Is NCT04615013 recruiting in Houston, TX?

Yes, NCT04615013 is currently recruiting participants at its Houston, TX location. This cervical esophagus adenocarcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cervical Esophagus Adenocarcinoma Clinical Trial in Houston, TX

Q: How do I join the cervical esophagus adenocarcinoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Cervical Esophagus Adenocarcinoma Study in Houston

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction

Adenocarcinoma of the esophagus stages II-III allowed

Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:

Oxaliplatin and fluorouracil (5-FU) or capecitabine

Docetaxel and/or 5-FU or paclitaxel

Carboplatin and paclitaxel

Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician

Patients with lesions for which the EUS scope is not able to traverse the tumor are allowed on this trial as long as an injection can be performed as per treating physician's discretion

Has at least 1 and up to 4 target lesion(s) in the esophagus that are measurable on cross sectional imaging and repeated measurements (via Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) at the same anatomical location should be achievable

Local nodal disease around the esophagus allowed

Nodal target lesions must be \>= 15 mm (short axis) based on computed tomography (CT) (slice thickness of 5 mm or less) or magnetic resonance imaging (MRI)

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Hemoglobin \>= 8.0 g/dL

Absolute neutrophil count (ANC) \>= 1,500/mm\^3

Platelet count \>= 100,000/mm\^3

Creatinine =\< 1.5 x upper limit of normal (ULN)

Calculated (Calc.) creatinine clearance \> 30 mL/min

Glomerular filtration ratio \> 40 mL/min per 1.73 m\^2

Total bilirubin =\< 2.0 mg/dL

Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

Negative urine or serum pregnancy test =\< 7 days of NBTXR3 injection in all female participants of child-bearing potential

Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria

Prior radiation or any therapy for the treatment of esophageal cancer

Prior surgical resection of esophageal tumor

Esophageal cancer with radiographic evidence of metastases at screening

At screening, past medical history of:

Esophageal fistula

Tracheoesophageal fistula

Siewert type III tumors

Evidence of bulky disease and/or abutment of tumor above the carina that may result in tracheoesophageal fistulas as determined by the investigator or treating physician

Tumors above the carina without defacement of the fat plane between tumor and the airway are allowed

Known uncontrolled (grade \>= 2) or active esophageal or gastric ulcer disease within 28 days of enrollment

Known contraindication to iodine-based or gadolinium-based intravenous (IV) contrast

Active malignancy, in addition to esophageal cancer except for basal cell carcinoma of the skin or non-metastatic low risk prostate cancer definitively treated and relapse free within at least 3 months from time of screening

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment

Known active, uncontrolled (high viral load) human immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection

Female patients who are pregnant or breastfeeding

Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly

Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT04615013) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cervical Esophagus Adenocarcinoma Treatment Options in Houston, TX

If you're searching for cervical esophagus adenocarcinoma treatment options in Houston, TX, this clinical trial (NCT04615013) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cervical esophagus adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cervical esophagus adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Cervical Esophagus Adenocarcinoma Clinical Trial in Houston, TX

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