Appendiceal AdenocarcinomaNCT05947838
A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
A study testing Circulating tumoral DNA directed neoadjuvant therapy arm in people with Appendiceal Adenocarcinoma and Colorectal, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendiceal Adenocarcinoma, Colorectal
- What is being tested?
- Circulating tumoral DNA directed neoadjuvant therapy arm
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Michael White, MD, 713-355-0897, mgwhite@mdanderson.org
Michael White, MD
About this study
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.
Read the detailed description
Primary Objectives:
- The primary aim of this prospective study is to assess and compare the recurrence-free survival following CRS and HIPEC of carcinomatosis of colorectal or appendiceal origin with curative intent among ctDNA-negative and ctDNA-positive patients based on their ctDNA status immediately prior to CRS and HIPEC
Secondary Objectives:
- To assess 1 and 2-year recurrence-free survival following CRS and HIPEC with curative intent among ctDNA-negative and ctDNA-positive patients
- To assess and compare 2-year overall survival following CRS and HIPEC among ctDNA-negative and ctDNA-positive patients
- To assess the duration of response, including duration of overall response, duration of overall CR and duration of stable disease
- To evaluate the proportion of ctDNA-negative patients at 1-year post-resection
- To compare survival rate of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls
- To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement
- To delineate the pattern of disease recurrence
- To assess ctDNA sensitivity and specificity for predicting disease recurrence
- To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection
- To evaluate and correlate cross-sectional imaging characteristics of tumors with biologic factors such as pathologic response, ctDNA detection, and recurrence free survival
- Conditions
- Appendiceal Adenocarcinoma, Colorectal
- Being tested
- Circulating tumoral DNA directed neoadjuvant therapy arm
- Medical subject headings
- Adenocarcinoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumoral DNA directed neoadjuvant therapy armProcedure or surgery
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Circulating tumoral DNA directed neoadjuvant therapy arm | Experimental | Participants will have their circulating tumoral DNA levels measured at the onset of neoadjuvant chemotherapy and during their neoadjuvant treatment to direct the duration of therapy provided. Receives: Procedure: Circulating tumoral DNA directed neoadjuvant therapy arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start4 Dec 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendiceal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael White, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947838
- Sponsor's protocol ID
- 2023-0214
- Other IDs
- NCI-2023-05381
- Status last verified
- May 2026
- First submitted
- 7 Jul 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05947838
- Acronym / sponsor ID
- 2023-0214
- Conditions
- Appendiceal Adenocarcinoma, Colorectal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
- The primary aim of this prospective study is to assess and compare the recurrence-free survival following CRS and HIPEC of carcinomatosis of colorectal or appendiceal origin with curative intent among ctDNA-negative and ctDNA-positive patients based on their ctDNA status immediately prior to CRS and HIPEC
Secondary Objectives:
- To assess 1 and 2-year recurrence-free survival following CRS and HIPEC with curative intent among ctDNA-negative and ctDNA-positive patients
- To assess and compare 2-year overall survival following CRS and HIPEC among ctDNA-negative and ctDNA-positive patients
- To assess the duration of response, including duration of overall response, duration of overall CR and duration of stable disease
- To evaluate the proportion of ctDNA-negative patients at 1-year post-resection
- To compare survival rate of ctDNA-negative patients undergoing ctDNA-guided postoperative chemotherapy to historical controls
- To evaluate proportion of patients in each arm who change chemotherapy in response to ctDNA measurement
- To delineate the pattern of disease recurrence
- To assess ctDNA sensitivity and specificity for predicting disease recurrence
- To evaluate and correlate patient molecular subtypes and characterization of tumor biologic factors that are associated with ctDNA detection
- To evaluate and correlate cross-sectional imaging characteristics of tumors with biologic factors such as pathologic response, ctDNA detection, and recurrence free survival
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulating tumoral DNA directed neoadjuvant therapy arm | Experimental | Procedure: Circulating tumoral DNA directed neoadjuvant therapy armParticipants will have their circulating tumoral DNA levels measured at the onset of neoadjuvant chemotherapy and during their neoadjuvant treatment to direct the duration of therapy provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumoral DNA directed neoadjuvant therapy armGiven by IV (vein) | Procedure or surgery | Circulating tumoral DNA directed neoadjuvant therapy arm |
Primary outcome
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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TLR9 Immunotherapy for Peritoneal Carcinomatosis
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Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
Esophageal Carcinoma, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)
Phase II, Ivonescimab
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael White, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating tumoral DNA directed neoadjuvant therapy arm in people with Appendiceal Adenocarcinoma and Colorectal, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael White, MD ((713) 355-0897, mgwhite@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.