Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)

Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)

Chemotherapy

Thierry Berghmans, MD

The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer

Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study

European Lung Cancer Working Party

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

All patients undergo standard neoadjuvant treatment and additional multi-parametric MRI and liquid biopsies during neoadjuvant treatment.

A blood sample containing circulating tumor DNA and circulating tumor cells.

Liquid biopsy

Multi-parametric MRI combines different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology.

Multi-parametric MRI

Kenneth GA Gilhuijs, PhD

The aim of the study is to show proof of concept for combining multi-parametric MRI with liquid biopsies in addition to conventional clinical and pathologic information, to accurately predict response to neoadjuvant treatment for patients with primary breast cancer.

The response to neoadjuvant chemotherapy (NAC) in early stage breast cancer has important prognostic implications. Early, dynamic prediction of response allows for adaption of the treatment plan before completion, or even before the start of treatment. This strategy can help prevent overtreatment and related toxicity and correct for undertreatment with an ineffective regimen. The hypothesis of this study is that accurate dynamic response prediction may be reached by combining multi-parametric MRI with liquid biopsies prior to, during and after NAC, in addition to conventional clinical and pathological information. Magnetic resonance imaging (MRI) is non-invasive and is typically used for response evaluation in current clinical practice. It shows the size and perfusion of the tumor as they change during treatment. However, tumor size on MRI has limited predictive value for response to therapy. Multi-parametric MRI uses different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology, and possibly improving predictive value. With this improvement, imaging still only visualizes macroscopic disease. Therefore, in the LIMA study, MRI will be combined with liquid biopsies containing circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA), which have both shown prognostic and predictive values in early stage breast cancer. Since the ctDNA may originate from cells in every part of the tumor, it may capture tumor heterogeneity. Liquid biopsies are minimally invasive and provide insight into microscopic tumor load and the tumor's genetic picture.

The aim of the study is to show proof of concept for combining multi-parametric MRI with liquid biopsies in addition to conventional clinical and pathologic information, to accurately predict response to neoadjuvant treatment for patients with primary breast cancer.

The LIMA is a multicenter prospective observational cohort study. Multi-parametric MRI will we performed prior to NAC, halfway and after completion of NAC. Liquid biopsies will be obtained before start of treatment, every 2 weeks during treatment and after completion of NAC. 100 patients will be enrolled in different hospitals.

Funding from the European Union Horizon 2020 research and innovation program under grant agreement no. 755333 (LIMA)

Liquid Biopsies and Imaging in Breast Cancer

Meta-data will be made publicly available. A steering committee will assess any request for reuse of the data.

The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

Measured in three dimensions as described in ACR BI-RADS Atlas® 5th Edition

Pathological complete response, defined as ypT0/ypN0

Horizon 2020 - European Commission

Philips Electronics Nederland BV

Agena Bioscience GmbH

DiaDx

Stilla Technologies

ANGLE Europe Limited

ALS Automated Lab Solutions GmbH

Institut National de la Santé Et de la Recherche Médicale, France

Philips GmbH Innovate Technologies

Institut du Cancer de Montpellier

UMC Utrecht

Associate Professor

Symptoms and General Pathology

Digestive System Diseases

Pathologic Complete Response

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Philippe Lambin, prof

Background of the study:

Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-\[18F\] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models.

Objective of the study:

The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.

Study design:

28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.

General objective

The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.

Aim of the study

The main aim is to validate a predictive model for pathologic complete response (ypT0N0) in rectal cancer patients treated with chemoradiotherapy by multi-centric prospective data collection. The second aim is to collect extra data for improvement of the accuracy of the prediction models with new variables. This new model will be validated later in the model development process.

Hypothesis

General hypothesis:

The validated accuracy of predictive models for pathologic complete response after chemoradiotherapy in rectal cancer patients is high enough to tailor treatment (surgery/non-surgery and/or administer extra radiation boosts) in clinical practice.

Specific hypotheses:

1. The performance of the developed models on the validation data is at least equal to the performance achieved during the model development process.
2. The performance of a new model based on the addition of variables performs better than the previous model

Validation of a Predictive Model After Complete Response in Rectal Cancer

Prospective Validation of a Predictive Model for Pathologic Complete Response After Chemoradiotherapy in Rectal Cancer: A Prognostic Study

Maastricht Radiation Oncology

Rare Diseases

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Oculocerebral Syndrome With Hypopigmentation

The gene polymorphism of ERCC1 rs11615 and the pathways of ERRC1 will be analyzed in endoscopic tumor biopsies as well as in normal tissues prior to therapy. The results will be compared with histopathologic response after neoadjuvant therapy.

ERCC1 pathways analysis

Arnulf H. Hölscher, MD

RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by preoperative chemoradiation. But only those patients have a benefit from this additional therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to identify before starting the therapy those patients who response.

PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients with cancer of the esophagus.

Cologne Esophageal Response Prediction Study (CERP-Study)

Prospective Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of ERCC1 in Response to Treatment With Neoadjuvant Radiochemotherapy in Patients With Esophageal Cancer

Patients with cT3 esophageal cancer received RTx/CTx according a standardized protocol. 6 weeks after this neoadjuvant therapy a tranthoracic esophagectomy with two-field lymphadenectomy will be performed.

The histopathologic response is measured using the surgical specimen.

All patients get a standardized follow-up every three month evaluating clinical signs of response. If necessary additional diagnostic procedures will be performed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer	NCT00864266	Non Small Cell ...	Chemotherapy	18 Years -	European Lung Cancer Working Party
Liquid Biopsies and Imaging in Breast Cancer	NCT04223492	Breast Cancer	Liquid biopsy Multi-parametri...	18 Years -	UMC Utrecht
Validation of a Predictive Model After Complete Response in Rectal Cancer	NCT00969657	Rectal Cancer		18 Years -	Maastricht Radiation Oncology
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer	NCT00864266	Non Small Cell ...	Chemotherapy	18 Years -	European Lung Cancer Working Party
Cologne Esophageal Response Prediction Study (CERP-Study)	NCT00953511	Esophageal Canc...	ERCC1 pathways ...	18 Years -	University of Cologne
Liquid Biopsies and Imaging in Breast Cancer	NCT04223492	Breast Cancer	Liquid biopsy Multi-parametri...	18 Years -	UMC Utrecht
Cologne Esophageal Response Prediction Study (CERP-Study)	NCT00953511	Esophageal Canc...	ERCC1 pathways ...	18 Years -	University of Cologne

Spots Global Cancer Trial Database for response prediction