AzTrials
AzTrials

Stage II Colon CancerPhase 2ERASE-CRCNCT05062889

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

A Phase 2 study testing 5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule and 5-Fluorouracil continuous infusion FOLFOX schedule in people with Stage II Colon Cancer and Stage III Colon Cancer, run by Gruppo Oncologico del Nord-Ovest at 28 sites in Italy.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule and 5-Fluorouracil continuous infusion FOLFOX schedule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
477 participants
Where
28 sitesItaly
Study dates
17 May 2023to Dec 2029
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent to study procedures;
  • 18 - 70 years of age ECOG Performance Status ≤ 1 or 71-75 years of age with ECOG Performance Status 0;
  • Histologically confirmed stage III or high-risk stage II adenocarcinoma of colon including intraperitoneal rectal cancer. Stage II colon cancers are defined at high risk if at least one major prognostic factor (pT4, less than 12 nodes examined, clinical presentation with bowel perforation) or at least two minor prognostic factors (grade 3 or 4, clinical presentation with bowel obstruction, histological signs of vascular or lymphatic or perineural invasion, high preoperative CEA levels) are reported;
  • Curative surgery performed no less than 4 and no more than 12 weeks prior to randomization (pending results of ct-DNA analysis, up to 2 cycles of FOLFOX/CAPOX are allowed to start the adjuvant treatment within 8-10 weeks after surgery);
  • Contrast-enhanced chest and abdominal CT scan (or abdomen MRI and chest CT if contrast-enhanced CT scan is contraindicated) performed after the surgery and prior to randomization with no evidence of metastatic disease;
  • Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue from the surgical specimen and blood sample for ct-DNA analysis within 28 days prior randomization;
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  • Positive ct-DNA after surgery (central assessment);
  • Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl;
  • Total bilirubin ≤1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase ≤2.5 x UNL (or <5 x UNL in case of liver metastases);
  • Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5 x UNL;
  • Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless the participants are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
  • Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception.
  • Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
  • Will and ability to comply with the protocol.
  • Inclusion Criteria Part 1 and target-driven part 1, adjuvant phase II study
  • Written informed consent to study procedures;
  • 18 - 70 years of age ECOG PS ≤ 1 or 71-75 years of age with ECOG PS 0;
  • Histologically confirmed stage III or high-risk stage II adenocarcinoma of colon including intraperitoneal rectal cancer. Stage II colon cancers are defined at high risk if at least one major prognostic factor (pT4, less than 12 nodes examined, clinical presentation with bowel perforation) or at least two minor prognostic factors (grade 3 or 4, clinical presentation with bowel obstruction, histological signs of vascular or lymphatic or perineural invasion, high preoperative CEA levels) are reported;
  • For target-driven Part 1 only: HER2+ and RAS wt disease as determined by a tissue-based assay (central laboratory assessment);
  • Curative surgery performed no less than 4 and no more than 12 weeks prior to randomization (pending results of ct-DNA analysis, up to 2 cycles of FOLFOX/CAPOX are allowed to start the adjuvant treatment within 8-10 weeks after surgery);
  • Contrast-enhanced chest and abdominal CT scan (or abdomen MRI and chest CT if contrast-enhanced CT scan is contraindicated) performed after the surgery and prior to randomization with no evidence of metastatic disease;
  • Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue from the surgical specimen and blood sample for ct-DNA analysis within 28 days prior randomization;
  • Positive ct-DNA after surgery (central assessment);
  • Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl;
  • Total bilirubin ≤1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL, alkaline phosphatase ≤2.5 x UNL;
  • Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5 x UNL;
  • For target-driven Part 1 only: Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
  • Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue from the surgical specimen for translational analysis (only for patients eligible for protocol treatment);
  • Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
  • Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception. Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
  • Will and ability to comply with the protocol.
  • Written informed consent to study procedures;
  • ≥ 18 years of age;
  • Histologically confirmed stage III or high-risk stage II adenocarcinoma of colon including intraperitoneal rectal cancer. Stage II colon cancers are defined at high risk if at least one major prognostic factor (pT4, less than 12 nodes examined, clinical presentation with bowel perforation) or at least two minor prognostic factors (grade 3 or 4, clinical presentation with bowel obstruction, histological signs of vascular or lymphatic or perineural invasion, high preoperative CEA levels) are reported;
  • Fluoropyrimidine and oxaliplatin-containing adjuvant treatment for at least 3 months (6 cycles of 5-fluorouracil and oxaliplatin-based therapy or 4 cycles of capecitabine and oxaliplatin-based-therapy) and no more than 6 months (12 cycles of 5-fluorouracil and oxaliplatin-based therapy or 8 cycles of capecitabine and oxaliplatin-based-therapy);
  • Contrast-enhanced chest and abdominal CT scan (or abdomen MRI and chest CT if contrast-enhanced CT scan is contraindicated) performed within 4 weeks from the end of adjuvant therapy and 28 days prior to randomization;
  • Availability of FFPE tumor tissue from the surgical specimen and blood sample for ct-DNA analysis within 28 days prior to randomization;
  • Positive ct-DNA after the end of adjuvant treatment (centrally laboratory assessment);
  • ECOG Performance Status ≤ 1;
  • Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥9 g/dl;
  • Total bilirubin ≤1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase ≤2.5 x UNL (or <5 x UNL in case of liver metastases);
  • Creatinine clearance ≥ 50 mL/min or serum creatinine ≤1.5 x UNL;
  • Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless the participants are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;.
  • Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception.
  • Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
  • Will and ability to comply with the protocol.

Who cannot join

  • Part 1, adjuvant phase and Part 2, post-adjuvant phase
  • Any evidence of metastatic disease (radiological or pathological metastasis);
  • Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections) after surgery;
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
  • For Part 1 only: patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT);
  • History or evidence upon physical examination of CNS disease unless adequately treated;
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  • Clinical signs of malnutrition;
  • Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration;
  • Evidence of bleeding diathesis or coagulopathy;
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication;
  • Significant vascular disease (i.e. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment;
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication;
  • Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer);
  • Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs;
  • Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies;
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at screening. Sexually active males and females (of childbearing potential) unwilling to practice contraception (as defined in section 5.5) during the study and until 180 days after the last trial treatment.
  • Part 1, target-driven, adjuvant phase:
  • Ongoing ≥ Grade 2 diarrhea of any etiology at screening;
  • Presence of known chronic liver disease;
  • Known to be positive for hepatitis C infection (positive by polymerase chain reaction [PCR]). Subjects who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of at least 12 weeks.
  • Known to be positive for hepatitis B (HBV) by surface antigen (HBsAg) expression. Subjects who are positive for either hepatitis B surface antibody (HBsAB) or antibodies to the hepatitis B core antigen (HBcAB) should be screened using PCR measurement of hepatitis B DNA levels. Subjects with hepatitis B DNA levels by PCR that require nucleoside analogue therapy are not eligible for the trial. The latest local guidelines should be followed regarding the monitoring of hepatitis B DNA levels by PCR subjects on study treatment.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Italy28 sites

  • Ospedale San Donato di Arezzo

    Arezzo, 52100

  • Spedali Civili di Brescia

    Brescia, 25123

  • Fondazione POLIAMBULANZA ISTITUTO OSPEDALIERO

    Brescia, 25124

  • AOU Cagliari PO Policlinico Universitario Duilio Casula Presidio Policlinico Universitario "Duilio Casula"

    Cagliari, 09042

  • A.O.U. di Ferrara Arcispedale Sant'Anna

    Ferrara, 44100

  • A.O.U Careggi

    Florence, 50134

  • E.O. Ospedali Galliera di Genova

    Genova, 16128

  • Ospedale Misericordia di Grosseto

    Grosseto, 58100

  • Azienda USL Toscana Nord Ovest di Livorno

    Livorno, 57124

  • Ospedale San Luca di Lucca

    Lucca, 55100

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola, 47014

  • Fondazione IRCCS INT - Milano

    Milan, 20133

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    Novara, 28100

  • Istituto Oncologico Veneto IOV - IRCCS

    Padua, 35128

  • Azienda USL di Piacenza

    Piacenza, 29121

  • Nuovo Ospedale di Prato

    Prato, 59100

  • AUSL Romagna

    Ravenna, 48121

  • Azienda USL IRCCS di Reggio Emilia (centro principale Reggio Emilia e centro satellite Guastalla).

    Reggio Emilia, 42123

  • Policlinico Tor Vergata Roma

    Roma, 00133

  • Istituto per la ricerca sui tumori Regina Elena

    Roma, 00144

  • Policlinico Fondazione Agostino Gemelli

    Roma, 00168

  • Ospedale Fatebenefratelli Isola Tiberina

    Roma, 00186

  • Fondazione Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Ospedale Campostaggia Poggiponsi

    Siena, 53100

  • IRCCS di Candiolo

    Torino, 10060

  • Azienda Ospedaliera Cardinale Giovanni Panico

    Tricase, Lecce, 73039

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, 33100

Other trials in Italy

About this study

Official title: Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment of Stage III and High-risk Stage II Resected Colon Cancer Patients With Adjuvant FOLFOXIRI and/or Post-adjuvant Trifluridine/Tipiracil

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse.

An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX

Read the detailed description

This is a prospective, open-label, multicentre study, including two phase II randomized trials. In Part 1 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after surgery will be randomized to receive FOLFOX for 12 cycles or CAPOX for 8 cycles (at investigator choice) versus FOLFOXIRI for 12 cycles.

In Part 1 target-driven resected stage III and high-risk stage II HER2+ and RAS wild-type colon cancer patients with positive ct-DNA after surgery will receive Trastuzumab and Tucatinib plus FOLFOX for 12 cycles.

In Part 2 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after the end of a fluoropyrimidine and oxaliplatin-based adjuvant therapy - either in the frame or outside of Part 1 - will be randomized to receive observation or Trifluridine/Tipiracil for 6 cycles.

Being tested
5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule, 5-Fluorouracil continuous infusion FOLFOX schedule, Oxaliplatin FOLFOX and FOLFOXIRI schedule, Oxaliplatin CAPOX schedule
Keywords
Circulating tumor DNA, FOLFOX, CAPOX, FOLFOXIRI, Trifluridine/Tipiracil, Trastuzumab, Tucatinib
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-Fluorouracil continuous infusion FOLFOXIRI scheduleDrug

    Also called 5FU

    3200 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • 5-Fluorouracil bolus FOLFOX scheduleDrug

    Also called 5FU

    400 mg/sqm iv bolus, day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • 5-Fluorouracil continuous infusion FOLFOX scheduleDrug

    Also called 5FU

    2400 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • Oxaliplatin FOLFOX and FOLFOXIRI scheduleDrug

    Also called Oxa

    85 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • Oxaliplatin CAPOX scheduleDrug

    Also called Oxa

    130 mg/sqm iv over 2 hours, day 1. To be repeated every three weeks for a maximum of 8 cycles.

  • L-LeucovorinDrug

    Also called Lederfolin

    200 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • CapecitabineDrug

    Capecitabine 1000 mg/sqm/bid per os from day 1 to day 14. To be repeated every 3 weeks until 8 cycles. Available as 500 and 150 mg tablets.

  • IrinotecanDrug

    165 mg/sqm iv over 60 minutes, day 1. To be repeated every two weeks for a maximum of 12 cycles.

  • Trifluridine/TipiracilDrug

    Also called FTD/TPI

    35 mg/m2/bid per os days 1-5 and 8-12. To be repeated every 4 weeks until 6 cycles. Available as 20 and 15 mg tablets.

  • TrastuzumabDrug

    4 mg/kg iv over 30 minutes, day 1 (loading dose: 6 mg/kg iv over 90 minutes). To be repeated every two weeks for a maximum of 12 cycles.

  • TucatinibDrug

    300 mg (two 150 mg tablets)/bid orally twice daily (approximately 8 to 12 hours between doses with or without a meal) for a maximum of 12 biweekly cycles.

Study groups in NCT05062889
Study groupRoleWhat they receive
Arm B FOLFOXIRI, part 1 (adjuvant)ExperimentalFOLFOXIRI Irinotecan 165 mg/sqm iv over 60 minutes day 1, followed by Oxaliplatin 85 mg/sqm iv over 2 hours day 1, in two-way with L-Leucovorin 200 mg/sqm iv over 2 hours, day 1 followed by 5-fluoruracil 3200 mg/sqm 48 h-continuous infusion, starting on day 1; to be repeated every 2 weeks for a maximum of 12 cycles. In the case of oxaliplatin and/or irinotecan interruption because of adverse events, patient's refusal or investigator's choice, the continuation of the other drugs until 12 cycles is recommended.
Receives: Drug: 5-Fluorouracil continuous infusion FOLFOXIRI schedule; Drug: Oxaliplatin FOLFOX and FOLFOXIRI schedule; Drug: L-Leucovorin; Drug: Irinotecan
Arm A mFOLFOX6 or CAPOX (at investigator's choice), part 1 (adjuvant)Active comparatormFOLFOX6 Oxaliplatin 85 mg/sqm iv over 2 hours, day 1 in two-way with L-Leucovorin 200 mg/sqm iv over 2 hours, day 1 followed by 5-fluorouracil 400 mg/sqm iv bolus, day 1 followed by 5-fluoruracil 2400 mg/sqm 48 h-continuous infusion, starting on day 1; to be repeated every 2 weeks for a maximum of 12 cycles. The continuation of 5FU/leucovorin until 12 cycles is recommended also if oxaliplatin is interrupted because of adverse events, patient's refusal or investigator's choice. CAPOX Oxaliplatin 130 mg/sqm iv over 2 hours, day 1; Capecitabine 1000 mg/sqm/bid per os from day 1 to day 14; to be repeated every 3 weeks until 8 cycles. The continuation of Capecitabine until 8 cycles is recommended also if oxaliplatin is interrupted because of adverse events, patient's refusal or investigator's choice. Pending the results of ct-DNA analysis, up to 2 cycles of FOLFOX/CAPOX before randomization are allowed to start the adjuvant treatment within 8-10 weeks after surgery
Receives: Drug: 5-Fluorouracil bolus FOLFOX schedule; Drug: 5-Fluorouracil continuous infusion FOLFOX schedule; Drug: Oxaliplatin FOLFOX and FOLFOXIRI schedule; Drug: Oxaliplatin CAPOX schedule; Drug: L-Leucovorin; Drug: Capecitabine
Trastuzumab and Tucatinib plus mFOLFOX6, part 1 target-driven (adjuvant)ExperimentalTucatinib 300 mg (two 150 mg tablets)/bid orally twice daily (approximately 8 to 12 hours between doses with or without a meal); Trastuzumab 4 mg/kg iv over 30 minutes, day 1 (loading dose: 6 mg/kg iv over 90 minutes), followed by mFOLFOX6 Oxaliplatin 85 mg/sqm iv over 2 hours, day 1 in two-way with L-Leucovorin 200 mg/sqm iv over 2 hours, day 1 followed by 5-fluorouracil 400 mg/sqm iv bolus, day 1 followed by 5-fluoruracil 2400 mg/sqm 48 h-continuous infusion, starting on day 1; to be repeated every 2 weeks for a maximum of 12 cycles. In the case of oxaliplatin and/or trastuzumab and/or tucatinib interruption because of adverse events, patient's refusal or investigator's choice, the prosecution of the other drugs until 12 cycles is recommended. Pending the results of ct-DNA analysis, up to 2 cycles of FOLFOX/CAPOX before randomization are allowed to start the adjuvant treatment within 8-10 weeks after surgery
Receives: Drug: 5-Fluorouracil bolus FOLFOX schedule; Drug: 5-Fluorouracil continuous infusion FOLFOX schedule; Drug: Oxaliplatin FOLFOX and FOLFOXIRI schedule; Drug: Oxaliplatin CAPOX schedule; Drug: L-Leucovorin; Drug: Trastuzumab; Drug: Tucatinib
Arm B Trifluridine/Tipiracil, part 2 (post-adjuvant)ExperimentalTrifluridine/Tipiracil: 35 mg/ m2/bid per os days 1-5 and 8-12 to be repeated every 4 weeks until 6 cycles.
Receives: Drug: Trifluridine/Tipiracil
Arm A Observation, part 2 (post-adjuvant)No interventionFollow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ct-DNA clearance rate after the end of the adjuvant treatment (ERASE-CRC part 1)

    Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study with undetectable ct-DNA at the end of adjuvant treatment.

    Measured: 6 months from the enrollment of the last patient in the adjuvant treatment

  2. ct-DNA clearance rate after the end of post-adjuvant treatment (ERASE-CRC part 2)

    Percentage of patients, relative to the total of enrolled subjects in the Part 2 of the study with undetectable ct-DNA at the end of post-adjuvant treatment.

    Measured: 6 months from the enrollment of the last patient in post-adjuvant treatment

  3. ct-DNA clearance rate after the end of target-driven adjuvant treatment (ERASE-CRC part 1 target-driven)

    Percentage of patients, relative to the total of enrolled subjects in the target-driven part

    1 of the study with undetectable ct-DNA at the end of adjuvant treatment.

    Measured: 6 months from the enrollment of the last patient in the target-driven adjuvant treatment

Secondary outcomes (12)

  1. Overall Toxicity Rate 1

    Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up.

    Measured: 30 days from the last dose of the last patient in adjuvant treatment

  2. Toxicity Rate 1

    Percentage of patients, relative to the total of enrolled subjects in the Part 1 of the study, experiencing a specific adverse event of grade ≥ 3, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up.

    Measured: 30 days from the last dose of the last patient in adjuvant treatment

  3. Disease Free Survival 1 (DFS1)

    Time from randomization of the part 1 of the study to the first documentation of radiological disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after randomization will have time to event censored on the date of randomization.

    Measured: 60 months after the randomization of first patient in adjuvant treatment

  4. Overall Survival 1 (OS1)

    Time from randomization of the Part 1 of the study to the date of death due to any cause. For patients still alive at the time of the analysis, the OS time will be censored on the last date the patients were known to be alive.

    Measured: 60 months after the randomization of first patient in adjuvant treatment

  5. Overall Toxicity Rate 2

    Percentage of patients in the Part 2 of the study, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during post-adjuvant treatment and follow-up.

    Measured: 30 days from the last dose of TRIFLURIDINE/TIPIRACIL

  6. Toxicity Rate 2

    Percentage of patients, relative to the total of enrolled subjects in the Part 2 of the study, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during postadjuvant treatment and follow-up.

    Measured: 30 days from the last dose of TRIFLURIDINE/TIPIRACIL

  7. Disease Free Survival 2 (DFS2)

    Time from randomization of the part 2 of the study to the first radiological documentation of disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after randomization will have time to event censored on the date of randomization.

    Measured: 60 months after the randomization of first patient in post-adjuvant treatment

  8. Overall Survival 2 (OS2)

    Time from randomization of the part 2 of the study to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.

    Measured: 60 months after the randomization of first patient in post-adjuvant treatment

  9. Overall Toxicity Rate TD1

    Percentage of patients, relative to the total of enrolled subjects in the target-driven part 1 of the study, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up.

    Measured: 30 days from the last dose of the last patient in target-driven adjuvant treatment

  10. Toxicity Rate TD1

    percentage of patients, relative to the total of enrolled subjects in the target-driven part 1 of the study, experiencing a specific adverse event ≥ grade 3, according to National Cancer Institute Common Toxicity Criteria (version 5.0), during adjuvant treatment and follow-up.

    Measured: 30 days from the last dose of the last patient in target-driven adjuvant treatment

  11. Disease Free Survival TD1 (DFS-TD1)

    time from enrollment of the target-driven part 1 of the study to the first documentation of disease relapse or death due to any cause, whichever occurs first. Secondary colorectal cancers are regarded as DFS events, whereas non-colorectal tumors are not. DFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of relapse for patients who are alive, on study and disease free at the time of the analysis. Alive patients having no tumor assessments after enrollment will have time to event censored on the date of enrollment.

    Measured: 60 months after the randomization of first patient in adjuvant treatment

  12. Overall survival TD1 (OS-TD1)

    Time from enrollment of the target-driven part 1 of the study to the date of death due to any cause. For patients still alive at the time of the analysis, the OS time will be censored on the last date the patients were known to be alive.

    Measured: 60 months after the randomization of first patient in adjuvant treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2021
  2. Study start17 May 2023
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Why it stopped: due to earlier termination of the agreement between the Sponsor and Central Laboratory for screening test. Enrollment will reopen as soon as a new laboratory is identified.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This is a prospective, open-label, multicentre study, including two phase II randomized trials (Part 1 and Part 2) and a non-randomized cohort (Part 1 target-driven) In Part 1 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after surgery will be randomized to receive FOLFOX for 12 cycles or CAPOX for 8 cycles (at investigator choice) versus FOLFOXIRI for 12 cycles; In Part 1 target-driven resected stage III and high-risk stage II HER2+ RAS wild-type colon cancer patients with positive ct-DNA after surgery will receive Trastuzumab and Tucatinib plus FOLFOX for 12 cycles. In Part 2 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after the end of a fluoropyrimidine and oxaliplatin-based adjuvant therapy - either in the frame or outside of Part 1 - will be randomized to receive observation or Trifluridine/Tipiracil for 6 cycles.
Masking
None (open label)
Enrolment
477 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05062889
Sponsor's protocol ID
ERASE-CRC
Acronym
ERASE-CRC
Status last verified
Jan 2026
First submitted
13 Sep 2021
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-Fluorouracil continuous infusion FOLFOXIRI schedule, 5-Fluorouracil bolus FOLFOX schedule and 5-Fluorouracil continuous infusion FOLFOX schedule in people with Stage II Colon Cancer and Stage III Colon Cancer, run by Gruppo Oncologico del Nord-Ovest at 28 sites in Italy.

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 46 inclusion and 21 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: paused, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ct-DNA clearance rate after the end of the adjuvant treatment (ERASE-CRC part 1) (time frame: 6 months from the enrollment of the last patient in the adjuvant treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05062889.

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 3 Feb 2026.

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