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Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer (CTAC)

Primary Purpose

Colon Cancer, Circulating Tumor DNA

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
detection of ctDNA
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring chemotherapy, ctDNA, colon cancer, prognosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 18 to 75
  2. Colon adenocarcinoma confirmed by pathology (including high and high differentiated tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma)

  3. Postoperative pathology is stage II with high-risk factors or stage III;

    High risk stage II refers to stage II colon cancer with at least one of the following:

    a) T4 stage; b) The number of lymph nodes detected was less than 12; c) Poor differentiation (except MSI-H); d) Complicated with LVI or PNI；e) Complicated with obstruction or perforation.

  4. No distant metastasis was found in preoperative imaging examination and operation;
  5. ECOG score: 0-2 points;
  6. MSS/pMMR and BRAF wild type
  7. Start time of chemotherapy is less than 2 months from the operation
  8. Have sufficient organ functions;

  9. The baseline blood routine and biochemical indexes of the subject meet the following standards:

    • hemoglobin ≥ 9.0 g / dl;
    • absolute neutrophil count (ANC) ≥ 1500 / mm3;
    • platelet count ≥ 100000 / mm3;
    • total bilirubin ≤ 1.5 times the upper limit of normal value (ULN);
    • glutamic pyruvic transaminase and glutamic oxalic transaminase ≤ 2.5 times ULN;
    • creatinine ≤ 1.5 times ULN;
  10. Patients or family members who can understand the study protocol and are willing to participate in the study shall provide written informed consent.

Exclusion Criteria:

  1. Receive chemotherapy, radiotherapy or immunotherapy before operation
  2. History of malignant tumor in the past 5 years (except fully cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial cell skin cancer)
  3. Pregnant women
  4. Serious mental illness
  5. Those with poor physical condition and difficult to complete chemotherapy
  6. Patients or family members cannot understand the conditions and objectives of this study

Sites / Locations

  • Peking university cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

stage II with high risk and stage III with low risk（T1-3N1）

stage III with high risk（T4 or N2 or both）

Arm Description

ctDNA will be detected at 7 days after surgical treatment. If，ctDNA(-)-> observation； ctDNA(+)-> 1:1 randomized as Capeox chemotherapy 3 months and observation. CtDNA will be detected at 4 months after surgical treatment.

ctDNA will be detected at 7 days after surgical treatment. All the stage III with high risk will receive Capeox chemotherapy 3 months. ctDNA will be detected after the completion of Capeox chemotherapy 3 months. If，ctDNA(-) -> observation； ctDNA(+) -> 1:2 randomized as Capeox chemotherapy 3 monthsand second line treatment（decided by physician）. CtDNA will be detected at 7 months after surgical treatment.

Outcomes

Primary Outcome Measures

3-year disease-free survival rate
Whether the 3-year DFS of ctDNA negative colon cancer patients in the low-risk group is not inferior to adjuvant chemotherapy; 2) Whether second-line chemotherapy can significantly improve the 3-year DFS of ctDNA positive colon cancer patients in the high-risk group compared with standard chemotherapy.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2022
Last Updated
September 6, 2022
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05529615
Brief Title
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer
Acronym
CTAC
Official Title
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer: A Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2029 (Anticipated)
Study Completion Date
May 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The IDEA study classified stage III colon cancer into low-risk (T1-3/N1) and high-risk patients (T4 or N2) according to TNM stage. The results showed that for some low-risk patients, chemotherapy could be reduced without survival loss. In recent years, circulating tumor DNA had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. Postoperative ctDNA is also considered as a marker of increased risk of recurrence for stage I-III colon cancer and can provide predictive information for decision making on adjuvant treatment. The results of GERCOR-PRODIGE, concomitant study of IDEA-FRANCE, showed that in the high-risk group, the patients with ctDNA positive and receiving adjuvant chemotherapy for 6 months had similar prognosis as the patients with ctDNA negative and receiving chemotherapy for 3 months; in the low-risk group, the patients with ctDNA positive but receiving chemotherapy for 3 months had worst prognosis, and the prognosis of patients with ctDNA negative chemotherapy for 3 months and 6 months and ctDNA positive chemotherapy for 6 months were similar. This indicates that risk stratification can be further performed according to the results of ctDNA after clinical pathological staging. Pathological staging is still an important decision-making factor for chemotherapy. It is not reliable to the chemotherapy decision making just based on ctDNA and abandoning clinical staging. Therefore, a prospective, multicenter, open-label, randomized controlled clinical trial was designed aimed to investigate circulating tumor DNA guided adjuvant chemotherapy for colon cancer. In this study, all the patients are divided into high-risk group and low-risk group according to the postoperative pathology. Patients in each group were randomized to different treatment schedule according to the results of ctDNA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Circulating Tumor DNA
Keywords
chemotherapy, ctDNA, colon cancer, prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2684 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stage II with high risk and stage III with low risk（T1-3N1）
Arm Type
Other
Arm Description
ctDNA will be detected at 7 days after surgical treatment. If，ctDNA(-)-> observation； ctDNA(+)-> 1:1 randomized as Capeox chemotherapy 3 months and observation. CtDNA will be detected at 4 months after surgical treatment.
Arm Title
stage III with high risk（T4 or N2 or both）
Arm Type
Other
Arm Description
ctDNA will be detected at 7 days after surgical treatment. All the stage III with high risk will receive Capeox chemotherapy 3 months. ctDNA will be detected after the completion of Capeox chemotherapy 3 months. If，ctDNA(-) -> observation； ctDNA(+) -> 1:2 randomized as Capeox chemotherapy 3 monthsand second line treatment（decided by physician）. CtDNA will be detected at 7 months after surgical treatment.
Intervention Type
Procedure
Intervention Name(s)
detection of ctDNA
Intervention Description
the ctDNA will be detected during the treatment and served as the andomization basis
Primary Outcome Measure Information:
Title
3-year disease-free survival rate
Description
Whether the 3-year DFS of ctDNA negative colon cancer patients in the low-risk group is not inferior to adjuvant chemotherapy; 2) Whether second-line chemotherapy can significantly improve the 3-year DFS of ctDNA positive colon cancer patients in the high-risk group compared with standard chemotherapy.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18 to 75 Colon adenocarcinoma confirmed by pathology (including high and high differentiated tubular adenocarcinoma, papillary adenocarcinoma, low differentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma) Postoperative pathology is stage II with high-risk factors or stage III; High risk stage II refers to stage II colon cancer with at least one of the following: a) T4 stage; b) The number of lymph nodes detected was less than 12; c) Poor differentiation (except MSI-H); d) Complicated with LVI or PNI；e) Complicated with obstruction or perforation. No distant metastasis was found in preoperative imaging examination and operation; ECOG score: 0-2 points; MSS/pMMR and BRAF wild type Start time of chemotherapy is less than 2 months from the operation Have sufficient organ functions; The baseline blood routine and biochemical indexes of the subject meet the following standards: hemoglobin ≥ 9.0 g / dl; absolute neutrophil count (ANC) ≥ 1500 / mm3; platelet count ≥ 100000 / mm3; total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); glutamic pyruvic transaminase and glutamic oxalic transaminase ≤ 2.5 times ULN; creatinine ≤ 1.5 times ULN; Patients or family members who can understand the study protocol and are willing to participate in the study shall provide written informed consent. Exclusion Criteria: Receive chemotherapy, radiotherapy or immunotherapy before operation History of malignant tumor in the past 5 years (except fully cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial cell skin cancer) Pregnant women Serious mental illness Those with poor physical condition and difficult to complete chemotherapy Patients or family members cannot understand the conditions and objectives of this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pengju Chen, M.D.
Phone
+8601088196086
Email
pengjuchen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking university cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengju Chen, M.D.
Phone
+8601088196086
Email
pengjuchen@163.com

12. IPD Sharing Statement

Learn more about this trial

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer

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