Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Tissue specimen

Howard Safran, MD

The purpose of this study is to study which genes are abnormal in rectal cancer and see if this predicts how well chemotherapy and radiation will reduce the size of cancer and whether cancer recurs after surgery.

Specific gene mutations have become targets for specific therapies. For example lung adenocarcinomas with an EGFR (epidermal growth factor receptor) mutation can be targeted with an EGFR tyrosine kinase inhibitor achieve striking and durable responses and improved survival. Another example is the identification of the echinoderm microtubule-associated protein-like 4/anaplastic lymphoma kinase (ALK) gene fusions which have led to significant therapeutic gains in the small percentage of patients with lung adenocarcinoma whose cancers exhibit this mutation. Specific mutations have been found in colon cancer and specific drugs targeting these gene alterations are in development. As future therapeutic protocols specific for these mutations are developed, patients who agree may be notified of their eligibility for these studies.

The aims of this study are to link mutational analyses with clinical outcome. It is recommended that patients receive 8 cycles of mFOLFOX6 (modified FOLFOX) and 50.4 Gy radiation with concurrent fluoropyrimidine.

Tissue specimen from diagnosis from rectal cancer

Rectal Cancer Consortium

Rectal Cancer Consortium: BrUOG 285: A Comprehensive Program to Identify Therapeutic Targets and Develop Targeted Agents for Testing With Total Neoadjuvant Treatment for Stage II-III Rectal Cancer BrUOG= Brown University Oncology Research Group

Brown University

Principal Investigator

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.

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer

Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer, a Multicenter Prospective Randomized Study to Evaluate the Use of Local Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rectal Cancer Consortium	NCT01835925	Rectal Cancer	Tissue specimen	18 Years -	Brown University
Rectal Cancer Consortium	NCT01835925	Rectal Cancer	Tissue specimen	18 Years -	Brown University
Rectal Cancer Consortium	NCT01835925	Rectal Cancer	Tissue specimen	18 Years -	Brown University
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

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