Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Escalating doses of stereotactic body radiation therapy (SBRT)

Starting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease

Stereotactic Body Radiotherapy

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention (in this case, the stereotactic radiation boost). Phase I studies also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the stereotactic radiation treatment is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved a stereotactic radiation boost for your type of cancer.

In this research study, the investigators are looking for the highest dose of the stereotactic radiation boost that can be given safely. Because the stereotactic radiation boost is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects you experience; the goal is to improve the likelihood of successfully treating the tumor.

After confirming that you are eligible for this study and your willingness to participate in it, we will perform a radiation treatment stimulation, or "mapping session," within the next two weeks. You may or may not receive intravenous contrast during the process, which allows your physician to better see the blood vessels in your neck. You will be placed in a mask during this process to help keep you in the same place during each treatment. All of this is part of standard radiation treatment.

Approximately 14 days later, you will start radiation treatment to your primary tumor site and to your lymph nodes and chemotherapy in the same week. The chemotherapy will continue to be given one time per week during each week of treatment. You will receive radiation treatment 5 days a week for seven weeks. One day each during the first and second weeks of treatment, instead of the typical radiation dose, you will receive a dose of the stereotactic radiation boost to the site of the primary tumor (total of 2 doses of stereotactic radiotherapy).

Because we are looking for the highest dose of the stereotactic radiation boost that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the stereotactic radiation boost. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. We are testing 3 different dose levels for the stereotactic radiation boost; your dose will be one of those 3 doses.

The chemotherapy will be given one time per week, each week, for the duration of the radiation treatment (7 weeks). The chemotherapy is delivered through intravenous fluids that run through a vein in your arm. This is the same chemotherapy that you would receive if you were not participating in the study.

You will be seen by your radiation oncologist at least once every week during treatment.

After the final dose of radiation treatment all subsequent follow-up visits and tests are performed in accordance with standard cancer care. You will see your radiation oncologist, with or without the medical oncologist, at the following time intervals: 1 week after treatment ends, 1 month after treatment ends, 2 months after treatment ends, and then every 3 months for two years. You will undergo a PET-CT scan and neck CT scan at the time of the 3 month appointment.

You will be on the study treatment for about 7 weeks and your progress will be followed as part of the study for 2 years after treatment ends.

Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma

Stereotactic Boost for Poor-Prognosis Oropharyngeal Squamous Cell Carcinoma

Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for poor-prognosis oropharyngeal squamous cell carcinoma

Local failure is defined as biopsy-proven recurrent disease

To evaluate the safety and tolerability of a stereotactic boost to chemoradiotherapy, including both acute and long-term toxicity

To determine the 2 year overall survivial

To determine the 2-year disease-free survival

Dana-Farber Cancer Institute

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression

cabazitaxel

Abiraterone 1000mg daily (oral) until disease progression

Abiraterone

Enzalutamide 160mg daily (oral) until disease progression

Enzalutamide 160mg daily (oral)

Kim N Chi, MD

The purpose of this study is to assess and compare the clinical benefit rate in patients with metastatic castrate-resistant prostate cancer and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for \> or equal to 12 weeks, in the absence of other indicators of progression.

There is option to cross-over onto the other arm if the patient progresses.

Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer

A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer

To assess and compare the clinical benefit rate in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for greater than or equal to 12 weeks, in the absence of other indicators of progression.

To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B

To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.

To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.

Sanofi

Ozmosis Research Inc.

British Columbia Cancer Agency

Symptoms and General Pathology

Wounds and Injuries

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Hyperthermia

Fever

Adrenocortical Carcinoma

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Adenocarcinoma

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cisplatin

Sodium thiosulfate

Antidotes

Protective Agents

Antioxidants

Antitubercular Agents

Anti-Bacterial Agents

Chelating Agents

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

Cytoreductive surgery

sodium thiosulfate will be given to limit the toxicity of cisplatin

sodium thiosulfate

Jeremy L Davis, M.D.

Background:

- Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed. Those whose tumors have spread inside their abdomen may have an especially poor outcome. In these cases, traditional chemotherapy is not very effective. One possible new treatment is aggressive surgery with heated chemotherapy. This type of treatment has been more effective for other types of cancer in the abdomen. Researchers want to see this if approach can improve the outcomes of people with ACC.

Objectives:

- To test the safety and effectiveness of surgery and heated chemotherapy for ACC.

Eligibility:

- Individuals at least 18 years of age who have advanced ACC.

Design:

* Participants will be screened with a physical exam and medical history. Blood samples will be collected. Heart function tests will be given. Imaging studies will be used to locate the surgical sites before the operation.
* Participants will have surgery to remove ACC tumor tissue. After the tumors have been removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any remaining cancer cells and make them easier to destroy. It will also focus the treatment on the tumor sites, rather than the whole body.
* Participants will recover in the hospital for several days after surgery. They will have regular follow-up visits to monitor the outcome of the surgery.

Background:

* Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per million people per year and has a very poor prognosis with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months.
* The treatment of choice for a localized primary or recurrent tumor is surgical resection. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used.
* Cisplatin is one of the most effective chemotherapeutic agents for ACC. In the Surgery Branch we have conducted Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin for primary peritoneal mesothelioma, low grade appendiceal adenocarcinoma, ovarian malignancies, and high grade adenocarcinoma of the gastrointestinal tract. Synergy has been demonstrated for cisplatin and hyperthermia.
* The purpose of this trial is to determine if an aggressive surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.

Objectives:

- To determine IP progression free survival after optimal debulking and heated IP chemotherapy with cisplatin in patients with IP spread of adrenocortical cancer

Eligibility:

- Histologically proven ACC evaluable by computed tomography (CT) imaging with the majority of disease confined to the peritoneal cavity and surgically resectable to a residual size of less than 1 cm or amenable to radiofrequency ablation in patients who are \> 18 years of age.

Design:

- This is a classic phase 2 trial to determine efficacy of this therapeutic strategy in ACC. Patients will undergo cytoreductive surgery to achieve a CCR of 0 or 1.

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Patients will be evaluated by associate investigators in coordination with the Principal Investigator for eligibility. Due to its exploratory nature, up to 30 patients may be enrolled to obtain 24 evaluable patients. (Patients must undergo successful debulking and HIPEC to be considered evaluable.)

Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Amount of time subject survives without intraperitoneal disease progression after treatment. Disease progression is defined as imageable tumor nodules or increasing ascites persistent on computed tomography (CT) scan as interpreted by the official interpretation of the imaging studies.

Patients who died following the HIPEC procedure. The HIPEC is a surgical procedure in which two large bore catheters are inserted in the abdominal wall over the liver and pelvis. The physician closes the abdominal fascia and the catheters are connected to a perfusion circuit. The temperature of the catheters is carefully monitored while the physician ensures the perfusion is distributed properly by manually moving the abdomen.

Percentage of participants who are alive after treatment.

QOL characteristics were collected using The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (QOL) questionnaire version 4, a validated survey that interrogates physical, emotional, functional, and social well being in cancer related issues on a 5-point scale. Scores range from 0 to 108 points. Higher scores are consistent with a better outcome.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

National Cancer Institute (NCI)

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin

Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin

Cytoreductive Surgery Followed by HIPEC

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Stage I

Stage II

Stage III

Stage IV

Unknown

American Joint Committee on Cancer (AJCC) - Tumor Stage I-IV with Stage I being the least advanced cancer with the best prognosis, and Stage 4 being the most advanced cancer with the worst prognosis.

Tumor Stage (AJCC) at Diagnosis

Dr. Jeremy Davis

One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.

Intraperitoneal Progression Free Survival (PFS)

Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure

Nine patients underwent cytoreduction and HIPEC, including one patient who recurred and was re-treated (n = 10 treatments). One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.

Percentage of Participants Who Survived 5-years Post Treatment

Prior to surgery

6 weeks after surgery

3 months after surgery

One patient could not be optimally cytoreduced for hyperthermic intraperitoneal chemotherapy (HIPEC) and therefore did not receive intraperitoneal chemotherapy.

The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (FACT-G) (QOL) Score Prior to Surgery, 6 Weeks After Surgery, and 3 Months After Surgery

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Analgesics

Antirheumatic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Etoposide

Cytarabine

Mitoxantrone

Cyclophosphamide

Dexamethasone

Prednisone

Rituximab

Vincristine

Melphalan

Epirubicin

Lenograstim

Dexamethasone acetate

Etoposide phosphate

Carmustine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Tubulin Modulators

Antimitotic Agents

Antibiotics, Antitubercular

Adjuvants, Immunologic

(G-CSF 5 μg/Kg/day) from day 5 to day 11

Granulocyte-colony-stimulating factor

2 g/m2/12 hours for six doses in 3-hour infusion

Cytarabine ARA-C

4 mg/m2/12 hours before ARA-C administration

Carmustine BCNU

Radiotherapy

PBSC reinfusion

Umberto Vitolo, MD

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score

Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Behaviors and Mental Disorders

Thyroid Diseases

Thyroid Neoplasms

Aggression

Thyroid Cancer, Papillary

Adenocarcinoma, Papillary

Papillary Thyroid Carcinoma

This mutation will be analysed using the tumor tissues of the patients operated for thyroid diseases and diagnosed with papillary thyroid carcinoma. And mutation positive patients will be investigated for the aggressive characteristics of the tumor.

BRAF V600E mutation analysis will be made using the tumor tissues of the patients with papillary thyroid cancer (3 sections of 7 mm from he paraffin blocks). And mutation positives and negatives will be identified.

BRAF V600E POSITIVITY

Yeliz E Ersoy, DR

Yeliz E Ersoy, M.D.

The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stereotactic Boost for Oropharyngeal Squamous Cell Carcinoma	NCT01586182	Squamous Cell C...	Stereotactic Bo...	18 Years - 80 Years	Dana-Farber Cancer Institute
Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer	NCT02254785	Metastatic Cast...	cabazitaxel Abiraterone Enzalutamide 16...	18 Years -	British Columbia Cancer Agency
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma	NCT01833832	Adrenocortical ... Peritoneal Carc...	Cisplatin Cytoreductive s... sodium thiosulf...	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma	NCT00556127	Diffuse Large B... POOR PROGNOSIS	Rituximab Epirubicin Cyclophosphamid... Vincristine Prednisone Granulocyte-col... Mitoxantrone Cytarabine ARA-... Dexamethasone Carmustine BCNU Etoposide Melphalan Radiotherapy PBSC reinfusion	18 Years - 60 Years	Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
BRAF V600E Mutations In Papillary Thyroid Carcinoma	NCT01417442	Papillary Thyro...	BRAF V600E POSI...	-	Bezmialem Vakif University
Treatments for Brain Metastases With Poor Prognostic Factors	NCT05609162	Brain Metastase...	neurosurgical r...	-	Sun Yat-sen University
BRAF V600E Mutations In Papillary Thyroid Carcinoma	NCT01417442	Papillary Thyro...	BRAF V600E POSI...	-	Bezmialem Vakif University
Treatments for Brain Metastases With Poor Prognostic Factors	NCT05609162	Brain Metastase...	neurosurgical r...	-	Sun Yat-sen University

Spots Global Cancer Trial Database for poor prognosis