Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Digestive System Diseases

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Lung Neoplasms

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Neoplasms by Histologic Type

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Neuroectodermal Tumors, Primitive

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Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

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Gastrointestinal Agents

Gemcitabine

Irinotecan

Docetaxel

Leucovorin

Fluorouracil

Cisplatin

Oxaliplatin

Liver Extracts

Folfirinox

Pancrelipase

Pancreatin

If you are assigned to this arm, study doctors will sequentially remove and treat all visible cancer spots with surgery, radiation, ablation, or other procedures. These interventions might include surgical removal of the diseased part of your lung, liver, lymph nodes, and/or the lining of your belly. In addition, if surgery could not be done, we could treat these diseased spots with other modalities such as radiation and/or radiofrequency/microwave ablation.

If you're selected to be in this arm, the type of procedure you receive will vary based on your cancer and what the study doctor recommends for treatment.

Participants in this arm receive the current standard of care chemotherapy for their specific type of gastrointestinal cancer. This treatment may include the continuation of chemotherapy and a few procedures which may improve your quality of life.

* If you have cancer of the stomach or food pipe (esophagus): the preferred chemotherapy regimen includes two or three medications. These drugs include Cisplatin or Oxaliplatin and 5-fluorouracil (5 FU) in combination with Docetaxel.
* If you have cancer of the pancreas or ampulla: the preferred chemotherapy medicines include Gemcitabine or a three-drug combination chemotherapy called FOLFIRINOX, which includes 5FU, Leucovorin, Irinotecan, and Oxaliplatin.
* If you have bile duct cancers: a combination of Gemcitabine, platinum agents, or fluoropyrimidine will be considered.

Standard of Care Chemotherapy

If you have lung cancer, you may receive video-assisted thoracic surgery (VATS): a type of minimally invasive thoracic surgery of the chest, performed with a thoracoscope (small videoscope) using small incisions and special instruments to minimize trauma.

Video-Assisted Thoracic Surgery (VATS)

If you have lung cancer, you may receive a lobectomy:

A major/invasive surgical procedure where an entire lobe of your lung is removed.

Lobectomy

A type of radiation treatment used to kill any cancer cells that may be left in the body. It may also include a stem cell transplant or treatment with drugs that kill cancer cells.

Consolidative Radiation

Depending on the location of you cancer and the state of your cancer after chemotherapy, you may receive on the the following ablation treatments:

-Microwave or Radiofrequency Ablation: Radiofrequency ablation (RFA) and microwave ablation (MWA) are treatments that remove liver tumors by placing a needle through the skin into the tumor. In RFA, high-frequency electrical currents are passed through an electrode in the needle, creating a small region of heat. In MWA, microwaves are created from the needle to create a small region of heat. The heat destroys the liver cancer cells.

-General Tumor Ablation Treatment: a minimally invasive surgical method to treat solid cancers. Special probes are used to "burn" or "freeze" cancers without the usual surgery. Doctors use images of your tumor to guide where they place the needle. This requires only a tiny hole, usually less than 3 mm via which the probe is introduced.

Ablation Treatment

Depending on the type of GI cancer you have and the state of your cancer after chemotherapy, you may receive a resection or excision: a surgical procedure that focuses on removing all or part of a tumor/organ/body using a sharp knife (scalpel) or other cutting instrument.

Resection or Excision

Peritonectomy is a surgery used to remove peritoneal tumors (tumors in the lining of the abdomen/stomach) from a patient. Following surgery, a heated chemotherapy bath (HIPEC) is commonly administered.

Peritonectomy

If you have cancer in your biliary tract (gallbladder, pancreas or liver), you may receive transarterial radioembolization known as TARE.

TARE allows doctors to deliver radiation treatment directly to the liver using a minimally invasive technique that is designed to cause few side effects. TARE allows doctors to thread a catheter through a small incision in the participant's upper thigh through the artery that goes directly to the liver.

Transarterial Radioembolization

Kiran Turaga, MD

This study is designed for participants who have cancer of the upper gastrointestinal (GI) tract such as cancer of the esophagus, stomach, duodenum (the initial portion of your small intestine), pancreas, bile duct (Cholangiocarcinoma), ampulla, or gall bladder with limited sites of spread (metastases). Doctors leading this study are looking to see if treating the disease using sequential procedures (more than one procedure given one after another) such as surgeries or radiation can lead to better survival and if these surgeries, combined with standard of care treatment, are safe for the treatment of upper GI cancers.

This study is designed for participants who have cancer of the upper gastrointestinal (GI) tract such as cancer of the esophagus, stomach, duodenum (the initial portion of your small intestine), pancreas, bile duct (Cholangiocarcinoma), ampulla, or gall bladder with limited sites of spread (metastases).

Doctors leading this study are looking to see if treating the disease using sequential procedures (more than one procedure given one after another) such as surgeries or radiation can lead to better survival and if it is safe for the treatment of upper GI cancers.

The purpose of the proposed study is to identify a group of patients with metastatic cancer of the upper GI and biliary tract that may benefit from sequential procedures such as surgeries or radiation compared to the current standard of care chemotherapy treatment alone.

Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels

Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Interventions for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

The progression free survival (PFS) of participants undergoing sequential procedures (Arm A of study) vs standard of care chemotherapy (participants in Arm B - control group) as assessed by clinical records. Progression free survival will be defined as the time from randomization to first documented disease progression or death as assessed by clinical records.

The percentage of participants in each arm without disease progression/death at 6 months as assessed by clinical records.

The percentage of participants in each arm without disease progression/death from randomization to progression on second line therapy, which includes repeat interventions.

The percentage of participants in each arm without disease progression/death at 12 months as assessed by clinical records.

The median overall survival of participants undergoing sequential procedures (Arm A) vs standard of care therapy (Arm B) as assessed by clinical records. Median overall survival will be defined as the time from randomization to death from any cause.

Health-related quality of life (HRQoL) for participants undergoing sequential procedures (Arm A) vs. the HRQoL for participants receiving standard of care treatment (Arm B). This will be assessed by quality of questionnaires completed by participants at baseline and after treatment.

The financial burden and its consequences faced by participants undergoing sequential procedures vs. the financial burden experienced by participants receiving standard of care treatment (Arm B). This financial burden/toxicity will be assessed by the Comprehensive Score for Financial Toxicity (COST) questionnaire, a standardized participant-friendly questionnaire used to measure financial toxicity/burden of treatment.

The morbidity (the state of having a particular illness) of participants after undergoing sequential cytoreductive procedures (procedures used to remove tumors) as assessed by clinical records.

The mortality (the number of deaths) of participants after undergoing sequential cytoreductive procedures (procedures used to remove tumors) as assessed by clinical records.

The safety/ tolerability of standard of care treatment as assessed by reported adverse events from participants in Arm B. Adverse Events will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) v.5.

The median circulating tumor DNA (ctDNA) progression free survival, which will be defined as the time from randomization to first documented disease progression, positive ctDNA detection, or death as assessed by the radiology team in participants with undetectable ctDNA. ctDNA levels in participants will be tested/assessed using liquid biopsies.

The effect of interventions on circulating tumor DNA (ctDNA) levels in participants who receive aggressive interventions (Arm A) versus standard of care treatments (Arm B). The effect of interventions on ctDNA will be assessed based on recorded ctDNA levels measured using liquid biopsies at baseline and after treatment.

University of Chicago

Gastrointestinal Diseases

Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid.

Distension and marking of the bowel lumen will be compared between the 1st and 2nd scan. Ability to see IV contrast enhancement will be assessed on the 3rd scan in relationship to the 2nd scan.

NX9 Oral Contrast Agent

Michael Davis, MD

This study will evaluate marking and distention of the bowel of the oral contrast agent, NX9, at CT of the abdomen and pelvis, VLDCT with no contrast will be followed by VLDCT with NX9 contrast followed by CT with NX9 and standard IV contrast. Eligible subjects will have cancer or other GI disorders for which CT is typically used to assess their disease. This is an open label study with efficacy evaluated in a masked fashion following completion of the entire study. Results of the NX9 scans will not be used for treatment decisions. PK will be evaluated in a subset of subjects at a single center.

Phase 2 Study of NX9 for Delineation of Bowel Anatomy

APhase 2 Open Label, Study to Evaluate Safety, Pharmacokinetics & Efficacy of Oral Contrast Agent, NX9 for Delineation of Bowel Anatomy at CT Imaging With/Without IV Contrast in Subjects With Cancer or GI Disease Typically Evaluated With CT

IPD that supports publications and presentations.

Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Readers will assess the Stomach, duodenum, jejunum, ileum, terminal ileum, proximal colon, and distal colon to record the bowel distension as the diameter of the bowel measured as mm distance from inner wall to inner wall, and the marking of bowel as the fraction of bowel length marked by NX9 contrast agent rated on a 5 point scale from 0=none, 1=0 to \<25%, 2=25 to \<50%, 3=50 to \<75%, and 4=75 to 100% the length of the bowel.

Changes from pre-dose physical exam will be assessed by the PI and recorded as an adverse event, either related or not related to study drug. Additionally, subjects will be queried as to how they are feeling immediately following administration of study drug through 4 hours post-administration, on their Day 3 visit and during the Day 14 phone call. All symptoms will be evaluated by the PI and recorded as adverse events as appropriate. For example, if there are symptoms that are not in keeping with their pre-dose medical history.

An abnormal laboratory result or a change from baseline will be considered an AE if it induces clinical signs or symptoms, if the abnormality is of a degree that requires active management (e.g. discontinuation of the study drug, dose modification) or when the event is requiring treatment or other therapeutic intervention (e.g. iron supplements, blood transfusion, etc.). The following parameters will be evaluated: Hematology (Hgb, RBC, WBC, Platelets, HCT), Chemistry (BUN, Creatinine, ALT, AST, GGT, LDH, AlkPhos, Total Bilirubin, Glucose, Albumin, Total Protein, Sodium, Calcium, Potassium, Phosphate, Chloride, Bicarbonate, Urate, Total Cholesterol), Urinalysis (pH, Specific gravity, Glucose, Protein, Ketones, Bilirubin, Blood, Nitrites, Leukocytes, Urobilinogen). Analysis will look for trends in clinical laboratory abnormalities.

Standard 12-lead ECGs will be taken on the Day of dosing approximately 1 hour prior to dosing and at 4 hours post-dose and on the Day 3 follow up visit. The following parameters will be recorded (Ventricular rate in bpm, PR interval, RR interval, QRS interval, QT interval, QTcF and overall reading. Any clinically significant findings and changes will be investigated by the PI and reported as AEs if appropriate.

Serum samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.

Urine samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.

Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Scored on 4-point scale where 0=Cannot determine presence or absence of IV contrast enhancement of bowel wall for any of the oral contrast-filled bowel,1=IV contrast enhancement of bowel wall is clearly assessed for less than half of the oral contrast-filled bowel, 2=IV contrast enhancement of bowel wall is clearly assessed for most of the oral contrast-filled bowel, and 3=IV contrast enhancement of bowel wall is clearly assessed for all of the oral contrast-filled bowel

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	NCT04931420	Metastatic Canc... Foregut Carcino... Gastric Adenoca... Gallbladder Ade... Liver Cancer GI Cancer GI Carcinoma Lung Cancer	Standard of Car... Video-Assisted ... Lobectomy Consolidative R... Ablation Treatm... Resection or Ex... Peritonectomy Transarterial R...	18 Years -	University of Chicago
Phase 2 Study of NX9 for Delineation of Bowel Anatomy	NCT04789200	GI Carcinoma GI Disorders	NX9 Oral Contra...	18 Years - 85 Years	Nextrast, Inc.

Spots Global Cancer Trial Database for gi carcinoma

Every month we try and update this database with for gi carcinoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.