Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Sarcoma

Retroperitoneal Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Abdominal Neoplasms

Quality of Life

Soft Tissue Sarcoma

No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma (RSTS).

In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study.

The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term.

Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0.

Secondary objectives

* Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure.
* Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI questionnaires.
* Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI.
* Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual interest, Impotence, Dyspareunia.
* To correlate the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) with the long-term morbidity and quality of life.

Eligibility Inclusion criteria

* Adult patients (age \> 18 years) with primary localized RSTS surgically treated at our institution
* Written, voluntary, informed consent

Exclusion criteria

- Recurrent disease

Study description This is an observational study aimed to prospectively evaluate the long term morbidity of aggressive surgical approach to RSTS and the impact over the patients' quality of life. Consecutive patients candidate to surgery for primary RSTS will be offered to be enrolled. We plan to include all the RSTS patients consecutively operated on for primary retroperitoneal sarcoma from first accrual on up to the 24 months after the study start.

At the entrance of the study, an informed written consent will be obtained. Study participants will be asked to complete four self-filled in one-off questionnaires (see "Study parameters" paragraph).

Study parameters Study parameters EORTC QLQ-CR29 and EORTC QLQ C30 questionnaires (baseline, 4 mos, 12 mos) LEFS questionnaire (baseline, 4 mos, 12 mos) BPI questionnaire (baseline, 4 mos, 12 mos) DN4 questionnaire (baseline, 4 mos, 12 mos) Serum creatinin (baseline, 4 mos, 12 mos) Morbidity events (4 mos, 12 mos) Neurologic exam of lower limbs (baseline, 4 mos, 12 mos) Disease status (4 mos, 12 mos)

\* In case of preoperatory complementary treatment, the questionnaires will be administrated just before the beginning of the treatment.

* Quality of Life: the core questionnaire, the EORTC QLQC30,is an extensively validated questionnaire for the assessment of health related quality of life in cancer patients (Aaronson 1991). It contains both functional (physical, role, cognitive, emotional, social), and physical symptom multidimensional scales (fatigue, pain, and nausea and vomiting) as well as two single item "global health status" and "quality of life" scales, plus several single-item symptom measures. The QLQ-CR29 is a condition specific module (colo-rectal disease) developed to be used in conjunction with EORTC QLQC30; it is made up of 29 items for a total of four scales assessing urinary frequency, faecal seepage, stool consistency and body image as well a number single items scales. Both the tools are available and validated in the Italian language.
* Femoral Impairment: the dedicated questionnaire (Lower Extremity Functional Scale - Italian Version, LEFS questionnaire) will investigated daily life activities that require ad adequate function of knee joint stability and quadriceps strength as a surrogate of motor impairment of homolateral femoral nerve.
* Chronic Pain Syndrome: the Italian version of the 'Brief Pain Inventory Short form" (BPI, attached) ( ) will be administered in order to obtain information on pain status at censored time (basal, 4 and 12 months after surgery values).
* Neuropathic Pain: the Italian version of "Douleur Neuropathique en 4 Questions" (DN4, attached) will be administered in order to obtain information on neuropathic pain at censored time (basal, 4 and 12 months after surgery scores).
* Long term morbidity: morbidity events will specifically regard femoral nerve impairment at physical examination, abdominal complications, sexual life and physiological functions. Renal failure in particular will be investigated by renal function blood tests monitoring and glomerular filtration rate (GFR) calculated according to Cockroft-Gault and simplified MDRD (Modification of Diet in Renal Disease) methods. Serum creatinine value will also be registered. Renal failure will be defined according to National Kidney Foundation 2002 criteria (Stage 2 or higher), and classified according to GFR thresholds.
* Disease status will be recorded and in case of local and/or distant relapse the date of events will also be retrieved.

Statistical considerations Statistical analyses

1. Primary end-point The two-sided 95% confidence interval (95%CI) of the paired difference between baseline and 4 (or12) months scores will be calculated for the primary outcome scale variables (items "29" and "30" QLQ-C30).
2. Secondary end-points Descriptive statistics and frequency tabulation were used to summarize patient characteristics and long term morbidity profile. Continuous variables will be described with appropriate summary statistics such as the mean, median, standard deviation, minimum and maximum. Categorical variables will be tabulated with frequencies and percentages. The probabilities of renal failure and femoral neuropathy will be estimated by the corresponding relative frequencies; their corresponding 95% confidence limits will be calculated using the exact method, i.e. taking into account the binomial distribution of proportions. The binary associations between the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) will be tested by using exact chi-square test. As regards the quantitative parameters measured over time, summary statistics (mean, median, standard deviation, minimum and maximum) or frequencies and percentages - as appropriate for the type of data - will be summarized by each time point; mixed models will be used to analyze the longitudinal measurements, allowing to take into account the within subject correlation and to straightforwardly analyze unbalanced data that may arise in the study.

Interim Analysis We plan to performed an interim cross-sectional analysis at the end of patient enrollment in order to describe the study population at baseline, according to the primary and secondary endpoints.

Sample size

We plan to include all the RSTS patients consecutively operated on for primary retroperitoneal sarcoma from first accrual on for the next 24 months (about 60 patients estimated.

A sample size of 60 patients allows the estimation of a two-sided 95,0% confidence interval for the paired difference between baseline and post treatment scores with a precision (half CI width) of 0.25 times the standard deviation of the difference.

Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas

Long Term Morbidity and Quality of Life After Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study

Change between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0.

Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure.

Change between baseline and 4 and 12 months scores

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Attending Surgeon

A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)

CEUS-guided percutaneous biopsy

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

B-mode US-guided percutaneous biopsy

Zeno Spârchez, MD, Prof.

Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).

Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.

Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.

Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.

The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.

Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial

Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Iuliu Hatieganu University of Medicine and Pharmacy

Principal Investigator

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Wounds and Injuries

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Carcinoma

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Hyperthermia

Gastrointestinal Neoplasms

Fever

Wilms Tumor

Neuroblastoma

Peritoneal Neoplasms

Digestive System Neoplasms

Adrenocortical Carcinoma

Rhabdomyosarcoma

Desmoplastic Small Round Cell Tumor

Neoplasms, Glandular and Epithelial

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Myosarcoma

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Peritoneal Diseases

Ovarian Cancer

Wilms' Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Abdominal Surgery + CHPP of Escalating Cisplatin (Starting dose of 100 mg/m\^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.)

Starting dose of 100 mg/m\^2 intraperitoneally delivered as Continuous Hyperthermic Peritoneal Perfusion (CHPP) over 90 minutes at a flow rate of 1.5L/min and a peritoneal temperature of 42.5°Celsius.

CHPP of Cisplatin

Abdominal Surgery

Andrea Hayes-Jordan, MD

There has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in childhood tumors. Once this advanced stage of disease is evident, survival is measured in weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in adult clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma.

This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled.

Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases, this study will evaluate the safety of elevated temperature (40oC) with intraperitoneal cisplatin chemotherapy.

Primary Objectives:

1. To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors
2. To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials
3. To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)

Cisplatin has an atom at its center that contains platinum. The platinum is supposed to poison the cancer cells, causing them to eventually die. Sodium thiosulfate is designed to bind-up any Cisplatin that has escaped from the abdomen into the blood stream.

This is an investigational treatment which has been performed on two children on a compassionate use basis in North America. Both surgeries were performed at M.D. Anderson by the Study Chairman.

Before you can start receiving the study drugs, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. A physical exam will be performed, and you will have a computed tomography (CT) scan, or magnetic resonance imaging (MRI) scan to make sure the disease is only in the abdomen (stomach area). Blood (about 1 teaspoon) will be drawn for routine tests. You may have an echocardiogram (ECHO--a test to check heart function), and electrocardiogram (ECG--a test to measure electrical activity of the heart) if you have ever taken an anthracycline drug. An echocardiogram uses sound waves to make pictures of your heart, which helps show how well your heart pumps blood. You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size. Women who are able to have children must have a negative urine pregnancy test.

If you are found to be eligible, you will have a hearing test before your surgery and at your one-month evaluation.

If you are found to be eligible, the abdominal surgery will be performed to try to remove as many tumors as possible. The surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you.

If the doctor decides that you are eligible to receive the abdominal wash, a drug called sodium thiosulfate will be given through a needle in your vein. The abdomen will then be temporarily closed. Then the abdominal wash will begin. This will be done in the same room while you are under anesthesia. During the "abdominal wash," the heated cisplatin will be given into your abdomen and will "wash" over the area of the surgical procedure. There will be a pump attached to the plastic tubing and that will pump the drug in and out of your abdomen during that 90 minute period while the surgeon is gently compressing your abdominal wall so that the drug can reach all areas of your abdomen equally. After 90 minutes the drug is removed and your abdomen is 'washed' with saline. Then all the fluid is removed and the surgeon permanently closes your abdomen with 3 layers of stitches.

The actual dose level of cisplatin that you will receive will be decided when you enter the study. Participants on this study will be enrolled in groups of 3, and each group will be given a specific dose level of cisplatin. The first group will receive the lowest dose of cisplatin. If there are no severe or life-threatening side effects in this first group of patients, the next group will receive a higher dose of cisplatin and so on. This process of increasing the dose level for each new group of participants will continue until some patients have severe or life-threatening side effects. At that point, the dose level of cisplatin will be lowered and tested again in more participants.

Blood (about 1 teaspoon) will be drawn for routine tests. This testing will take place during the operation and every day until you leave the hospital.

After you leave the hospital, you will have a study visit about 1 month later, and then every 3 months for 6 months. At these visits, you will have a CT scan or MRI scan and a physical exam to check the status of the disease.

You will be taken off study if the disease gets worse or if you are disease free at or after your 6 month follow-up.

This is an investigational study. Cisplatin is FDA-approved and commercially available. Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer

A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Escalating Doses of Cisplatin for Children With Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease

The MTD is defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT).

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas	NCT03480399	Sarcoma, Soft T... Retroperitoneal... Surgery Quality of Life Morbidity		18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors	NCT05659433	Retroperitoneal...	CEUS-guided per... B-mode US-guide...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors	NCT05659433	Retroperitoneal...	CEUS-guided per... B-mode US-guide...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal Cancer	NCT00436657	Peritoneal Neop... Retroperitoneal... Gastrointestina... Adenocarcinoma Neuroblastoma Ovarian Neoplas... Sarcoma Adrenocortical ... Wilms Tumor Rhabdomyosarcom... Desmoplastic Sm...	CHPP of Cisplat... Abdominal Surge...	3 Years - 18 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for retroperitoneal neoplasms