Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Childhood Brain Stem Glioma

Neuroepithelioma

A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week , by conformal radiotherapy sparing of the supratentorial brain. The planning target volume included the tumor as defined by the T2-weighted MRI images with a margin of 1.5-2.0 cm. Margins were adjusted for bony structures and tentorium. With exception of steroids, no neoadjuvant, concomitant, or adjuvant systemic treatment was allowed

The same planning and treatment procedures will be performed with the established conventional regimen: 54 Gy in 30 fractions giving 1.8 Gy per fraction.

A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week

Hypofractionated radiotherapy

A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.

Conventional arm

Mohamed s zaghloul, MD

Hypofractionated radiotherapy reduce the patient and family burden through decreasing the overall treatment time. This study is to evaluate the clinical end results of the hypofractionated radiotherapy in DIPG compared to the conventional treatment. The non-inferiority of the hypofractionated radiotherapy will result in decrease the hospital, stay or engagement, for more than its half with the same results.

In lack of open study protocols aiming to increase cure rate in pediatric diffuse intrinsic pontine glioma (DIPG), the investigators examined a hypofractionated radiotherapy regimen up to a dose of 39Gy in 13 fractions, completed in 2.5-3 weeks, instead of 6 weeks.

This schedule offers a reduction in patient burden, especially preferable in children with a poor compliance and performance status. The non-inferiority of the hypofractionated regimen in its clinical end-results, with the reduction of the overall treatment time to less than its half will decrease the burden for the patient, his/her family and the treating department. This will be considered as added value without compromising the survival or increasing side effects.

Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Prospective Randomized Trial of Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children.

Children's Cancer Hospital Egypt 57357

Nervous System Diseases

Diffuse Intrinsic Pontine Glioma

The same planning and treatment procedures will be performed. The total dose will be 4500 cGy in 15 fractions in 3 weeks; giving 300 cGy per fraction.

The same planning and treatment procedures will be performed with 54.0 Gy in 30 fractions giving 1.8 Gy per fraction.

Hypofractionated Arm (1)

The total dose to 4500 cGy in 15 fractions in 3 weeks

Hypofractionated Arm (2)

A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm

Conventional Arm (3)

This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.

In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.

Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

Prospective Randomized Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Pediatric Diffuse Brainstem Glioma

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Neoplastic Processes

All Drugs and Chemicals

Mitogens

Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).

In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.

lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)

Surgery

Surgery on Demand

Florian Fitzal, MD

Michael Gnant, MD

Guenther Steger, MD

Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy

This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children	NCT01635140	Pediatric Brain...	Hypofractionate... Conventional ar...	3 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children	NCT01878266	Pediatric Brain...	Hypofractionate... Hypofractionate... Conventional Ar...	2 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children	NCT01635140	Pediatric Brain...	Hypofractionate... Conventional ar...	3 Years - 18 Years	Children's Cancer Hospital Egypt 57357
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group
Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer	NCT01015625	Synchronous Met... Circulating Tum...	Surgery Surgery on Dema...	18 Years -	Austrian Breast & Colorectal Cancer Study Group
Hypofractionated Radiotherapy Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children	NCT01635140	Pediatric Brain...	Hypofractionate... Conventional ar...	3 Years - 18 Years	Children's Cancer Hospital Egypt 57357

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