Clinical Research Directory

Medical Payment Case Management for Financial Toxicity in Patients With Primary Bone Tumors: A Randomized Controlled Trial

The goal of this clinical trial is to learn if adding a medical payment case management service to the hospital's usual follow-up care can reduce the financial hardship of cancer treatment in patients of any age, including children and teenagers, who have a primary bone tumor and are scheduled to have surgery at Shanghai Sixth People's Hospital. It will also learn whether the service lowers the number of families who spend a large share of their yearly income on medical care. The main questions it aims to answer are: Does the service improve patients' scores on a questionnaire that measures financial hardship (the COST-FACIT) from the start of the study to 6 months later? Does the service lower the number of families whose out-of-pocket medical costs reach 10% or more of the family's yearly income? The study will enroll 124 patients, randomly assigned in a 1:1 ratio to two groups of 62: Payment service group: patients receive the hospital's usual follow-up care, plus help from a dedicated payment specialist (called a Co-Pay Navigator). Control group: patients receive the hospital's usual follow-up care only. They can still ask the hospital about payment questions at any time. Researchers will compare the two groups to see if the payment service reduces financial hardship. Both groups receive the whole-course patient management program of the hospital's Comprehensive Oncology Center (COC), which includes: Reminders to return for scheduled check-ups, with alerts if a check-up is missed A record of their medications, with reminders to take them as prescribed Questionnaires they fill in through the program, which the system checks for warning signs that a case manager then follows up Patient education materials about the disease and about follow-up care Online access to a case manager for questions at any time All participants will also: Answer short questionnaires about their family's medical costs at the start of the study and again about 3, 6, 9, and 12 months later, on a mobile phone and with help from the study staff if needed Have a parent or other family member who helps care for them answer a short questionnaire about the strain of caregiving Participants in the payment service group will also work with a Co-Pay Navigator, who: Reviews the family's insurance coverage and out-of-pocket costs Explains which payment programs the family may be able to use: basic medical insurance, critical illness insurance, supplemental medical insurance, charity programs, drug company assistance programs, social assistance, and fundraising Helps the family apply for these programs and follows the applications Reviews the hospital bill when the patient leaves the hospital Checks in every three months to update the family's payment plan Taking part does not involve extra clinic visits, blood tests, or study drugs, and the study does not change any medical treatment.

Phase I/II Trial of Dinutuximab Beta in Combination With Irinotecan and Rapamycin in Pediatric, Adolescents and Adult Patients With Relapsed/Refractory Bone Tumors.

Osteosarcomas, like other primitive bone tumors, remain hard-to-treat malignancies, especially after failure of first-line treatments. Multiple mechanisms are initiating or rendering bone tumor cells resistant to the chemotherapies leading to the drastic reduction of treatment possibilities in case of relapses. Among the list of extra-tumoral mechanisms enabling this cancer cell resistance, hypoxia and tumor-associated macrophage modulation seem to be in the top ranks. Based on that, we generated by the past tumor data where the study of hypoxic biomarkers' expressions and the presence of protumoral macrophages were influencing the prognosis of osteosarcoma patients. In fact, the association of HIF1 hyperexpression and a high number of M2 phenotype macrophages (e.g., protumoral cells) were predictive markers of the worst outcome. We recently redone this translational approach in other bone tumors like Ewing sarcomas (EWS) showing the same prognostic tendency. Furthermore, a past pediatric phase I trial, named RAPIRI, targeting both mTor and HIF1, with combination of Sirolimus and Irinotecan, was able to provide in the relapsing bone cancers a partial response or stable disease in more than 50% of patients and particularly in patients with blood concentrations of Sirolimus between 5 and 15 µg/L. To go further and understand the potential links between macrophages and hypoxic resistant tumors, recent preliminary exploration, with an immunofluorescent assessment targeting GD2 expression on tumor cell membranes, was underlining osteosarcomas but also EWS with standard fusions and CIC-DUX4 cancers as hyperexpressing cancers for this disialoganglioside. The cell-surface molecule was highly expressed in 22 out of 32 diagnostic samples (unpublished data). This glycosphingolipid usually presenting a restricted pattern of expression on normal tissues seems to be frequently hyperexpressed in some cancers and therefore amenable to targeting by the monoclonal antibody Dinutuximab beta. The anti-GD2 effect of this drug relies on complement and immune effector cells to mediate cancer cell killing. Recent and unpublished preclinical data in our Lab (UMR-CNRS7021, Strasbourg) envisioned the proof-of-concept combining Sirolimus, Irinotecan and Dinutuximab beta in osteosarcoma models and afford sustainable results to conclude to a clear efficiency of this triple combination stopping completely osteosarcoma cell proliferation and reducing drastically their invasion in microenvironment. Gathering all those prerequisite data and, as the monoclonal therapeutic antibody (Dinutuximab beta) now is extensively evaluated in clinics in multiple indications (e.g., neuroblastomas, Ewing sarcomas and other sarcomas), we propose here a phase I/II trial with this combination of treatments targeting hypoxia and GD2 in bone tumors focusing on relapsing bone tumors with endpoints determining accurate dose to give to patients and its efficacy at 16 weeks of treatment.

A Dose Finding Study to Treat Bone Tumor(s)

To determine the Maximum Tolerated Dose (MTD) of CycloSam®, Samarium-153-DOTMP (Sm-153-DOTMP), a radiopharmaceutical that delivers radiation to the bone when injected, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan.

Proximal Femur Reconstruction Following Resection of Primary Bone Tumors: Analysis of the Clinical and Radiographic Results

From the archives of the Rizzoli institute all the patients (approximately 150 patients) undergoing oncological reconstruction of proximal femur from 01/01/1991 to 31/12/2023. A review will be made from the medical records, radiological imaging, and histological data of these patients

Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)

This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations. Eligible patients must have disease progression after standard therapy or no suitable standard treatment options. Participants will receive either crizotinib (Xalkori®) or alectinib (Alecensa®), with treatment selection determined by the study investigators. The study aims to assess antitumor activity, safety, and clinical outcomes in this rare molecular subtype of bone cancer.

Functional Outcomes of Knee Protheses for Malignant Tumours of Bone

The placement of mega knee prosthesis is a necessity after a large tumor resection and oncological. These mega knee prostheses implanted in the context of oncological surgery have been very few evaluated in the literature. Active knee extension is essential in order to walk properly. The study propose the evaluation of this prosthesis by checking the possibility of locking of the prosthetic joint and thus the possibility of active walking. A more in-depth, isokinetic analysis at 1 year of follow-up will also be done in an exploratory manner, as the literature has no data on this subject.

9-ING-41 in Patients With Advanced Cancers

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.

Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions

Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system that are often inherited and genetically heterogeneous. Genetic screening is recommended for patients and their relatives, and can guide clinical decisions. However, a mutation is not found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with pheochromocytoma/paraganglioma of various genetic origins.

Evaluating Stereotactic Body Radiation Therapy for Oligometastatic Disease of the Bone

This research study is studying a form of radiation therapy called stereotactic body radiation therapy or SBRT as a possible treatment for Cancer that has spread to the spine or other bone

Pediatric Oncological Orthopaedic Reconstruction

From the archives of the Rizzoli institute all the children undergoing oncological reconstruction from 1991 to 2023 (approximately 400 patients). A review will be made of the medical records, radiological imaging, and histological data of these patients

Osteosarcoma Maintenance Therapy With OST31-164

Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.

Insights Into Participating in Studies for Bone Cancer

Clinical studies, with a distinct focus on bone cancer, play a crucial role in evaluating the safety and effectiveness of novel treatments for this disease. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.