Neoplasms

All Conditions

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Sorafenib

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Pre-operative Continuous 5-FU, and Sorafenib with External Radiation Therapy. Dose level -1 will only be evaluated if dose level 1 exceeds MTD. The sorafenib and infusional 5-FU will only be given Day 1-5(Monday-Friday) with radiation only.

In addition to radiation and 5-FU, sorafenib will be taken by mouth daily every day until the last day of radiation. The dose of sorafenib will be one of the following: 200 mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily

5-FU will be delivered at a dose of 225 mg/m\^2 daily through a catheter in a large vein continuously until the last day of radiation.

5-Fluorouracil (5-FU)

Radiation sessions will be daily, Monday through Friday, except for holidays.

Radiation

Richard Kim, M.D.

The main purpose of this study is to find the maximum tolerable dose of sorafenib when administered along with another drug called 5-Fluorouracil (5-FU) and to find out more about whether these drugs, along with radiation, can help people with rectal cancer when given before surgery. 5-FU and radiation are both approved by the US Food and Drug Administration (FDA) for use in people with rectal cancer.

The investigators will utilize a standard 3 + 3 phase I study design. In the phase I part of the study, the investigators will attempt dose escalation of sorafenib in combination with standard infusional 5-FU and external beam at standard doses. Clinical staging should be done by endorectal ultrasound (ERUS) and/or pelvic magnetic resonance imaging (MRI) for T and N stage; chest and abdomen computed tomography (CT) for staging of metastatic disease; undergo sigmoidoscopy and/or colonoscopy done by crude odds ratios (CORS); biopsy is taken for diagnosis and extra is sent for tissue bank. At the maximum tolerated dose (MTD) of sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile and efficacy.

Participants' study regimen will include 5 ½ weeks of radiation. Radiation sessions will be daily, Monday through Friday, except for holidays. 5-FU will be delivered at a dose of 225 mg/m² daily through a catheter in a large vein continuously until the last day of radiation. In addition, sorafenib will be taken by mouth twice daily every day until the last day of radiation. The dose of sorafenib participants may receive will be one of the following: 200 mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily. Following completion of this phase of the study, participants will receive no study drug or radiation for one month. At 4 to 5 weeks after stopping study drug and radiation, participants will have another CT scan or MRI to assess their cancer. About 6 to 8 weeks after the end of radiation, participants will undergo surgery and every effort will be made to remove the tumor. The surgery will occur just as it would if participants were not in the study, except that a portion of their tumor obtained during surgery will be used for research biomarker testing (as described in the consent form).

Approximately 6 -10 weeks after participants' surgery, when they have adequately healed, they may receive additional chemotherapy at their study doctor's discretion.

Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer

Phase I Study of Pre-operative Continuous 5-FU, and Sorafenib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma

To determine maximally tolerated dose of sorafenib when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinoma

To determine the pathologic response rate after pre-operative therapy and surgery

To further define safety profile of the combination. During the 5 1/2 weeks of radiation, participants will be seen in the study clinic and will have blood tests weekly.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gallium 68 PSMA-11

External radiation therapy

Adalsteinn Gunnlaugsson, MD, PhD

This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy.

A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.

Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

Prospective Evaluation of 68-Ga-PSMA -PET and Early PSA Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

Lund University Hospital

Gland and Hormone Related Diseases

Rare Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

Carcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

After the patient had diagnosed as anaplastic thyroid cancer, Nexavar was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.

operation for possible surgical treatment,with complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.

then External radiation therapy after surgery.

for Unresectable tumors ,After the patient had diagnosed as anaplastic thyroid cancer, Nexavar 400mg Bid was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.

Nexavar

If computed tomography (CT) evaluates for possible surgical treatment, complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.

operation

As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy

Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.

Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.

We chose patients with recurrent or inoperable anaplastic thyroid cancer and used NEXAVAR for 1 month of neoadjuvant therapy. If tumor lesions begin to resolve, they continue neoadjuvant therapy until the end of the second month. The total duration of preoperative treatment is two months.at the end of the second month, a CT scan was performed to assess whether surgery could be performed. If surgery is possible, NEXAVAR will continue to perform adjuvant radiotherapy after the surgery.

Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Length of contact surface between tumor and common carotid artery

Percentage of patients in whom the actual dose of sorafenib equaled the planned dose

Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause

Overall tolerability of treatment as measured by rate of adverse events

Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after treatment with NEXAVAR

Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death

Adverse events was evaluated during received protocol therapy according to CTCAE 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pre-operative 5-Fluorouracil (5-FU) and Sorafenib With External Radiation in Locally Advanced Rectal Cancer	NCT01376453	Rectal Cancer	Sorafenib 5-Fluorouracil ... Radiation	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy	NCT02699424	Relapsed Prosta...	External radiat...	18 Years -	Lund University Hospital
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer	NCT03565536	Thyroid Cancer,...	Nexavar operation External radiat...	18 Years -	Fujian Medical University
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer	NCT03565536	Thyroid Cancer,...	Nexavar operation External radiat...	18 Years -	Fujian Medical University

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