A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether tumor DNA in the blood can help doctors choose how much chemotherapy to give before surgery. It is for adults with cancer of the colon, rectum, or appendix that has spread to the lining of the belly and can be removed by surgery. The blood test may also help show the risk of cancer coming back after surgery, with or without heated chemotherapy in the belly.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 or older, with adenocarcinoma confirmed by a tissue or cell test. This is a cancer that starts in gland cells. The study lists rules about how abnormal the cancer cells look.
- Have cancer that can be removed by surgery and has spread to the belly lining, seen on a scan or during surgery using a small camera.
- Be able to do most daily activities and be expected to live more than 4 months.
- Have blood counts and liver and kidney test results that meet study limits. If you have heart problems or past treatment that can harm the heart, meet the study’s heart health rules.
- If you have hepatitis B, treatment must keep the virus below levels tests can detect. Hepatitis C must be cured or undetectable during treatment. If you have HIV, treatment must be working, with no detectable virus within 6 months.
- A past or current second cancer is allowed if it will not affect study safety or results.
- Agree to use approved birth control before and during the study if required. Men must also use it for 4 months after chemotherapy ends. Not having sex is also an option.
- Be able to understand the study and sign a consent form. You do not need to speak English.
Who can't join
- Still have side effects from past cancer treatment that are more than mild, except hair loss.
- Be taking another experimental treatment.
- Have cancer that has spread to the brain, including treated brain tumors. Spread to other organs, such as the liver or lungs, may also rule you out based on the study doctor’s decision.
- Have an uncontrolled illness, or mental health or social problems that would keep you from following study requirements.
- Be pregnant. Breastfeeding must stop if you receive chemotherapy.
- Have had major surgery in the past 4 weeks and not recovered enough from its side effects or problems before study treatment starts.
- Have had severe chemotherapy side effects that caused symptoms and required a treatment break longer than 6 weeks.
- Have another condition, treatment, or test result that the doctor believes could affect study results, prevent full participation, or make joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 exclusionary 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.
Study sites (1)
TX
- M D Anderson Cancer Center · Houston, TX 77030Michael White, MD · Study contact · 713-355-0897 · mgwhite@mdanderson.orgMichael White, MD · Principal investigatorMore trials in Houston