Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Stomach Neoplasms

Pancreatic Neoplasms

Urinary Bladder Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gallbladder Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Stomach Cancer

Pancreatic Cancer

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Capecitabine

Oxaliplatin

Pancrelipase

Pancreatin

Antimetabolites

oxaliplatin, capecitabine, radiotherapy

Anders Johnsson, MD, PhD

The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.

CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant.

CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.

Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Roche Pharma AG

Sanofi-Synthelabo

Lund University Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Wounds and Injuries

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lung Injury

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Dirk De Ruysscher, PhD.

Bas Kietselaer, MD,Phd

Judith van Loon, MD,PhD

Philippe Lambin, Prof,MD,Phd

Anne-Marie Dingemans, MD, PhD

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value \<0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Bloodsamples and saliva samples will be collected according to the biobank protocol at Maastro clinic to explore the prognostic value of mitochondrial DNA for development of radiation-induced lung injury.

Cardiac bloodmarkers: B-type Natriuretic Peptide (BNP), cardiac Troponin I and T will be measured.

Haemoglobin and inflammatory parameters (CRP, IL-6 and TNFa)

Echocardiography for RILI Prediction

The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.

Academisch Ziekenhuis Maastricht

Maastricht Radiation Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer	NCT01016639	Stomach Cancer Gall Bladder Ca... Bile Ductus Can... Pancreas Cancer Colorectal Canc...	oxaliplatin, ca...	18 Years -	Lund University Hospital
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer	NCT01016639	Stomach Cancer Gall Bladder Ca... Bile Ductus Can... Pancreas Cancer Colorectal Canc...	oxaliplatin, ca...	18 Years -	Lund University Hospital
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer	NCT01016639	Stomach Cancer Gall Bladder Ca... Bile Ductus Can... Pancreas Cancer Colorectal Canc...	oxaliplatin, ca...	18 Years -	Lund University Hospital
Echocardiography for RILI Prediction	NCT02501707	NSCLC		18 Years -	Maastricht Radiation Oncology

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