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Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study

3. desember 2021 oppdatert av: Junjie Peng, Fudan University
For patients with stage III colon cancers, radical resection of primary tumor followed by adjuvant chemotherapy is currently the standard treatment. Adjuvant chemotherapy with 5-fluorouracil and oxaliplatin based regimen has been proved effective to improve recurrence-free survival and overall survival. Approximately half of patients with stage III colon cancers can be cured by surgery alone, while a substantial number of patients still experience recurrence, even with standard adjuvant chemotherapy. In recent years, circulating tumor DNA (ctDNA) has been detected in the cell-free component of peripheral blood samples in advanced colorectal cancers and many other solid tumors. Several previous studies have suggested that in patients with stage I-III colorectal cancer, postoperative ctDNA was an valuable biomarker to predict minimal residual disease (MRD) after radical resection, thus redefining patients risk outcome groups and guiding postoperative treatment. In addition, recent studies based on serial postoperative ctDNA detection showed that serial ctDNA analyses revealed disease recurrence up to 5-16.5 months ahead of radiological imaging. Here, based on the role of ctDNA in predicting MRD, we conducted an open, prospective, randomized controlled phase II cohort study to explore if ctDNA can as a biomarker to guide personalized surveillance strategy after surgery.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

316

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200032
        • Rekruttering
        • Fudan University Shanghai Cancer Center
        • Ta kontakt med:
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Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 and ≤80 years old, regardless of gender;
  • Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 ~ 2;
  • Pathologically confirmed as stage III colorectal cancer;
  • Radical operation performed ;
  • With expected survival of more than 12 months;
  • The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.

Exclusion Criteria:

  • Neoadjuvant therapy performed before operation;
  • Blood transfusion performed during operation or within 2 weeks before operation;
  • Incomplete baseline samples, including preoperative plasma samples, surgical tumor tissue samples and plasma samples 3-7 days after operation;
  • Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point
  • Pregnant or lactating women who have fertility and do not take adequate contraceptive measures;
  • Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer;
  • Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms;
  • Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency;
  • Significant impairment of important organ function;
  • Other conditions in which the investigator believes that the patient should not participate in this trial.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: ctDNA dynamic monitoring + routine postoperative follow-up

ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total. At the same time, routine postoperative follow-up is given.

To be pointed out, after the completion of the adjuvant chemotherapy, if the ctDNA test indicates positive, patients will immediately perform chest, abdominal and pelvic CT and other imaging tests to determine whether there is recurrence /metastasis. If it is not confirmed, repeat the imaging review every two months, and continue to perform ctDNA test every three months. If the following ctDNA test is negative for two consecutive times, the above imaging reexamination will return to the routine follow-up frequency. In addition, during the follow-up, the following situations may occur: the imaging examination has found recurrence/metastasis, but the ctDNA test is still negative. At this time, the patient will be informed and treated in time of the recurrence/metastasis.
Diagnostisk test: ctDNA dynamic monitoring
ctDNA is detected before operation, before chemotherapy, and then every three months for 2 years, 10 times in total.
Ingen inngripen: routine postoperative follow-up
Only routine postoperative follow-up is given as follows: Physical examination and CEA were performed every 3-6 months for the first 2 years, every 6 months within the third to fifth year, and then annually. Chest/abdominal/pelvis computed tomography was performed annually for up to 5 years, and colonoscopy was performed for proper patients the first year after treatment and repeated in the third year if no advanced adenoma was found and then every 5 years.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sensitivity of postoperative ctDNA in monitoring recurrence and metastasis
Tidsramme: Up to 60 months.
Number of patients with ctDNA positive and imaging confirmed recurrence or metastasis / number of all imaging confirmed recurrence or metastasis
Up to 60 months.
Specificity of postoperative ctDNA in monitoring recurrence and metastasis
Tidsramme: Up to 60 months.
Number of patients with ctDNA negative and no recurrence and metastasis confirmed by imaging / number of patients with no recurrence and metastasis confirmed by imaging
Up to 60 months.
Accuracy of postoperative ctDNA in monitoring recurrence and metastasis
Tidsramme: Up to 60 months.
True positive+True negative/sample size
Up to 60 months.
Secondary resection rate
Tidsramme: Up to 60 months.
The rate of R0 resection for recurrence or metastasis after surgery of the primary
Up to 60 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ctDNA-disease free survival (DFS)
Tidsramme: Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
Disease free survival time under ctDNA monitoring
Under ctDNA monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
CT-DFS
Tidsramme: Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
Disease free survival time under imaging monitoring
Under imaging monitoring, from date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.
△DFS
Tidsramme: Up to 60 months.
The difference between ctDNA-DFS and CT-DFS
Up to 60 months.
total overlevelse (OS)
Tidsramme: Fra dato for randomisering til dato for første dokumenterte dødsdato uansett årsak, vurdert opp til 60 måneder.
Samlet overlevelse av inkluderte pasienter
Fra dato for randomisering til dato for første dokumenterte dødsdato uansett årsak, vurdert opp til 60 måneder.
ctDNA clearance rate
Tidsramme: Up to 60 months.
The rate of ctDNA positive before chemotherapy that turns negative after adjuvant chemotherapy
Up to 60 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2021

Primær fullføring (Forventet)

1. september 2022

Studiet fullført (Forventet)

1. september 2024

Datoer for studieregistrering

Først innsendt

21. november 2021

Først innsendt som oppfylte QC-kriteriene

3. desember 2021

Først lagt ut (Faktiske)

17. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. desember 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. desember 2021

Sist bekreftet

1. desember 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ctDNA- phaseIIICRC

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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