Colon Cancer Stage IIPhase 3CIRCULATENCT04089631
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation
A Phase 3 study testing Capecitabine in people with Colon Cancer Stage II, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer Stage II
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,812 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2020to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 recommendations for colon cancer. Patients, in whom the tumour stage is not yet know, can be enrolled into the screening.
- Signed informed consent for the screening Phase
- 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 recommendations for colon cancer.
- Known microsatellite or mismatch repair status
- Confirmation, that the ctDNA result is available
- Signed second informed consent (for the randomised phase)
Who cannot join
- Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
- Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
- Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, 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 chemotherapy.
- R1- or R2-status (patients with [still] unknown R-status can be screened)
- Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
- Age < 18 years
Show all 39Show fewer
- Pregnant or breast feeding patients
- Patients with microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
- Known clinical high risk situation if it is regarded as certain indication 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
- Second cancer, except
- simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I,
- curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma
- tumours with a disease free survival of more than five years
- Contra indications for chemotherapy, especially:
- Leukocytes < 3,0 Gpt/l
- Neutrophil granulocytes < 1,5 Gpt/l
- Thrombocytes < 100 Gpt/l
- alanine aminotransferase (ALAT) or (aspartate aminotransferase) ASAT > 3x ULN
- Creatinine clearance (calculated according Cockcroft-Gault) < 30 ml/min
- Comorbidities relevantly interfering with the prognosis of the patients, i.e.:
- heart insufficiency NYHA III/IV
- relevant coronary heart disease,
- Diabetes mellitus with late sequelae
- Organ, stem cell or bone marrow transplantation
- Known hypersensitivity to capecitabine In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin
- Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start
- Known dihydropyrimidine dehydrogenase (DPD)-deficiency
- Acute infections
- Known HIV- infections, known active hepatitis B or C-infection
- Participation at another interventional study for medical treatment during the last four weeks before randomisation
- Neoadjuvant therapy before resection
- Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
- Age < 18 years
- Pregnant or breast feeding patients
- Women of childbearing potential and men with partner with childbearing potential who are not willing to take appropriate precautions to avoid pregnancy with a highly effective method in case they are randomised to "chemotherapy"
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Saxony, 01307
Gunnar Folprecht, Dr., +49 351 458 4794, gunnar.folprecht@uniklinikum-dresden.de
Gunnar Folprecht, Dr.
About this study
Official title: Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217
The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.
Read the detailed description
CIRCULATE is an investigator-initiated, multicentre, prospective, randomised, controlled trial.
Screening phase:
Patients with colon cancer (or rectal cancer, if a radiation is not indicated i.e. due to the tumour localisation) are postoperatively screened for this trial.
For this purpose, they sign an informed consent for screening. The formalin fixed paraffin embedded (FFPE) tumour block is shipped to one of the central pathological laboratories and is analysed for microsatellite instability and by panel analysis for frequent mutations in the colorectal cancer. A plasma sample is sent in parallel to the central laboratory for ctDNA. The screening is preferably performed before the patient is discharged from the surgical department and at the latest 5 weeks after resection to allow sufficient time for the analysis.
The patient- specific tumour mutations known from the panel analysis are measure in the patients plasma by ultra deep sequencing. The results of the analysis - positive for circulating tumour DNA (ctDNApos) or negative for circulating tumour DNA (ctDNAneg) - is not communicated to the patient or the investigator.
Randomised phase:
Four to eight weeks after resection, the patient presents at an investigator that is experienced with chemotherapy (i.e. Medical Oncologist) and consent for the randomised part of the study with a second informed consent form. If this baseline visit confirms that there are not contraindications to chemotherapy and if no other exclusion criteria exist, the patient is randomised:
- ctDNApos patients are randomised (2:1) in "chemotherapy" (with capecitabine) or "follow-up",
- ctDNAneg patients are randomised (1:4) in "follow-up" or "off study" which means that the follow-up will be organised within the routine clinical practice.
The result of the ctDNA will not be communicated to the patients and investigators, so that patients in the arm "follow-up" remain blinded to the ctDNA result. Due to the randomisation ratio, the prognosis of these patients is similar to those in stage II without any ctDNA analysis and differs only slightly from patients not enrolled into a clinical trial.
Patients in the arm "chemotherapy" receive adjuvant therapy with 6 months capecitabine. The investigator can decide to add oxaliplatin and to shorten the adjuvant chemotherapy to 3 months if oxaliplatin is added.
Patients in the arms "chemotherapy" and "follow-up" are followed with the same methods and time point within the study.
Patients in the arm "off study" are recommended to be follow up according to the guidelines for stage II in the routine practice.
- Conditions
- Colon Cancer Stage II
- Being tested
- Capecitabine
- Keywords
- circulating tumour DNA, ctDNA, adjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Capecitabine mono or Capecitabine/Oxaliplatin as investigator choice:
Patients who are positive for postoperative ctDNA (ctDNApos) and not microsatellite instable are randomized (2:1) to adjuvant chemotherapy with capecitabine or to follow up.
Capecitabine 2 x 1250 mg/m^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days). Patients with a GFR between 30 and 50 ml/min start with capecitabine dose of 2 x 1000 mg/m^2. Treatment duration: 8 cycles (approx. 6 months)
Capecitabine, if combined with Oxaliplatin (investigator choice):
If the investigation decides to add oxaliplatin, the following schedule should be used:
[Oxaliplatin 130 mg/m^2 i.v. (2 hours on d1)] Capecitabine 2 x 1000 mg/m^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days) Treatment duration: 4 or 8 cycles (approx. 3 or 6 months) Receives: Drug: Capecitabine |
| Follow-up | No intervention | Patients negative for postoperative ctDNA (ctDNAneg) are randomized (1:4) to follow-up within CIRCULATE or to routine follow up outside the Trial protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free Survival (DFS)
Disease free survival of ctDNA positive patients randomised to "chemotherapy" vs. "follow-up", measured from randomisation to any recurrence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
Interims analysis after 93 events (approx. 38 months after study start), final analysis for the primary endpoint after 154 events (approx. 60 months after study start).
Measured: for the primary endpoint after 154 events (approx. 60 months after study start)
Secondary outcomes (6)
Overall survival in ctDNApos patients with adjuvant therapy vs follow-up
Overall survival in ctDNApos patients with adjuvant therapy vs follow-up, measured from randomisation to death from any cause, in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
Measured: 5 years
Disease free survival in ctDNAneg patients randomised to follow up
Disease free survival in ctDNAneg patients randomised to follow up (rate of patients disease free and alive 3 years after randomisation according to Kaplan-Meier estimation with 95% CI, intention-to-treat analysis). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause is regarded as event (rate of patients disease free and alive 3 years after randomisation according to Kaplan-Meier estimation with 95% CI, intention-to-treat analysis). Any recurrence, metastasis, second colorectal or non- colorectal cancer and death from any cause is regarded as event
Measured: 3 years
Overall survival in ctDNAneg patients randomised to "follow up"
Overall survival in ctDNAneg patients randomised to "follow up" (rate of patients alive after 5 years after randomisation according to Kaplan-Meier estimation with 95% CI)
Measured: 5 years
Disease free and overall survival of ctDNApos vs. ctDNAneg patients randomized to "follow-up"
Disease free and overall survival of ctDNApos vs. ctDNAneg patients randomized to "follow-up" (measured from randomisation to the event in an intention-to-treat analysis by stratified log rank test). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause are regarded as event for DFS. Death of any cause will be regarded as event for overall survival.
Measured: 3 years and 5 years
Site of metastases
Site of metastases (lymph node vs. peritoneal/local recurrence vs other) in ctDNApos vs. ctDNAneg patients who have a recurrence / metastases
Measured: 5 years
Frequency of adverse events from start of chemotherapy until 30 days after chemotherapy
Frequency of adverse events from start of chemotherapy until 30 days after chemotherapy (descriptive analysis for patients randomised to "chemotherapy" who have received at least one dose of chemotherapy).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start26 Jun 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IIStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Folprecht, Prof., Principal investigator, University hospital "Carl Gustav Carus" Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089631
- Sponsor's protocol ID
- TUD-CIRC01-071
- Other IDs
- 2018-003691-12, 01KG1817, AIO-KRK-0217, 2018
- Acronym
- CIRCULATE
- Status last verified
- Aug 2020
- First submitted
- 9 Sep 2019
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217
- ClinicalTrials.gov ID
- NCT04089631
- Acronym / sponsor ID
- CIRCULATE / TUD-CIRC01-071
- Conditions
- Colon Cancer Stage II
- Keywords
- circulating tumour DNA, ctDNA, adjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,812 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.
Detailed description
CIRCULATE is an investigator-initiated, multicentre, prospective, randomised, controlled trial.
Screening phase:
Patients with colon cancer (or rectal cancer, if a radiation is not indicated i.e. due to the tumour localisation) are postoperatively screened for this trial.
For this purpose, they sign an informed consent for screening. The formalin fixed paraffin embedded (FFPE) tumour block is shipped to one of the central pathological laboratories and is analysed for microsatellite instability and by panel analysis for frequent mutations in the colorectal cancer. A plasma sample is sent in parallel to the central laboratory for ctDNA. The screening is preferably performed before the patient is discharged from the surgical department and at the latest 5 weeks after resection to allow sufficient time for the analysis.
The patient- specific tumour mutations known from the panel analysis are measure in the patients plasma by ultra deep sequencing. The results of the analysis - positive for circulating tumour DNA (ctDNApos) or negative for circulating tumour DNA (ctDNAneg) - is not communicated to the patient or the investigator.
Randomised phase:
Four to eight weeks after resection, the patient presents at an investigator that is experienced with chemotherapy (i.e. Medical Oncologist) and consent for the randomised part of the study with a second informed consent form. If this baseline visit confirms that there are not contraindications to chemotherapy and if no other exclusion criteria exist, the patient is randomised:
- ctDNApos patients are randomised (2:1) in "chemotherapy" (with capecitabine) or "follow-up",
- ctDNAneg patients are randomised (1:4) in "follow-up" or "off study" which means that the follow-up will be organised within the routine clinical practice.
The result of the ctDNA will not be communicated to the patients and investigators, so that patients in the arm "follow-up" remain blinded to the ctDNA result. Due to the randomisation ratio, the prognosis of these patients is similar to those in stage II without any ctDNA analysis and differs only slightly from patients not enrolled into a clinical trial.
Patients in the arm "chemotherapy" receive adjuvant therapy with 6 months capecitabine. The investigator can decide to add oxaliplatin and to shorten the adjuvant chemotherapy to 3 months if oxaliplatin is added.
Patients in the arms "chemotherapy" and "follow-up" are followed with the same methods and time point within the study.
Patients in the arm "off study" are recommended to be follow up according to the guidelines for stage II in the routine practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: CapecitabineCapecitabine mono or Capecitabine/Oxaliplatin as investigator choice: Patients who are positive for postoperative ctDNA (ctDNApos) and not microsatellite instable are randomized (2:1) to adjuvant chemotherapy with capecitabine or to follow up. Capecitabine 2 x 1250 mg/m^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days). Patients with a GFR between 30 and 50 ml/min start with capecitabine dose of 2 x 1000 mg/m^2. Treatment duration: 8 cycles (approx. 6 months) Capecitabine, if combined with Oxaliplatin (investigator choice): If the investigation decides to add oxaliplatin, the following schedule should be used: [Oxaliplatin 130 mg/m^2 i.v. (2 hours on d1)] Capecitabine 2 x 1000 mg/m^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days) Treatment duration: 4 or 8 cycles (approx. 3 or 6 months) |
| Follow-up | No intervention | –Patients negative for postoperative ctDNA (ctDNAneg) are randomized (1:4) to follow-up within CIRCULATE or to routine follow up outside the Trial protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 recommendations for colon cancer. Patients, in whom the tumour stage is not yet know, can be enrolled into the screening.
- Signed informed consent for the screening Phase
- 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 recommendations for colon cancer.
- Known microsatellite or mismatch repair status
- Confirmation, that the ctDNA result is available
Key exclusion criteria (39 listed)
- Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
- Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
- Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, 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 chemotherapy.
- R1- or R2-status (patients with [still] unknown R-status can be screened)
- Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: Xeloda6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine | Drug | Chemotherapy |
Primary outcome
Disease free Survival (DFS)
Time frame: for the primary endpoint after 154 events (approx. 60 months after study start)
Disease free survival of ctDNA positive patients randomised to "chemotherapy" vs. "follow-up", measured from randomisation to any recurrence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test. Interims analysis after 93 events (approx. 38 months after study start), final analysis for the primary endpoint after 154 events (approx. 60 months after study start).
6 secondary outcomes
Overall survival in ctDNApos patients with adjuvant therapy vs follow-up
Time frame: 5 years
Disease free survival in ctDNAneg patients randomised to follow up
Time frame: 3 years
Overall survival in ctDNAneg patients randomised to "follow up"
Time frame: 5 years
Disease free and overall survival of ctDNApos vs. ctDNAneg patients randomized to "follow-up"
Time frame: 3 years and 5 years
Site of metastases
Time frame: 5 years
Frequency of adverse events from start of chemotherapy until 30 days after chemotherapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Folprecht, Prof. principal investigator
University hospital "Carl Gustav Carus" Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine in people with Colon Cancer Stage II, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gunnar Folprecht, Prof. (+49 351 458 4794, Gunnar.Folprecht@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free Survival (DFS) (time frame: for the primary endpoint after 154 events (approx. 60 months after study start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.