Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Sarcoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Soft Tissue Sarcoma

Subjects who are with gastrointestinal malignancies or sarcoma receive radiotherapy.

Patient Reported Outcome (PRO) questionnaire

Survey

Toxicity Assessments will be performed using the National Cancer Institute Common Terminology Criteria (NCI-CTCAE).

Toxicity Assessments

Victoria Xu, MD, PhD

Olivia Roberts

Victoria Xu

Theodore K Yanagihara, MD

Theodore K Yanagihara

This prospective, single-institution, observational study explores disease outcomes and toxicities in subjects with gastrointestinal malignancies and sarcoma (bone and soft tissue) who are being treated with standard-of-care therapies including radiotherapy.

Recent advances in treatment approaches affected disease outcomes and toxicities. Prospective monitoring of disease outcomes and toxicities using standardized assessments will provide information about recent changes in the standard of care and further refine treatment approaches and prospective clinical trial design.

Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies

Disease-free survival is defined as the length of time after treatment in which the subject survives with no signs or symptoms of cancer.

Local Control is defined as radiographic and clinical assessments determined by the patient's treating physician.

The NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5 is a descriptive terminology that can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Quality of life PRO-CTCAE will be evaluated using patient-reported quality of life The PRO-CTCAE is a measurement system that characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities that include pain, fatigue, nausea, and cutaneous side effects such as rash and hand-foot syndrome, all toxicities that can be meaningfully reported from the patient's perspective.

PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present).

Quality of life EQ-5D-5L will be evaluated using EQ-5D-5L. The EQ-5D-5L is a QoL assessment that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels ranging from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5) to extreme problems.

Toronto Extremity Salvage Score (TESS) quality of life questionnaire will be used in subjects with sarcoma.

The TESS is a 30-item patient-reported outcome questionnaire that addresses daily activity limitations including restrictions in body movement, mobility, self-care, and performance of daily tasks. It is scored from 0 (not possible) to 5 (without any problem). Higher scores indicate less functional limitation.

UNC Lineberger Comprehensive Cancer Center

Blood and Lymph Conditions

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Venetoclax

Azacitidine

Antimetabolites

Enzyme Inhibitors

4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2

Pharmacokinetic sampling

Survival situation 12 months after start of treament

Vital status determination

Toxicity assessments

Venetoclax and azacitidine combination

Thomas Cluzeau, Pr

Valérie FOUSSAT

Geoffroy Venton, MD

Thomas Cluzeau

The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.

Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE

Correlation of VEN plasma levels with inhibition of its Bcl-2 target

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Disease Outcomes and Toxicities in Patients With Gastrointestinal and Sarcomatous Malignancies	NCT05743426	Sarcoma Gastrointestina...	Survey Toxicity Assess...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven	NCT06030089	Acute Myeloid L...	Pharmacokinetic... Vital status de... Toxicity assess... Venetoclax and ...	18 Years -	Centre Hospitalier Universitaire de Nice
Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven	NCT06030089	Acute Myeloid L...	Pharmacokinetic... Vital status de... Toxicity assess... Venetoclax and ...	18 Years -	Centre Hospitalier Universitaire de Nice

Spots Global Cancer Trial Database for toxicity assessments