Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Renal Cell

Sarcoma

Osteosarcoma

Wilms Tumor

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Kidney Neoplasms

Rhabdomyosarcoma

Rhabdoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplastic Processes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Wilms' Tumor

Ewing Sarcoma

Neuroepithelioma

Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Stereotactic Body Radiotherapy (SBRT)

Karen Marcus, MD

This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

DLTs are defined as follows:

Grade 2 or higher toxicities:

* Myelitis
* Esophageal fistula, perforation, hemorrhage

Grade 3 or higher toxicities considered to be a direct result of therapy:

* Pneumonitis
* Pericarditis, pericardial effusion
* Esophageal necrosis, stenosis, ulcer
* Dyspnea

Grade 4 toxicities:

* Esophagitis
* Pericardial tamponade
* Pulmonary toxicity excluding infectious pneumonia
* Skin toxicity
* Hemoptysis/pulmonary hemorrhage

Grade 5 toxicities, including:

* Pulmonary toxicity including pneumonitis
* Excluding infectious pneumonia

Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.

Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.

Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.

Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.

Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.

Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.

Dana-Farber Cancer Institute

Karen J Marcus, M.D.

Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase I]

Cohort 2 Dose Level 2 [Phase II]

Cohort 2 Dose Level 2 [Phase I and II]

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Primary Tumor Histologies

Number of Lesions

The study had small sample size / weak accrual.

Karen Marcus MD

Number of Participants With Dose Limiting Toxicity [Phase I]

It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis

Overall Response Rate [Phase II]

Complete Response Rate [Phase II]

2 Year Local Control Rate [Phase II]

Percentage of Participants With 2-Year Failure-Free Survival [Phase II]

Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]

Overall Study

Behaviors and Mental Disorders

Quality of Life

Analgesics

All Drugs and Chemicals

The patients in the intervention group received multidisciplinary collaborative team care combined with palliative care.

The control group was given routine nursing intervention.

Doctors carried out health education for patients to avoid patients giving up their lives, encouraged them to actively cooperate with medical staff, and instructed patients on how to face the disease with a brave and strong attitude and actively fight the disease. Nurses conducted daily psychological counselling for patients, learnt their inner thoughts through communication with patients, and provided timely comfort and encouragement. An attention-shifting method can be used to alleviate the patient's attention to the disease, effectively improving internal depression and avoiding depression. For patients with anxiety and loneliness, family members were instructed to accompany and care.

Health education

Reasonable control of indoor temperature and humidity is necessary to ensure that warm, light conditions permit properly dressed patients to feel warm. Nurses need to ensure that patients are kept clean and tidy in personal hygiene. They would regularly assist patients in turning over while giving patients sufficient respect.

Comfort care

Clinicians should regularly evaluate the patient's physical pain and give reasonable analgesic drugs to patients. Nurses should closely observe the medication response of patients. At the same time, it is necessary to observe and record patients' physical pain daily and take effective pain control measures.

Pain care

The clinical nutritionist formulated appropriate nutritional diets according to the nutritional status and personal preferences of patients, provided nutritional support for patients, and followed up with patients once a week after discharge to improve their nutritional status.

Dietary care

Two nurses with psychological counselling qualifications in the team used the anxiety and depression scale to evaluate the psychological and emotional status of patients and referred to "The Questionnaire Survey on Awareness of Palliative Care" by the Department of Elderly Section of the union medical college hospital. The content mainly included the patient's medical history and general situation, the needs and awareness of patients and their families for palliative care, the choice of patients and their families for the final treatment plan, and the needs of families for grief counselling. Timely professional counselling and intervention were undertaken to alleviate the patient's adverse emotions.

Psychological and social support care

The control group was given routine nursing intervention, strictly in accordance with a routine treatment process, monitoring the vital signs of patients, giving basic nursing, health education, diet guidance and so on.

routine nursing intervention

This study proposed a multidisciplinary collaborative team combined with a palliative care model and proposed to establish a team composed of medical staff in various disciplines to make up for the defects of a conventional nursing team. This study applied the multidisciplinary collaboration team combined with a palliative care model to patients with terminal cancer to evaluate its clinical effect.

The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer

The Clinical Effect Evaluation of Multidisciplinary Collaborative Team Combined With Palliative Care Model in Patients With Terminal Cancer: A Randomised Controlled Study

This involved 20 items, of which the 5th, 9th, 13th, 17th and 19th items were reverse scoring, and the 1-5 items were positive scoring. The items were scored according to Likert4 grade. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more severe the anxiety state. A score \<50 showed no anxiety, 50-59 showed mild anxiety, 60-69 showed moderate anxiety, and \>70 showed severe anxiety

There are a total of 20 entries, of which 10 are scored by forward and 10 by reverse. The entries are scored by Likert4 level. The sum of the scores of each item is the total score of the scale. The scores were converted to a standard score: standard score = total anxiety score×1.25. The higher the score, the more serious the depression. A score ≤50 showed no depression, 50-59 showed mild depression, 60-69 showed moderate depression, and \>70 showed severe depression

The scale was with a total of 10 items, including three dimensions of subjective support, objective support and utilisation of support. The total score of the scale is the sum of the scores of the three dimensions, and the higher the score, the greater the social support. Judgement criteria: A total score of ≤22 indicates a low level, 23-44 indicates a moderate level, and 45-66 indicates a high level, with a domestic norm score of 34.56±3.73

QLQ-C30 consists of one overall QOL scale and five functional scales. The functional scales include physical function, role function, emotional function, cognitive function and social function. Rating criteria: After the scores of each part of the scale are converted to standardised scores, and the score range is 0-100. The higher the score on the scale, the better the overall QOL and functional status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors	NCT02581384	Ewing Sarcoma Rhabdomyosarcom... Wilms Tumor Osteosarcoma Non-Rhabdomyosa... Renal Tumor Rhabdoid Tumor Clear Cell Rena... Sarcoma Sarcoma, Ewing Soft Tissue Sar...	Stereotactic Bo...	- 21 Years	Dana-Farber Cancer Institute
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors	NCT02581384	Ewing Sarcoma Rhabdomyosarcom... Wilms Tumor Osteosarcoma Non-Rhabdomyosa... Renal Tumor Rhabdoid Tumor Clear Cell Rena... Sarcoma Sarcoma, Ewing Soft Tissue Sar...	Stereotactic Bo...	- 21 Years	Dana-Farber Cancer Institute
The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer	NCT05683236	Multidisciplina... Palliative Care... Quality of Life	Health educatio... Comfort care Pain care Dietary care Psychological a... routine nursing...	-	Shijiazhuang People's Hospital
The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer	NCT05683236	Multidisciplina... Palliative Care... Quality of Life	Health educatio... Comfort care Pain care Dietary care Psychological a... routine nursing...	-	Shijiazhuang People's Hospital

Spots Global Cancer Trial Database for comfort care

Every month we try and update this database with for comfort care cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.