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Adenocarcinoma clinical trials

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NCT ID: NCT01989858 Terminated - Clinical trials for Gastric Adenocarcinoma

ITACA-S2 (Intergroup Trial in Adjuvant Chemotherapy for Adenocarcinoma of the Stomach)

ITACA-S2
Start date: November 2010
Phase: Phase 3
Study type: Interventional

The study addresses two primary questions, according to its factorial design: - to compare the efficacy in terms of overall survival (OS) of a peri-operative vs. a post-operative chemotherapy (CHT) treatment, irrespectively of the presence of a post-surgical chemo-radiotherapy (CHT-RTX) (Timing Study); - to compare the efficacy in terms of relapse free survival (l-RFS) of a post-surgical CHT-RTX treatment vs. no other treatment, irrespectively of the timing of CHT (RTX Study). The study has a 2x2 factorial design, thus consisting of two independent, following specific eligibility criteria and with different randomization scheme studies, the Timing Study and the RTX Study. Both studies are Italian, multicentre, open-label, randomized, superiority, phase III trials conducted in patients with histologically confirmed, localized gastric adenocarcinoma, which is considered operable. In the Timing Study patients fulfilling the eligibility criteria will be randomized with a 1:1 ratio to receive: - peri-operative CHT (Arm A) or - post-operative CHT (Arm B) Once randomized in the Timing Study, patients may also be randomized in the RTX Study to receive in addition to CHT a post-operative CHT-RTX treatment or no other treatment. This is possible since the randomization will be done in two steps: the first for the Timing Study for all the participating centres (peri-operative CHT vs. post-operative CHT) and the second one for the RTX Study, only for those centres with the radiotherapist willing and able to participate (post- surgical CHT-RTX vs. no other treatment). Thus the following four arms will be generated: - peri-operative CHT (Arm A) - post-operative CHT (Arm B) - peri-operative CHT + post-operative CHT-RTX (Arm C) - post-operative CHT + post-operative CHT-RTX (Arm D) The study will be conducted in more than one hundred experimental centres. Follow-up F(-up) procedures and timing of the visits will be consistent with current clinical practice. Based on case-mix of sample 1000-1180 patients are needed in the Timing study and 420-520 in the RTX study.

NCT ID: NCT01989624 Completed - Clinical trials for Pancreatic Adenocarcinoma

PAncreatic Adenocarcinoma in Hospital

APACH
Start date: October 18, 2013
Phase:
Study type: Observational

Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%. Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life. The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country. The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.

NCT ID: NCT01983410 Recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma

Start date: November 4, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to better understand why pancreatic cancer develops in some people who are known carriers of the gene mutation (an abnormality) called BRCA, or its close relative PALB2. The investigators hope to do this by establishing a BRCA/PALB2 mutation carriers Pancreatic Ductal Adenocarcinoma (the common form of pancreatic cancer) Registry. A registry is a database of information.

NCT ID: NCT01971281 Active, not recruiting - Clinical trials for Pancreatic Adenocarcinoma

Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA)

Start date: November 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The study is a prospective, double arm, non-randomized, open label pilot trial, designed to study the safety, feasibility and preliminary efficacy of a medical device, the NovoTTF-100L concomitant with gemcitabine or concomitant with gemcitabine plus nab-paclitaxel, for front-line therapy of pancreatic adenocarcinoma. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT01971034 Completed - Clinical trials for Pancreatic Adenocarcinoma Advanced or Metastatic

Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Start date: June 2011
Phase: Phase 2
Study type: Interventional

In Brazil pancreatic adenocarcinoma represents 2% of tumors, and 4% mortality being an uncommon disease, however very aggressive.Only 20% of cases are indicated for curative surgery, of which only 20% are alive within 5 years. For locally, advanced or metastatic disease, since 1997, single chemotherapy with gemcitabine is the standard treatment for first line, with survival around 6 months approximately.There is no standard treatment regimen for second-line, however Paclitaxel demonstrated effect on second-line phase II study. Metformin is an oral hypoglycemic drug used for treatment of diabetes mellitus. There is a growing number of preclinical studies which show antitumor effect against pancreatic adenocarcinoma, probably due to the effect of anti-insulin growth factor (IGF-1). This study will add metformin to standard treatment for second line of locally advanced or metastatic pancreatic adenocarcinoma in ICESP previously treated with gemcitabine. The objective is to evaluate whether metformin improves the efficacy of the standard treatment with paclitaxel by clinical and radiological evaluation.

NCT ID: NCT01970540 Completed - Clinical trials for Neuroendocrine Tumors

Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors

Start date: May 25, 2011
Phase: Phase 1
Study type: Interventional

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types [i.e. small cell lung cancer (SCLC) and endometrial cáncer] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.

NCT ID: NCT01970306 Completed - Clinical trials for Esophageal Adenocarcinoma

Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Start date: October 18, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.

NCT ID: NCT01968317 Completed - Clinical trials for Endometrial Adenocarcinoma

Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.

NCT ID: NCT01964287 Completed - Clinical trials for Metastatic Pancreatic Adenocarcinoma

First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

GABRINOX
Start date: September 24, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.

NCT ID: NCT01962909 Terminated - Clinical trials for Pancreatic Ductal Adenocarcinoma

Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Start date: November 2013
Phase: Phase 0
Study type: Interventional

The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.