Prevention of recurrent disease by additional chemotherapy in patients with detectable circulating tumor DNA in the blood after surgery for stage II (lymph nodes unaffected) colon cancer.

Effectiveness of adjuvant chemotherapy in preventing recurrence in stage II colon cancer patients with detectable circulating tumor DNA: a cohort multiple randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25151

Enrollment

1320

Registered

2017-05-18

Start date

2018-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II colon cancer, adjuvant chemotherapy, circulating tumor DNA

Interventions

Adjuvant chemotherapy 6 months CAPOX or FOLFOX

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inclusion in PLCRC cohort study, informed consent for repeated blood withdrawals and invitation for future researh 2. Inclusion in observational substudy PLCRC-MEDOCC 3. Histological confirmation of stage II colon cancer 4. Fit for combination chemotherapy

Exclusion criteria

Exclusion criteria: 1. Incomplete resection (R1 or R2 resection) 2. Other malignancy in previous 5 years (except for skin cancer other than melanoma and carcinoma in situ) 3. Indication for ACT according to treating physician 4. Contra-indication for systemic treatment with fluoropyrimidines and oxaliplatin

Design outcomes

Primary

Measure	Time frame
Recurrence Rate (RR) 2 years after surgery	—

Secondary

Measure	Time frame
- 5-year Recurrence Rate - 5 and 7-year overall survival (OS) - quality of life (QoL) - cost-effectiveness analysis	—

Contacts

Public ContactK.L. van Rooijen

Kamer Q04.4.21, UMC Utrecht

info@plcrc.nl06-46919566

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)