Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Liver Extracts

Folinic Acid

started within 8 weeks after surgery for a maximal duration of 6 months and at least 3 months, every 14 days:

* Oxaliplatin 85 mg/m² in 2 hours IV day (D)1,
* Acide folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg/m² IV in 46 hours.

started within 8 weeks after surgery for a maximal duration of 6 months and at least 3 months, and performed every 14 days:

* Oxaliplatin 85 mg/m² in 4-6 hours HAI day (D)1,
* Acide Folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg / m² IV in 46 hours. In both arms, continuation of targeted therapy (if any) used in the preoperative treatment is allowed.

Oxaliplatin 85 mg/m² in 2 hours HAI day (D)1,

Oxaliplatin HAI

Oxaliplatin 85 mg/m² in 2 hours IV day (D)1,

Oxaliplatin IV

Acide folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg/m² IV in 46 hours.

mFOLFOX6

Acide Folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg / m² IV in 46 hours.

LV5FU2

Currently, no adjuvant study with hepatic arterial infusion in the adjuvant setting is opened. Recently, the results of a phase II study (NCT00268463, NSABP-C-09) assessing the potential benefit of systemic oxaliplatin and capecitabine alternating with HAI of FUDR, after resection of CRLM have been reported.

The primary end point was 2-year survival. Fifty-five of 76 eligible patients were able to initiate protocol-directed therapy and completed median of six cycles (range, one to six). Three postoperative or treatment-related deaths were reported. Overall, 88% of evaluable patients were alive at 2 years. With a median followup of 4.8 years, a total of 30 patients have had disease recurrence, 11 involving the liver. Median disease-free survival was 32.7 months. In conclusion alternating HAI of FUDR and systemic capecitabine and oxaliplatin met the prespecified end point of higher than 85% survival at 2 years and were clinically tolerable.

Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases

Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases - A Randomized Phase II/III Trial

National Cancer Institute, France

Gustave Roussy, Cancer Campus, Grand Paris

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Irinotecan

Dexamethasone

Dexamethasone acetate

Floxuridine

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antimetabolites

Folate

Vitamin B9

Patients will receive Systemic CPT-11 + HAI (FUDR+L-OHP) every 28 days:

Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; followed by Oxaliplatin 85 mg/m2 over 3 hours through the HAI pump on Day 1 and 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

then Irinotecan 150 mg/m2 IV over 90 minutes on Day 15, followed by Oxaliplatin 85 mg/m2 IV over 3 hours on Day 15.

This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.

Patients will receive Systemic FOLFOXIRI every 28 days:

Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and Day 15; Oxaliplatin 85 mg/m2 IV in 3-6 hours on Day 1 and Day 15; Leucovorin 200mg/m2 and 5-FU 2400mg/m2 CIV in 46 hours on Day 1 and Day 15.

Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.

Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.

0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.

5-FU

Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.

Yuhong Li, MD

The aim of the trial is to compare the objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases. The patients will be treated with systemic FOLFOXIRI chemotherapy or FUDR/Oxaliplatin hepatic arterial infusion with CPT-11 systemic chemotherapy.

Previous studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. Hepatic arterial infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion oxaliplatin and FUDR could increase response rate and resection rate for colorectal liver metastasis. Therefore, we designed this study to compare objective response rates of FUDR/Oxaliplatin HAI plus CPT-11 and FOLFOXIRI chemotherapy in patients with initially non-resectable metastatic colorectal cancer liver metastases.

FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

FUDR/Oxaliplatin HAI Plus Irinotecan Chemotherapy vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

defined as complete remission rates and partial remission rates after treatment.

defined as no macroscopic or microscopic residual tumor

defined as the largest depth of tumor regression

defined as the period from the date of receiving treatment to disease progress caused by any reason.

defined as the period from the date of resection to tumor relapse caused by any reason.

defined as the period from the date of receiving treatment to death caused by any reason.

defined as the incidence and severity of adverse events related to chemotherapy, HAI and surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases	NCT02494973	Colorectal Canc...	Oxaliplatin HAI Oxaliplatin IV mFOLFOX6 LV5FU2	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM	NCT03678428	Metastatic Colo... Liver Metastase...	Irinotecan Oxaliplatin HAI Floxuridine Leucovorin 5-FU Oxaliplatin	18 Years - 70 Years	Sun Yat-sen University
Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases	NCT02494973	Colorectal Canc...	Oxaliplatin HAI Oxaliplatin IV mFOLFOX6 LV5FU2	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM	NCT03678428	Metastatic Colo... Liver Metastase...	Irinotecan Oxaliplatin HAI Floxuridine Leucovorin 5-FU Oxaliplatin	18 Years - 70 Years	Sun Yat-sen University

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