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Pancreatic Neoplasms clinical trials

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NCT ID: NCT02391662 Completed - Clinical trials for Pancreatic Carcinoma Metastatic

Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma

Start date: June 23, 2015
Phase: Phase 2
Study type: Interventional

Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Since there is no specific recommendations for treatment of elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of choice for these patients. Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and targeted agents to gemcitabine has almost invariably provided no significant survival improvement. Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in overall survival, but due to in this clinical trial was included patients between 27 and 88 years, it is considered necessary to conduct a specific study for patients over 70 years. The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel associated with gemcitabine can be extended to elderly patients with pancreatic cancer.

NCT ID: NCT02382263 Completed - Clinical trials for Advanced Pancreatic Cancer

Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

FRAGANCE
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms. The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients. For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

NCT ID: NCT02381249 Completed - Weight Loss Clinical Trials

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

Start date: March 2015
Phase: N/A
Study type: Interventional

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment. Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited. Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery. In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

NCT ID: NCT02374411 Completed - Sarcoma Clinical Trials

Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Start date: September 2014
Phase: N/A
Study type: Observational

The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.

NCT ID: NCT02374255 Completed - Colorectal Cancer Clinical Trials

Improving Goals of Care Discussion in Advanced Cancer Patients

Start date: March 15, 2016
Phase: N/A
Study type: Interventional

The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.

NCT ID: NCT02362048 Completed - Clinical trials for Metastatic Pancreatic Cancer

ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Pancreatic Cancer

KEYNOTE144
Start date: May 2015
Phase: Phase 2
Study type: Interventional

ACP-196 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

NCT ID: NCT02358161 Completed - Pancreatic Cancer Clinical Trials

Phase I/II Study of LDE225 With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

MATRIX
Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The 5 year survival of patients with locally advanced or metastatic pancreatic cancer is less than 5 %. Since the introduction of gemcitabine, further advances in therapy in the advanced/metastatic setting have been extremely slow. Numerous phase III studies have evaluated different gemcitabine-based regimens as first-line therapy, but in most cases, any observed benefits have been small and restricted to patients with a good performance status (PS). Recently two new chemotherapy combination schedules, FOLFIRINOX and Gemcitabine + nab-paclitaxel demonstrated a significant survival improvement compared to gemcitabine alone. Nab-paclitaxel is especially interesting because it is able to break-down the tumor matrix and increases the concentration of cytotoxic drugs in the tumor. Our study will explore the modification of the desmoplastic reaction seen in pancreatic cancer using two approaches, targeting tumor stroma by nab-paclitaxel and the hedgehog inhibitor LDE225 and targeting the tumor cells with gemcitabine and nab-paclitaxel.

NCT ID: NCT02352337 Completed - Clinical trials for Metastatic Pancreatic Cancer

First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem

PANOPTIMOX
Start date: December 23, 2014
Phase: Phase 2
Study type: Interventional

The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy. Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin. These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years. FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment. The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

NCT ID: NCT02351219 Completed - Clinical trials for Pancreatic Carcinoma Stage III

FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer

FLAP
Start date: December 2012
Phase: Phase 2
Study type: Interventional

The study is conducted as a monocentric prospective phase II trial. Patients with unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are eligible. After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle. In case of tumors have deemed resectable surgery is considered. In case tumors remain unresectable, radiotherapy is evaluated after the end of chemotherapy. Primary objective of the study is the rate of patients who become resectable and undergo radical surgical resection after chemotherapy. Secondary objectives are: response rate, progression-free survival, overall survival, toxicity.

NCT ID: NCT02349867 Completed - Clinical trials for Pancreatic Adenocarcinoma

Neoadjuvant Chemotherapy Followed by Radiation Therapy and Gemcitabine/Sorafenib/Vorinostat in Pancreatic Cancer

Start date: January 29, 2015
Phase: Phase 1
Study type: Interventional

Determine the doses and schedule appropriate for phase 2 study of sorafenib and vorinostat with concurrent gemcitabine and radiation therapy (RT) as neoadjuvant treatment of pancreatic cancer following chemotherapy. Recommended phase II dose RP2Ds and schedule of sorafenib and vorinostat defined as the doses and schedule that are the same as or less than the maximum tolerated dose (MTD) and schedule.