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the majority of patients who participate in the study, major surgery and the associated morbidity can be avoided. Although scientific proof shows "wait-and-see" only comes with a small risk with adequate selection and follow up, the exact risk is not yet well established and needs to be confirmed by this study. The benefit-risk ratio for this study is regarded as favourable.

"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer

Multicentre Evaluation of the "Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer

Absence of non-regrowth local or distant recurrence or death within 2 years of follow-up

Number of operational centres who can deliver high quality organ preserving care in rectal cancer in the Netherlands

Absence of local recurrence(unresectable regrowth, resected with R1, or requiring more extensive than TME surgery) or death

A balance between early detection of recurrence and compliance to follow-up

Quality of life (general health, disease specific and functional outcomes)

Dutch Cancer Society

The Netherlands Cancer Institute

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Hodgkin Disease

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Cyclophosphamide

Prednisone

Prednisolone

Methylprednisolone

Vinblastine

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL

3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)

cyclophosphamide

prednisolone

vinblastine sulfate

watchful waiting

therapeutic conventional surgery

Dieter Koerholz, MD

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Surgery to remove involved lymph nodes may be an effective treatment for young patients with nodular lymphocyte-predominant Hodgkin lymphoma.

PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.

OBJECTIVES:

Primary

* Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone.

Secondary

* Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients.

OUTLINE:

* Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment.
* Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol.

After completion of study treatment, patients are followed-up periodically.

Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents

Time from treatment start until relapse/progression, secondary malignancy or death

Stage greater than IIA at relapse diagnosis

Evaluation of AEs, SAEs atc. according to CTC

Deutsche Krebshilfe e.V., Bonn (Germany)

Euronet Worldwide

Christine Mauz-Körholz

Prof. Dr. Christine Mauz-Körholz

Behaviors and Mental Disorders

Quality of Life

The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).

1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
2. Short Form (36) health survey
3. EORTC CR38
4. Vaizey score
5. Low Anterior Resection Syndrome (LARS) score
6. International Index of Erectile Function for men
7. International Prostate Symptom Score for men
8. Female Sexual Function Index for women

Questionnaires for the evaluation of Quality of Life

Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).

Manometry

Geerard L Beets, MD, PhD

Rianne CJ Beckers, MD, MSc

Miriam M van Heeswijk, MD, MSc

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

Rectal cancer is a common form of cancer. Standard treatment for locally advanced rectal cancer is a long course of neoadjuvant radiation combined with chemotherapy (CRT) followed by resection. However, neoadjuvant CRT induces downsizing and downstaging, resulting in a complete response in 15-20% of the patients. In these patients surgery may be omitted. In the investigators previous study the investigators obtained good results with an organ saving treatment. Although the mortality and morbidity associated with radical surgery is avoided, the irradiated rectum remains in situ, possibly causing functional problems.

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment. Functional outcome will be evaluated with questionnaires (quality of life) and manometric measurements (maximal resting pressure, maximal squeezing pressure, sphincter length, percentage asymmetry of the resting sphincter, sustained duration, length of the high pressure zone, rectoanal inhibitory reflex, rectal sensory threshold, and rectal compliance).

Secondary objectives include: the estimation of the cumulative risk of local failure within 5 years, the estimation of the cumulative risk of disease-free, distant-metastasis-free and overall survival within 5 years, determine the percentage of patients that chooses organ saving treatment instead of standard resection, determine the compliance to intensive follow-up, and compare the cost-effectiveness of organ saving treatment to standard surgical resection over a period of 5 years. These objectives will be assessed by frequent revision of the electronic patient file, as the patient is followed up to four times per year.

Study design: prospective observational registration study with 'invasive diagnostic procedures' Study population: The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).

Main study parameters/endpoints: The main study endpoint is the functional outcome scores based on questionnaires and manometric measurements Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The questionnaires take approximately 20 minutes to complete. There is a relatively low rate of side effects associated with manometric measurements. Results of this study will contribute to better understanding of functional complaints after rectal cancer treatment.

Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer

Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer

Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature.

Functional outcome will be evaluated with the following questionnaires:

1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
2. Short Form (36) health survey
3. EORTC CR38
4. Vaizey score
5. Low Anterior Resection Syndrome (LARS) score
6. International Index of Erectile Function for men
7. International Prostate Symptom Score for men
8. Female Sexual Function Index for women

Functional outcome will be measured by manometric measurements:

1. mean basal pressure (mmH2O)
2. maximum squeeze pressure (mmH2O)
3. first sensation (mL)
4. first urge to defecate (mL)
5. maximum tolerable volume (mL)

All patients with a local recurrence will be excluded form further follow-up. This information will be based on an MRI of the lower abdomen in combination with endoscopy.

All patients are intended to participate in the standard follow-up schedule. Some of them may drop out due to other illness, ageing or other reasons. These patients will be included in the analysis as far as they participated.

In the first year, every three months an MRI of the lower abdomen is made in combination with an endoscopy. From the second to the fifth year, these investigations will be done twice a year. With these short intervals, it is know that local recurence is detected in an early fase.

Maastricht University Medical Center

Anders Jakobsen, DMSc

The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma.

Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response.

Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated.

Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.

Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Vejle Hospital

Recurrence

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Renal Cell Carcinoma

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Patients with any renal tumor diagnosed with conventional imaging (computed tomography or magnetic resonance imaging) and undergoing to a clinical management in a hugh-volume center.

Conservative removal of kidney tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.

Partial Nephrectomy (PN)

Surgical removal of the affected kidney. Adrenal removal can be performed according to surgeon choice and clinical characteristics of the renal tumor. The procedure can be performed either with an open or laparoscopic or robotic approach.

Radical Nephrectomy (RN)

The procedure of tumor ablation performed with radiofrequency or cryoablation. The procedure can be performed either with a laparoscopic approach or percutaneous access.

Ablation therapy (AT)

Active surveillance is defined as the initial management including the monitoring of renal tumor size by serial imaging with delayed treatment in case of progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting	NCT03912883	Prostate Cancer		18 Years - 76 Years	Queen Mary University of London
Prognostic Factors in Prostate Cancer for Patients Treated by Watchful Waiting	NCT03912883	Prostate Cancer		18 Years - 76 Years	Queen Mary University of London
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy	NCT05432622	Melanoma		18 Years -	Bristol-Myers Squibb
"Wait-and-see" Policy for Complete Responders After Chemoradiotherapy for Rectal Cancer	NCT03426397	Rectal Neoplasm...		18 Years -	The Netherlands Cancer Institute
Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma	NCT01088750	Lymphoma	cyclophosphamid... prednisolone vinblastine sul... watchful waitin... therapeutic con...	- 17 Years	Martin-Luther-Universität Halle-Wittenberg
Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer	NCT02278653	Rectal Neoplasm...	Questionnaires ... Manometry	18 Years -	Maastricht University Medical Center
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy	NCT00952926	Rectal Cancer		18 Years -	Vejle Hospital
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors	NCT05363657	Kidney Cancer	Partial Nephrec... Radical Nephrec... Ablation therap... Active Surveill...	18 Years -	Azienda Ospedaliero-Universitaria Careggi
A Study of Treatment Patterns and Outcomes in Participants With Stage IIIA Melanoma Receiving Adjuvant Systemic Therapy	NCT05432622	Melanoma		18 Years -	Bristol-Myers Squibb
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors	NCT05363657	Kidney Cancer	Partial Nephrec... Radical Nephrec... Ablation therap... Active Surveill...	18 Years -	Azienda Ospedaliero-Universitaria Careggi

Spots Global Cancer Trial Database for watchful waiting