Is NCT05947838 recruiting in Houston, TX?

Yes, NCT05947838 is currently recruiting participants at its Houston, TX location. This appendiceal adenocarcinoma clinical trial is actively enrolling qualified participants.

How do I join the appendiceal 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.

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.

Appendiceal Adenocarcinoma Clinical Trial in Houston, TX

About This Appendiceal Adenocarcinoma Study in Houston

To learn if circulating tumor DNA (ctDNA) testing before cytoreductive surgery (CRS) with or without heated intraperitoneal chemotherapy (HIPEC) can show if patients have a low or high risk of the disease returning and help doctors decide if less or more intense chemotherapy is needed as treatment before surgery. ctDNA testing measures the amount of tumor DNA (genetic information) in the blood.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Histologically/cytologically confirmed diagnosis of moderate or poorly differentiated appendiceal or colorectal adenocarcinoma of any grade with Initial resectable disease.

Have metastatic peritoneal disease that is visible on imaging or at the time of laparoscopy.

Age ≥18 years. Because no adverse event data are currently available on the use of ctDNA in chemotherapy decision making in patients \<18 years of age, children are excluded from this study.

ECOG performance status ≤1 (Karnofsky ≥70%,).

Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin 1.5x ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN Creatinine clearance ≥30 mL/min

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Patients with treated brain metastases are not eligible.

Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

Estimated life-expectancy of \> 4 months.

The effects of standard chemotherapeutic agents used in this trial (5-fluouracil, oxaliplatin, leucovorin, and irinotecan) on the developing human fetus are detrimental. For this reason and because these agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable

Exclusion Criteria

ary factor which may be one of the following:

Postmenopausal (no menses in greater than or equal to 12 consecutive months).

History of hysterectomy or bilateral salpingo-oophorectomy.

Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).

History of bilateral tubal ligation or another surgical sterilization procedure.

Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of their chemotherapy administration.

Ability to understand and the willingness to sign a written informed consent document.

English and Non-English-speaking. Exclusion Criteria:

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.

Patients who are receiving any other investigational agents.

Patients with brain or other visceral (i.e. liver and/or lung) metastases at the discretion of the investigator.

Patients with uncontrolled intercurrent illness (Indicate clearly what type or extent)

Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because chemotherapeutic agents used carry the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy. These potential risks may also apply to other agents used in this study.

If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.

Serious adverse chemotherapy related adverse events (grade 3 or 4) that were symptomatic and required prolong chemotherapy break (\>6weeks).

Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the study subject's best interest to participate, in the opinion of the treating investigator.

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 (NCT05947838) 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.

Appendiceal Adenocarcinoma Treatment Options in Houston, TX

If you're searching for appendiceal adenocarcinoma treatment options in Houston, TX, this clinical trial (NCT05947838) 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 appendiceal 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 appendiceal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Appendiceal Adenocarcinoma Clinical Trial in Houston, TX

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