Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Herbal and Botanical

All Drugs and Chemicals

Cola

GAEL ROTH, MD, PHD

ARNAUD MILLET, MD, PHD

ARNAUD MILLET, MD,PHD

Colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. Thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. In order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. This project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. It will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. This study should in fine help to improve the cancer patient's care.

Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms

Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms: a Patient-derived Tumoroids Prospective Collection From Systemic Treatment Naive Tumors

University Hospital, Grenoble

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Starting dose of 48Gy in 3 fractions, will escalate dose by 2 Gy per fraction (a 6Gy total dose) to a maximum dose of 20Gy x 3 fractions (TD 60 Gy in 3 fractions).

Stereotactic Body Radiotherapy (SBRT)

Ronald D Ennis, MD

The purpose of this study is to evaluate the safety and efficacy of the use of stereotactic body radiotherapy (SBRT) for the treatment of the primary tumor in renal cell carcinoma (RCC) in medically inoperable patients and/or patients who refuse surgery. Standard treatment of RCC is surgery. A number of non-surgical treatments of RCC are also available, but are highly invasive and are associated with significant side effects. SBRT is a non-invasive, non-surgical treatment that requires tumor immobilization and image guidance in order to deliver a very precise, high-dose treatment. This trial will assess the use of SBRT to treat primary renal tumors by determining the maximum tolerated dose and toxicity. Subjects enrolled in this study will then be followed and evaluated for toxicity, serum chemistry, complete blood count, and urinalysis. In addition, they will undergo renal scans to assess the functionality of their renal tissue.

There is a need for a non-invasive treatment modality in renal cell carcinoma (RCC) patients who are medically or technically inoperable or refuse surgery. The primary tumor in patients with RCC is generally managed surgically or with a non-surgical ablative modality, but there is significant toxicity and invasiveness associated with current surgical and percutaneous treatment modalities. Stereotactic radiotherapy was first developed to treat brain metastases and other intracranial tumors by giving a single high-dose treatment delivered with a precision of less than 1 mm. This treatment requires immobilization of the tumor and precise imaging to guide the treatment. The brain is particularly amenable to this approach since there is no internal brain motion, the skull is easily fixed in position, and excellent imaging is available. Recent developments in immobilization and image guidance now permit precise tumor targeting of extracranial sites, such as the liver and lung. Stereotactic radiotherapy used at extracranial sites is called stereotactic body radiotherapy (SBRT). Because of the great precision of SBRT, a high dose per treatment is possible. Early work evaluating SBRT in primary and metastatic liver and lung tumors has shown excellent results in tumor control and toxicity. Based on this, we propose expanding the use of this technique to RCC.

In this study, the investigators seek to evaluate the safety and efficacy of SBRT for the treatment of the primary tumor in renal cell carcinoma (RCC). One goal of this study is to establish the maximum tolerated dose (MTD) of renal SBRT by determining the dose-volume relationship and toxicity for the kidney when high dose per fraction SBRT is used. In order to ensure proper immobilization and tumor localization, the investigators will use abdominal compression, 4D CT scanning at the time of simulation, and cone beam CT scanning at the time of treatment. The investigators propose to perform Tc-99m glucoheptonate renal scans before and after SBRT to assess renal tissue at the periphery of the lesion, as well as baseline and follow-up serum chemistry evaluation, creatinine, complete blood count, urinalysis, and creatinine clearance.

To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors

Phase I Trial of Stereotactic Body Radiotherapy (SBRT) of the Primary Tumor in Renal Cell Carcinoma (RCC)

A ≥20% increase in the sum of the diameters of the tumor with a minimum increase in the sum of 5 mm (RECIST criteria) or any areas of enhancement on follow up imaging studies is categorized as progression. Time to failure will be from the last date of SBRT to date of local failure or last follow-up.

* Local failure will be classified as in field if it occurs within the treated volume or marginal if it occurs at the edge of the treated volume.
* Development of a new renal tumor elsewhere in the kidney. This will not be considered a local failure. Time to development of a new tumor elsewhere in the kidney will be from the last date of SBRT to date of the event or last follow-up.

-Recurrence is renal hilar, para-aortic or para-caval lymph nodes.

Beth Israel Medical Center

Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days).

Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks.

All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.

ARQ 197

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).

ARQ 197 in Subjects With Metastatic Solid Tumors

A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

ArQule

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The peripheral blood sample will be extrated with DNA and performed NGS using Illumina Nextseq500 sequencer.

The gene testing of the primary tumor tissue diagnosed with nonsquamous NSCLC will be performed with NGS technique using Illumina Nextseq500 sequencer.

The gene testing of the metastatic lymph node tissue diagnosed with nonsquamous NSCLC will be performed with NGS technique using Illumina Nextseq500 sequencer.

The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.

Nextseq500 sequencer

Jiayuan Sun, MD,PhD

The objective of the study was to compare the gene mutation status among the primary tumor, matched metastatic lymph node (LN) and peripheral blood in advanced nonsquamous non-small cell lung cancer (NSCLC) using next-generation sequencing (NGS).

Many gene mutations have been detected in lung cancer, which might differ between the primary tumor and the metastases in a same patient. One may cause by the heterogenicity of the tumor, another may cause by the sensitivity of the detection technique. So we determine to use NGS, which is a more sensitive technique, to detect the different gene mutations among the primary tumor, metastatic LN and peripheral blood in advanced nonsquamous NSCLC.

The study was designed as a prospective and single center study. Thirty five patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the primary tumor and metastatic lymph nodes will be obtained by interventional pulmonology technology. And about 10ml peripheral blood will be collected at the same time. The tissue will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, the rest tissue will be extracted with DNA and performed NGS for the qualified DNA sample using Illumina Nextseq500 sequencer.The matched peripheral blood will also be extract with DNA and performed NGS using Illumina Nextseq500 sequencer.

Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS

Comparison of Gene Mutations Among the Primary Tumor, Matched Metastatic Lymph Node and Peripheral Blood in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing

Gene mutations in primary tumor, matched metastatic LN and peripheral blood samples will be tested using NGS technique.

Jiayuan Sun

Director, Endoscope Department, Shanghai Chest Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Genome analysis of tissue samples.

The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.

The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.

Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases

We will do profiling of the mRNA (messenger ribonucleic acid) expression of microRNA and perform single nucleotide polymorphism analysis of cancer tissue and compare the expression using statistical methods such as SAM (Significance analysis and microarrays), PAM (Prediction analysis of microarrays). In addition, we wish to perform specific genetic analysis of cancer-related genes. These will be made with available methods like sequencing or TaqMan assays for specific mutations.

Blood samples will be analysed by microarray methods for RNA and microRNA in addition to serum analysis of proteins.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms	NCT05038358	Primary Tumor Colon Tumor		18 Years -	University Hospital, Grenoble
To Evaluate Stereotactic Body Radiotherapy for Treatment of Primary Renal Cell Carcinoma Tumors	NCT02410174	Primary Tumor Renal Cell Carc...	Stereotactic Bo...	18 Years -	Beth Israel Medical Center
ARQ 197 in Subjects With Metastatic Solid Tumors	NCT00302172	Cancer Tumor	ARQ 197	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Comparison of Gene Mutations in Matched Samples in Advanced Nonsquamous NSCLC Using NGS	NCT02416726	Lung Cancer	Nextseq500 sequ...	18 Years - 80 Years	Shanghai Chest Hospital
ARQ 197 in Subjects With Metastatic Solid Tumors	NCT00302172	Cancer Tumor	ARQ 197	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
ARQ 197 in Subjects With Metastatic Solid Tumors	NCT00302172	Cancer Tumor	ARQ 197	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
ARQ 197 in Subjects With Metastatic Solid Tumors	NCT00302172	Cancer Tumor	ARQ 197	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases	NCT02301858	Lung Cancer Primary Tumor Metastases	Genome analysis...	18 Years - 90 Years	Sykehuset i Vestfold HF
Tumor Immune Microenvironment Involvement in Colorectal Cancer Chemoresistance Mechanisms	NCT05038358	Primary Tumor Colon Tumor		18 Years -	University Hospital, Grenoble

Spots Global Cancer Trial Database for primary tumor