NCT05529615

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,684

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2022May 2029

First Submitted

Initial submission to the registry

August 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

6.5 years

First QC Date

August 25, 2022

Last Update Submit

September 6, 2022

Conditions

Colon CancerCirculating Tumor DNA

Keywords

chemotherapyctDNAcolon cancerprognosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 year

Study Arms (2)

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

OTHER

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.

Procedure: detection of ctDNA

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

OTHER

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.

Procedure: detection of ctDNA

Interventions

detection of ctDNAPROCEDURE

the ctDNA will be detected during the treatment and served as the andomization basis

stage II with high risk and stage III with low risk（T1-3N1）stage III with high risk（T4 or N2 or both）

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university cancer hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Aiwen Wu, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengju Chen, M.D.

CONTACT

+8601088196086pengjuchen@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI cancer III

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 7, 2022

Study Start

November 1, 2022

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations

CN(1)