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

NCT ID: NCT05062889

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 477 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2027-12-31

Brief 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 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

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.

Conditions

Stage II Colon Cancer; Stage III Colon Cancer; HER2-positive Colon Cancer; RAS Wild-type Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B FOLFOXIRI, part 1 (adjuvant)

FOLFOXIRI 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.

Group Type: EXPERIMENTAL

5-Fluorouracil continuous infusion FOLFOXIRI schedule

Intervention Type: DRUG

3200 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 schedule

Intervention Type: DRUG

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

L-Leucovorin

Intervention Type: DRUG

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

Irinotecan

Intervention Type: DRUG

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

Arm A mFOLFOX6 or CAPOX (at investigator's choice), part 1 (adjuvant)

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. 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

Group Type: ACTIVE_COMPARATOR

5-Fluorouracil bolus FOLFOX schedule

Intervention Type: DRUG

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

5-Fluorouracil continuous infusion FOLFOX schedule

Intervention Type: DRUG

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 schedule

Intervention Type: DRUG

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

Oxaliplatin CAPOX schedule

Intervention Type: DRUG

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

L-Leucovorin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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.

Trastuzumab and Tucatinib plus mFOLFOX6, part 1 target-driven (adjuvant)

Tucatinib 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

Group Type: EXPERIMENTAL

5-Fluorouracil bolus FOLFOX schedule

Intervention Type: DRUG

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

5-Fluorouracil continuous infusion FOLFOX schedule

Intervention Type: DRUG

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 schedule

Intervention Type: DRUG

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

Oxaliplatin CAPOX schedule

Intervention Type: DRUG

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

L-Leucovorin

Intervention Type: DRUG

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

Trastuzumab

Intervention Type: DRUG

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.

Tucatinib

Intervention Type: DRUG

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.

Arm B Trifluridine/Tipiracil, part 2 (post-adjuvant)

Trifluridine/Tipiracil: 35 mg/ m2/bid per os days 1-5 and 8-12 to be repeated every 4 weeks until 6 cycles.

Group Type: EXPERIMENTAL

Trifluridine/Tipiracil

Intervention Type: DRUG

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.

Arm A Observation, part 2 (post-adjuvant)

Follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

5-Fluorouracil continuous infusion FOLFOXIRI schedule

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

Intervention Type: DRUG

5-Fluorouracil bolus FOLFOX schedule

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

Intervention Type: DRUG

5-Fluorouracil continuous infusion FOLFOX schedule

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

Intervention Type: DRUG

Oxaliplatin FOLFOX and FOLFOXIRI schedule

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

Intervention Type: DRUG

Oxaliplatin CAPOX schedule

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

Intervention Type: DRUG

L-Leucovorin

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

Intervention Type: DRUG

Capecitabine

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.

Intervention Type: DRUG

Irinotecan

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

Intervention Type: DRUG

Trifluridine/Tipiracil

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.

Intervention Type: DRUG

Trastuzumab

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.

Intervention Type: DRUG

Tucatinib

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.

Intervention Type: DRUG

Other Intervention Names

5FU; 5FU; 5FU; Oxa; Oxa; Lederfolin; FTD/TPI

Eligibility Criteria

Inclusion Criteria

• 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;
• 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.

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servier

INDUSTRY

Sponsor Role: collaborator

Foundation Medicine

INDUSTRY

Sponsor Role: collaborator

Seagen Inc.

INDUSTRY

Sponsor Role: collaborator

Gruppo Oncologico del Nord-Ovest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Moretto, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero, Universitaria Pisana

Locations

Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Site Status: RECRUITING

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Lecce, Italy

Site Status: RECRUITING

Ospedale San Donato di Arezzo

Arezzo, , Italy

Site Status: RECRUITING

Spedali Civili di Brescia

Brescia, , Italy

Site Status: RECRUITING

Fondazione POLIAMBULANZA ISTITUTO OSPEDALIERO

Brescia, , Italy

Site Status: RECRUITING

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

Cagliari, , Italy

Site Status: RECRUITING

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

Ferrara, , Italy

Site Status: RECRUITING

A.O.U Careggi

Florence, , Italy

Site Status: RECRUITING

E.O. Ospedali Galliera di Genova

Genova, , Italy

Site Status: RECRUITING

Ospedale Misericordia di Grosseto

Grosseto, , Italy

Site Status: RECRUITING

Azienda USL Toscana Nord Ovest di Livorno

Livorno, , Italy

Site Status: RECRUITING

Ospedale San Luca di Lucca

Lucca, , Italy

Site Status: RECRUITING

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, , Italy

Site Status: RECRUITING

Fondazione IRCCS INT - Milano

Milan, , Italy

Site Status: RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carita

Novara, , Italy

Site Status: RECRUITING

Istituto Oncologico Veneto IOV - IRCCS

Padua, , Italy

Site Status: RECRUITING

Azienda USL di Piacenza

Piacenza, , Italy

Site Status: RECRUITING

Nuovo Ospedale di Prato

Prato, , Italy

Site Status: RECRUITING

AUSL Romagna

Ravenna, , Italy

Site Status: RECRUITING

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

Reggio Emilia, , Italy

Site Status: RECRUITING

Policlinico Tor Vergata Roma

Roma, , Italy

Site Status: RECRUITING

Istituto per la ricerca sui tumori Regina Elena

Roma, , Italy

Site Status: RECRUITING

Policlinico Fondazione Agostino Gemelli

Roma, , Italy

Site Status: RECRUITING

Ospedale Fatebenefratelli Isola Tiberina

Roma, , Italy

Site Status: RECRUITING

Ospedale Campostaggia Poggiponsi

Siena, , Italy

Site Status: RECRUITING

IRCCS di Candiolo

Torino, , Italy

Site Status: RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale

Udine, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Moretto, MD

Role: CONTACT

robertomoretto8468@gmail.com

+39050992069

Chiara Cremolini, MD, PhD

Role: CONTACT

chiaracremolini@gmail.com

+39050992069

Facility Contacts

Tiziana Pia Latiano

Role: primary

Emiliano Tamburini

Role: primary

Carlo Milandri

Role: primary

Giuseppina Arcangeli

Role: primary

Alberto Zaniboni

Role: primary

Mario Scartozzi

Role: primary

Ilaria Carandina

Role: primary

Lorenzo Antonuozzo

Role: primary

Matteo Clavarezza

Role: primary

Carmelo Bengala

Role: primary

Samanta Cupini

Role: primary

Editta Baldini

Role: primary

Giovanni L Frassineti

Role: primary

Filippo Pietrantonio

Role: primary

Monica Ronzoni

Role: primary

Laura Giovanna Forti

Role: primary

Sara Lonardi

Role: primary

Elena Orlandi

Role: primary

Samanta Di Donato

Role: primary

Stefano Tamberi

Role: primary

Maria Banzi

Role: primary

Vincenzo Formica

Role: primary

Massimo Zeuli

Role: primary

Giampaolo Tortora

Role: primary

Domenico Cristiano Corsi

Role: primary

Angelo Martignetti

Role: primary

Elisabetta Fenocchio

Role: primary

Maria Elena Casagrande

Role: primary

Other Identifiers

ERASE-CRC

Identifier Type: -

Identifier Source: org_study_id