Klinische Studien

CIRCULATE (AIO-KRK-0217)

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
TUD-CIRC01-0712018-003691-12

Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation

Status: Active

Purpose / Objectives

Primary Outcome

  • The primary aim of the CIRCULATE study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.

 

Secondary Outcomes

  • to compare the overall survival in colon cancer patients stage II in ctDNA positive pa-tients with and without capecitabine
  • to determine the disease free survival in ctDNA negative patients
  • to determine the overall survival of ctDNA negative patients
  • to compare the disease free and overall survival in patients without adjuvant therapy with capecitabine according to their ctDNA Status
  • to compare the site of metastases according to the way of metastases (heamato- vs lymphogenic vs. local/peritoneal) and ctDNA Status
  • to determine the capecitabine safety.

 

Diagnosis

Target population

Stage

II

Age

18-99

Inclusion criteria

  • Resected colon cancer stage II, OR Resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum ), so that the treatment follows the recommenda-tions for colon cancer. Patients, in whom the tumour stage is not yet know, can be en-rolled into the screening. 
  • Patients with known microsatellite instability (MSI-H) or mis-match repair deficiency (dMMR)
  • Known clinical high risk situation if it is regarded as certain in-dication for an adjuvant chemotherapy
  • Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbid-ity, active second cancer or age) It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemo-therapy.
  • Patients, in whom the randomisation or chemotherapy is un-feasible due to logistic reasons (travel distance, compliance)
  • [...]

Exclusion criteria

  • Patients with microsatellite instability (MSI-H) or mismatch re-pair deficiency (dMMR)
  • Known clinical high risk situation if it is regarded as certain in-dication for an adjuvant chemotherapy
  • R1- or R2- status, or unknown R- status (Rx)
  • Number of investigated lymph nodes < 10
  • WHO performance status ≥ 2
  • Colon or rectal cancer with UICC stage III or IV
  • [...]

Study design

  • Phase IV
  • Multicenter
  • Prospective
  • Randomized
  • Three-arm
  • Open Label

Intervention

Experimental intervention: Capecitabine in ctDNApos patients (additional oxaliplatin allowed) and follow-up within the trial

  • Standard intervention: Follow-up (no chemotherapy)
  • Follow-up per patient: 5 years
  • Duration of intervention per patient: 6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine

 

Documents (password protected)

Responsibilities in overall study

Ethikkommission der Medizinischen Fakultät "Carl Gustav Carus" der Technischen Universität Dresden

National Coordinating Investigator

PD Dr. Gunnar Folprecht

Study Sites

Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg

Address
Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
90419 Nürnberg
Haus: Bau 12

Status

Active

 
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