Study Comparing Standard of Care Therapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
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|ClinicalTrials.gov Identifier: NCT04931420|
Recruitment Status : Not yet recruiting
First Posted : June 18, 2021
Last Update Posted : June 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Foregut Carcinoid Tumor Gastric Adenocarcinoma Gallbladder Adenocarcinoma Liver Cancer GI Cancer GI Carcinoma Lung Cancer||Drug: Standard of Care Chemotherapy Procedure: Video-Assisted Thoracic Surgery (VATS) Procedure: Lobectomy Radiation: Consolidative Radiation Radiation: Ablation Treatment Procedure: Resection or Excision Procedure: Peritonectomy Other: Transarterial Radioembolization||Phase 2|
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 in addition to the standard of care therapy compared to the current standard of care treatment alone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||March 1, 2024|
|Estimated Study Completion Date :||September 1, 2025|
Experimental: Arm A - Participants Who Receive Sequential Procedures
All participants in this arm will receive standard of care chemotherapy based on the particular type of gastrointestinal cancer they have for three months. Afterward, based on how the participant's cancer responds to chemotherapy, the participant will receive additional sequential procedures to remove or destroy the remaining tumors present in their body.
These procedures can include surgery, radiation or ablation (a minimally invasive, needle-based treatment that uses extreme hot or cold temperatures created by radiation to kill targeted spots of cancer cells without damaging surrounding organs in the body).
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.
Drug: Standard of Care Chemotherapy
Procedure: Video-Assisted Thoracic Surgery (VATS)
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.
Other Name: thoracoscopy, thoracoscopic surgery or pleuroscopy,
If you have lung cancer, you may receive a lobectomy:
A major/invasive surgical procedure where an entire lobe of your lung is removed.
Radiation: Consolidative Radiation
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.
Other Name: intensification therapy, postremission therapy.
Radiation: Ablation Treatment
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.
Procedure: Resection or Excision
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.
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.
Other: Transarterial Radioembolization
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.
Other Name: TARE
Arm B (Control) - Participants Who Receive Standard of Care Treatment
Participants in this arm receive the current standard of care treatment 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.
Drug: Standard of Care Chemotherapy
- Median Progression Free Survival [ Time Frame: 3 months ]The median progression free survival (PFS) of participants undergoing sequential procedures (Arm A of study) vs standard of care treatment (participants in Arm B of study - aka the control group) as assessed by clinical records. Median progression free survival will be defined as the time from randomization to first documented disease progression (first measurement at clinical progression or 3 months after randomization) or death.
- 6 Month Progression Free Survival [ Time Frame: 6 months ]The percentage of participants in each arm without disease progression/death at 6 months as assessed by clinical records.
- 12 Month Progression Free Survival [ Time Frame: 12 months ]The percentage of participants in each arm without disease progression/death at 12 months as assessed by clinical records.
- Median Overall Survival [ Time Frame: 12 months ]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 [ Time Frame: 12 months ]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.
- Financial Toxicity [ Time Frame: 12 months ]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.
- Post-Procedure Morbidity of Participants in Arm A [ Time Frame: 12 months ]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.
- Post-Procedure Mortality of Participants in Arm A [ Time Frame: 12 months ]The mortality (the number of deaths) of participants after undergoing sequential cytoreductive procedures (procedures used to remove tumors) as assessed by clinical records.
- Incidence of Adverse Events Reported Among Participants in Arm B (Standard of Care Group) [ Time Frame: 12 months ]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.
- Circulating Tumor DNA (ctDNA) Progression Free survival [ Time Frame: 2 years after randomization ]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) [ Time Frame: 2 years after randomization ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931420
|Contact: Kiran Turanga, MD||773-702-6771||PhaseIICRA@medicine.bsd.uchicago.edu|
|Contact: Daniel Catenacci, MDfirstname.lastname@example.org|
|Principal Investigator:||Kiran Turanga, MD||University of Chicago|