Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 2 of 245428 for:    ALL

SULTAN (Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network) (SULTAN)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by UNICANCER
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT03164655
First received: May 22, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose
National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy.

Condition Intervention Phase
Colorectal Cancer Metastatic
Drug: Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5Fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study Comparing Treatment Intensification With Hepatic Arterial Infusion Chemotherapy Plus Systemic Chemotherapy to Systemic Chemotherapy Alone in Patients With Liver-only Colorectal Metastases Considered Still Non Resectable After at Least Two Months of Systemic Induction Chemotherapy: SULTAN (Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network)

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Curative-intent (R0-R1) resection (and/or ablation) rate (CRR) of CRLM [ Time Frame: 6 months ]
    Curative-intent (R0-R1) resection (and/or ablation) rate (CRR) of CRLM confirmed by a systematic review of the surgical and pathological report by an independent committee blind to the treatment received


Estimated Enrollment: 140
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAI oxaliplatin combined with I.V. FOLFIRI + target therapy
  • HAI oxaliplatin 100 mg/m² in 2 hours on day 1 (D1),
  • I.V. cetuximab 500 mg/m2 in 2 hours or panitumumab 6 mg/kg over one hour or bevacizumab 5 mg/kg in 30 min D1 according to RAS status and prior response/tolerance to systemic induction CT
  • modified FOLFIRI regimen without fluorouracil bolus
  • I.V. irinotecan 180 mg/m2 D1
  • I.V. bolus 5FU: 0
  • I.V. leucovorin 400 mg/m² in 2 hours D1, followed by
  • I.V. continuous infusion 5FU 2400 mg/m² in 46 hours
Drug: Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5Fluorouracil
Oxaliplatin 100mg/m² infusion in 2 hours, Cetuximab 500mg/m² infusion in 2 hours, Bevacizumab 5mg/kg infusion in 30 minutes, Panitumumab 6mg/kg, Irinotecan 180mg/m² over 90 minutes to begin 30 minutes after folinic acid infusion is started, Leucovorin 400mg/m² infusion in 2 hours, 5Fluorouracil 2400mg/m² infusion continuous in 46h
Active Comparator: conventional systemic CT alone

Chemotherapy regimen defined by the investigator according to:

  • Response to systemic induction CT
  • Toxicity and duration of the systemic induction CT
  • RAS status
  • Current guidelines/standard of care
Drug: Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5Fluorouracil
Oxaliplatin 100mg/m² infusion in 2 hours, Cetuximab 500mg/m² infusion in 2 hours, Bevacizumab 5mg/kg infusion in 30 minutes, Panitumumab 6mg/kg, Irinotecan 180mg/m² over 90 minutes to begin 30 minutes after folinic acid infusion is started, Leucovorin 400mg/m² infusion in 2 hours, 5Fluorouracil 2400mg/m² infusion continuous in 46h

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed colorectal cancer (CRC), and radiologic or histologic proof of CRLM
  2. CRLM not amenable to a curative intent-treatment after at least two months and no more than 6 months of first-line induction CT
  3. First-line CT with oxaliplatin and/or irinotecan combined with a fluoropyrimidine and a targeted therapy (e.g., anti-EGFR or antiangiogenic antibody) for metastatic disease (patients ending their adjuvant chemotherapy after primary tumor resection since less than 6 months should also have received first-line chemotherapy for metastatic desease)
  4. Unresectability of the CRLM will be confirmed by a centralized multidisciplinary expert panel (composed of surgeons, radiologists, interventional radiologists and medical oncologists). The panel will review the CT-Scan and MRI of the patients (weekly web conference)
  5. Non-resectability criteria (one of the following criteria):

    • Upfront R0/R1 resection of all CRLM (that leaves at least two adequately perfused and drained segments) is not possible
    • and/or metastases in contact with major vessels of the remnant liver which would require resection of the vessel for an R0 resection (i.e., tumor involvement of main portal right and left portal veins, of the three main hepatic veins, or of the retrohepatic vena cava)
    • and/or documented progressive disease on imaging (according to the RECIST v1.1 criteria) or doubling of serum levels of carcinoembryonic antigen (CEA) or CA 19.9 following ≥ 2 months of induction CT
  6. At least one measurable liver metastasis according to the RECIST v1.1
  7. Age ≥ 18 years
  8. ECOG performance status 0-1
  9. Normal liver function, i.e. bilirubin < 1.5 times the upper limit of normal values (ULN), aminotransferases < 5ULN, alkaline phosphatase < 5ULN
  10. International normalized ratio (INR) < 1.5ULN
  11. Neutrophils > 1500/mm3, platelets > 100 000/mm3, haemoglobin > 9 g/dL (transfusion allowed)
  12. Calculated creatinine clearance > 50 mL/min (Cockcroft and Gault formula)
  13. Informed consent signed by the patient or his/her legal representative
  14. Patient affiliated to a social security regimen
  15. Adequate contraception if applicable

Exclusion Criteria:

  1. Patient eligible for curative-intent treatment of CRLM (i.e. resection and/or thermoablation), according to the local multidisciplinary team and/or the central review.
  2. Extrahepatic tumour disease (except ≤ 3 lung nodules < 10 mm deemed amenable to curative-intent resection/thermoablation and non-resected primary tumour with no or mild symptoms)
  3. Patient with contraindication for trial drugs (investigators have to refer to SmPC drugs, see appendix 1)
  4. Sensory neuropathy ≥ grade 2 (NCIC CTAE v.4.0)
  5. Significant chronic liver disease (resulting in portal hypertension and/or liver insufficiency)
  6. Allergy to contrast media that cannot be managed with standard care
  7. Previous organ transplantation, HIV or other immunodeficiency syndromes
  8. Concomitant or past history of cancer within 5 years prior to entry into the trial other than adequately treated basal-cell skin cancer or in situ carcinoma of the cervix
  9. Concomitant medications/comorbidities that may prevent the patient from receiving study treatments as uncontrolled intercurrent illness (for instance: active infection, active inflammatory disorders, inflammatory bowel disease, intestinal obstruction, symptomatic congestive heart failure, uncontrolled hypertension…)
  10. Ionic disorders as:

    • Kalemia ≤ 1 x ULN
    • Magnesemia < 0.5 mmol/L
    • Calcemia < 2 mmol/L
  11. Patient with known dihydropyrimidine dehydrogenase deficiency
  12. QT/QTc > 450 msec for men and > 470 msec for women
  13. Concomitant intake of St. John's wort
  14. Patient already included in another clinical trial with an experimental molecule
  15. Pregnancy or lactation
  16. Patients deprived of liberty or under guardianship
  17. Patients unable to undergo medical monitoring test for geographical, social or psychological reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03164655

Contacts
Contact: Sandra PELISSIER 0144235568 s-pelissier@unicancer.fr

Sponsors and Collaborators
UNICANCER
  More Information

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03164655     History of Changes
Other Study ID Numbers: UCGI 30 - PRODIGE 53 SULTAN
2016-001493-15 ( EudraCT Number )
Study First Received: May 22, 2017
Last Updated: May 22, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Oxaliplatin
Irinotecan
Cetuximab
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2017