Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Rare Diseases

Kidney Diseases

Carcinoma

Carcinoma, Renal Cell

Cysts

Kidney Neoplasms

Kidney Diseases, Cystic

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Neoplasms

Urogenital Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients undergo excision of a renal mass by partial or radical nephrectomy and will be followed by UISS risk classification.

Patients enter active surveillance protocol. Delayed surgery on active surveillance will be recommended if progression from Bosniak 3 to 4 or a solid mass is noted on imaging by radiologist

Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.

Delayed surgery

Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass

Immediate surgery

Harry Nisén, Adj. professor

Juhana Rautiola

Harry Nisén

The incidence of renal cysts is rising due to increased abdominal imaging. Renal complicated cysts have been traditionally classified according to the Bosniak classification, which distinguishes cystic masses by specific features of walls and septa. The categories I and II are benign and class IIF most probably benign but needs a short radiological follow-up. Categories III and IV have been traditionally operated due to the increased risk of renal cell carcinoma. However, recently published studies show that approximately 50% of the operated Bosniak III cystic masses are benign, which means that half of the cases are overtreated by surgery. It has also been shown that surgical pathology of stable Bosniak IIF cysts is malignant in less than 1%, while the cysts, which are upgraded to higher Bosniak classes will show malignant surgical pathology in 85%. So far, there is lack of prospective data on active surveillance in Bosniak III cystic masses.

The aim of the study is to compare active surveillance and surgery in patients with Bosniak III renal cystic masses. Patients will be randomized in active surveillance or immediate surgical excision of a cystic mass. In the active surveillance group, patients are followed according to the study protocol for 10 years and treated with delayed surgery if the cystic mass upgrades into Bosniak IV/solid, becomes symptomatic or grows over a preclassified threshold. The primary objective is to compare surgical pathology between patients treated with immediate surgery versus delayed surgery.

According to recent retrospective data, active surveillance of Bosniak III cystic masses is reasonable and oncologically safe. Therefore a prospective randomized controlled trial is needed to get high level evidence to support a change in the treatment strategy. The study may significantly reduce unnecessary operations performed in patients with Bosniak III cystic masses.

Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts

A Prospective Multicenter Trial Comparing Surgery Versus Active Surveillance In Patients With Bosniak 3 Renal Cystic Masses, A NoRenCa And FinnKidney Study

All IPD that underlie results in a publication.

Helsinki University Central Hospital

Adjunct professor

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Cancer, Papillary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Adenocarcinoma

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

Group with active surveillance of their Papillary Thyroid Cancer

Group who underwent surgery after diagnosis Papillary Thyroid Cancer

Eun Kyung Lee

Jae Hoon Moon

Young Joo Park

Ka Hi Lee

This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer.

Active Surveillance for Low-risk Papillary Thyroid Carcinoma

Study Protocol of Extended Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Carcinoma (MAeSTroⅡ)

Disease progression in the following criteria: (1) a size increase of ≥3 mm in maximum diameter; (2) a cytopathological diagnosis of a new thyroid cancer lesion; (3) a cytopathological diagnosis of a cervical LN metastasis; or (4) clinical or radiological suspicion of a distant metastasis.

Defined as follows: primary tumor growth \>13 mm in largest diameter or primary tumor 20mm in largest diameter in the active surveillance group, or new metastatic disease or newly diagnosed thyroid cancer in the active surveillance group and surgical group

The rate of participants in the active surveillance group who cross over to thyroidectomy without disease progression during follow-up will be reported.

The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale.

Hospital Anxiety and Depression Scale is a measure developed to measure anxiety and depression symptoms in general hospital visiting patients. it is consists of a total of 14 questions, 7 questions related to anxiety and 7 questions related to depression, and the higher the score, the higher the level of anxiety and depression.

minimum score 0, maximum score 40, where a lower number indicates a worse outcome

Participants will be asked the reason for choosing Active surveillance or surgery decision is complete for the disease management plan. Each participant will be asked, in a semi-structured interview question, to explain the reason why the disease management strategy that was chosen.

Seoul National University Bundang Hospital

SMG-SNU Boramae Medical Center

Seoul National University Hospital

National Cancer Center, Korea

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).

immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).

once daily afatinib at a dose of 40 mg for 8 weeks

anatomical resection and systematic lymph node dissection

Sanjay Popat, PhD

This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.

After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:

* Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
* Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).

Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.

The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.

Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group

decrease in cT-stage descriptor measured according to RECIST 1.1

proportion of patients whose response is either complete response (CR) or partial response (PR) using RECIST 1.1;

European Organisation for Research and Treatment of Cancer - EORTC

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Docetaxel

Fluorouracil

Cisplatin

Tubulin Modulators

Antimitotic Agents

Surgery followed by Taxotere-Cisplatin-5FU

Taxotere-Cisplatin-5FU

Immediate surgery followed by Taxotere-Cisplatin-5FU

Rudolf Morant, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.

PURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.

OBJECTIVES:

* Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.
* Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).

* Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.
* Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.

Quality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.

Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer

A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Surgery and Active Surveillance in the Treatment of Bosniak III Renal Cysts	NCT04670887	Cystic Renal Di... Kidney Cancer Surgery	Delayed surgery Immediate surge...	50 Years - 75 Years	Helsinki University Central Hospital
Active Surveillance for Low-risk Papillary Thyroid Carcinoma	NCT06261190	Thyroid Cancer Papillary Thyro...		18 Years -	National Cancer Center, Korea
Active Surveillance for Low-risk Papillary Thyroid Carcinoma	NCT06261190	Thyroid Cancer Papillary Thyro...		18 Years -	National Cancer Center, Korea
Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.	NCT02470065	Non Small Cell ...	Afatinib Immediate surge...	18 Years - 90 Years	European Organisation for Research and Treatment of Cancer - EORTC
Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer	NCT00005060	Gastric Cancer	Taxotere-Cispla... Immediate surge...	18 Years - 75 Years	Swiss Group for Clinical Cancer Research

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