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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.


- candidate number27252
- NTR NumberNTR6455
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2017
- Secondary IDsNone 
- Public TitlePrevention 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.
- Scientific TitleEffectiveness of adjuvant chemotherapy in preventing recurrence in stage II colon cancer patients with detectable circulating tumor DNA: a cohort multiple randomized controlled trial.
- ACRONYM
- hypothesisAdjuvant chemotherapy in stage II CC patients with detectable postoperative ctDNA will lead to a 30% lower risk of disease recurrence within two years compared to standard treatment (regular follow-up).
- Healt Condition(s) or Problem(s) studiedChemotherapy, Colon cancer, DNA, Tumour
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2022
- Target number of participants1320
- InterventionsAdjuvant chemotherapy 6 months CAPOX or FOLFOX
- Primary outcomeRecurrence Rate (RR) 2 years after surgery
- Secondary outcome- 5-year Recurrence Rate
- 5 and 7-year overall survival (OS)
- quality of life (QoL)
- cost-effectiveness analysis
- Timepoints- Enrollment in PLCRC and observational PLCRC-MEDOCC study before surgery
Obtaining IC, blood withdrawal 1-3 weeks after surgery, ctDNA analysis
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs. K.L. van Rooijen
- CONTACT for SCIENTIFIC QUERIESProf. dr. M. Koopman
- Sponsor/Initiator Dutch Colorectal Cancer Group (DCCG)
- Funding
(Source(s) of Monetary or Material Support)
StandUpToCancer (SU2C)
- Publications
- Brief summaryBackground and rationale
Patients with stage II CC have a good chance of survival, however, 15-20% of patients with stage II CC experience recurrence of disease. Only patients with clinicopathological high-risk factors (T4 tumor as most important factor) are offered ACT.
In stage II CC solid support and consensus is lacking regarding effectiveness of ACT.
Recently, ctDNA was shown to have a strong association with disease recurrence in stage II CC. In >80% of patients with detectable ctDNA after surgery disease recurrence occurred within 2 years. Whether ACT can reduce the RR in patients with detectable ctDNA is not known, and therefore we propose a cohort multiple Randomized Controlled Trial (cmRCT) to evaluate effectiveness of ACT in stage II CC patients with detectable ctDNA after surgery. Methods Stage II CC patients, included in the Prospective Dutch CRC cohort (PLCRC) and not considered for ACT by the treating physician, will be randomized 1:1 according to the cmRCT design. In patients randomized to the intervention arm, ctDNA results will be determined immediately after surgery. Patients with detectable ctDNA will be offered ACT (CAPOX/FOLFOX). In the control group, ctDNA will be analyzed batch-wise at the end of the trial and results will not be used in patient care. Patients in this arm will not receive ACT according to standard clinical care.
- Main changes (audit trail)
- RECORD18-mei-2017 - 1-jul-2017


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