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Neoplasms, Second Primary clinical trials

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NCT ID: NCT06204510 Recruiting - Lymphedema of Leg Clinical Trials

Effects of Complex Decongestive Therapy on Proprioception, Balance and Tactile Sense

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effects of complex decongestive physiotherapy (CDP) on propriseception, balance and sensation in patients with secondary lymphedema that develops in the lower extremities after cancer surgery.

NCT ID: NCT06200831 Recruiting - Colorectal Cancer Clinical Trials

Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases

SYLMET
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

NCT ID: NCT06185556 Not yet recruiting - Colorectal Cancer Clinical Trials

COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases

COLDFIRE-III
Start date: March 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.

NCT ID: NCT06165419 Recruiting - Clinical trials for Metastatic Breast Cancer

Definitive Radiation for High-Risk Spine Metastases

Start date: December 14, 2023
Phase: Phase 2
Study type: Interventional

This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery

NCT ID: NCT06137651 Withdrawn - Breast Carcinoma Clinical Trials

Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis

Start date: December 31, 2023
Phase: Phase 1
Study type: Interventional

This phase I/Ib trial tests the safety, side effects, and best dose of vinorelbine when given in combination with trotabresib in treating patients with HER2 positive breast cancer that has spread to the central nervous system or leptomeninges (metastasis). Cancer cells that make too much HER2 may grow more quickly and are more likely to spread to other parts of the body as metastases, including the central nervous system. Trotabresib is part of a family of drugs called BET inhibitors. Trotabresib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vinorelbine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body. Giving trotabresib and vinorelbine may increase in the anti-cancer activity of vinorelbine when used in combination with radiation (radiotherapy).

NCT ID: NCT06101849 Recruiting - Breast Cancer Clinical Trials

Chronic Cancer Pain Management Program

ICMP
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this research study is to evaluate an online inter-professional pain management program for survivors of breast cancer. The main questions it aims to answer: 1. whether this treatment will help address the pain management concerns of patients, 2. whether it is feasible to offer this treatment in the future as multi-centre randomized controlled trial (RCT). Participants will be asked to attend a 6-week online pain management group sessions (1h/week). Participants will also be asked to fill out questionnaires before and after the program completion.

NCT ID: NCT06085716 Recruiting - Fatigue Clinical Trials

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Start date: February 16, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

NCT ID: NCT06084780 Not yet recruiting - Clinical trials for Pseudomyxoma Peritonei

Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)

TRANSCAPE
Start date: April 2024
Phase: Phase 2
Study type: Interventional

The goal of this prospective phase 2 study is to assess the efficacy and safety of intestinal or multivisceral transplantation for participants with PMP not amenable to other curative-intent treatments. Participants will undergo intestinal/multivisceral transplantation. Participants will be followed for 12 months to assess efficacy and safety.

NCT ID: NCT06050200 Not yet recruiting - Liver Cancer Clinical Trials

TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery

TANGO-LIVER
Start date: November 2023
Phase: N/A
Study type: Interventional

Liver resection is the treatment of choice in patients with malignant liver lesions. Unfortunately, the surgery is not always an option, as in same patients the future remnant liver (FRL) is too small to supply all the functions. Therefore, some additional methods have been proposed to increase the size of the FRL. The aim of this study is to compare the efficacy and safety of three methods of increasing the future remnant liver - Portal Vein Embolization (PVE) - embolization of one of the portal branches; Liver Vein Deprivation (LVD) - embolization both of the portal branch as well as the hepatic vein; and partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection. The efficacy of those three methods will be assessed both by analyzing the volumetric increase (by computer tomography scans) and by functional increase (by 99mTc-mebrofenin scintigraphy). Functional assessment of the liver hypertrophy seems to be of crucial importance, as some of the previous studies suggest that there might be a significant discrepancy in the increase of size comparing to the increase of function. This is a prospective, interventional randomized study. The study group (154 patients) will consist of patients being considered as candidates for major hepatic resection, after inducing hypertrophy of the future remnant liver. The primary study hypothesis is greater efficacy of ALPPS in preparing patients for large hepatic resection by inducing hypertrophy of the future remnant liver, as compared both to PVE and LVD. In case of unsuccessful induction of hypertrophy by the embolization techniques, patients may be qualified to rescue ALPPS procedure. Primary end-point: Percentage of patients with successful resection (patients, who gained sufficient increase of the FRL to proceed to the liver resection) with no post-surgical 90-day mortality. Secondary end-points: 1. the rate and degree of volume increase in different groups 2. the rate and degree of functional increase in different groups 3. CCI index and complication rate >=3 degree according to the Clavien-Dindo classification after the first stage of treatment 4. CCI index and complication rate >=3 degree according to the Clavien-Dindo classification after the second stage of treatment 5. overall duration of hospital stay Patient will be randomly assigned to the three study groups. All patients will undergo an abdominal contrast enhanced computed tomography and 99mTc-mebrofenin scintigraphy prior to the first stage of treatment. During the first stage of treatment, patients will undergo, according to their group: 1. Embolization of portal vein branch (PVE, portal vein embolization) 2. Embolization of both portal vein branch and hepatic vein (LVD, liver venous deprivation) 3. Partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection, preferentially by laparoscopic technique Computed tomography scans and scintigraphy will be repeated at day 7, 14 and 21 after the first stage of treatment. The second stage of treatment, the liver resection, will be performed after achievement of sufficient mebrofenin clearance rate (>=2,69%/min/m2). In case of failure to reach the desired clearance rate, the measurements will be continued every 7 days up to day 42. In case of uncertainty and discrepancy between the volumetric assessment in the computed tomography scan and the mebrofenin scintigraphy, it will be allowed to proceed to stage two (partial hepatectomy) after joint consultation of at least 3 hepatobiliary surgeons, 1 radiologist and 1 nuclear medicine specialist. Routine blood tests will be performed according to the standard procedure in the Department, depending on the patient clinical status. An additional blood sample will be collected from patients (after receiving and additional informed consent from the patient) and will be stored in the biobank. All patients will be monitored for surgical and 90-day complications. The volume increase after first stage of treatment, the functional increase after first stage of treatment, percentage of patients successfully proceeding to the second stage of treatment and complication rate will be calculated. The percentage of patients with complications >= 3 degree in Clavien-Dindo classification and CCI index for each patient will be calculated. Furthermore, the blood test results will be assessed to search for associations with patients' outcomes. Any possible differences in terms of baseline patients characteristics between groups will be addressed. Statistical analysis will be performed using U Mann-Whitney test, exact Fisher's test, logistic regression, general linear models, Kaplan-Meier method and log-rank test. All three groups will be assessed in terms of occurrence of primary and secondary end-points.

NCT ID: NCT06048094 Recruiting - Brain Metastases Clinical Trials

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

FACILITATE
Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.