A Prospective Feasibility Study Using ctDNA to Tailor Neoadjuvant Chemotherapy for Patients With Colorectal or Appendiceal Adenocarcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%,).

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Circulating tumoral DNA directed neoadjuvant therapy arm

    Procedure/Surgery

    Given by IV (vein)

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Circulating tumoral DNA directed neoadjuvant therapy armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

). 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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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