Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases (PACHA-01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02494973|
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : July 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Oxaliplatin HAI Drug: Oxaliplatin IV Drug: mFOLFOX6 Drug: LV5FU2||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases - A Randomized Phase II/III Trial|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2028|
|Estimated Study Completion Date :||May 2028|
Active Comparator: Adjuvant systemic chemotherapy with mFOLFOX6
started within 8 weeks after surgery for a maximal duration of 6 months and at least 3 months, every 14 days:
Drug: Oxaliplatin IV
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.
Experimental: Adjuvant HAI oxaliplatin and systemic LV5FU2
started within 8 weeks after surgery for a maximal duration of 6 months and at least 3 months, and performed every 14 days:
Drug: Oxaliplatin HAI
Oxaliplatin 85 mg/m² in 2 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.
- 18-month hepatic RFS rate [ Time Frame: Assessed 18 months after inclusion ]
- 3-year RFS rate [ Time Frame: Assessed 3 years after inclusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494973
|Contact: Diane Goéré, MD||0142115441 ext +email@example.com|
|Contact: Jean Pierre Pignon, MD||0142114565 ext +firstname.lastname@example.org|
|Gustave Roussy Cancer Campus Grand Paris||Recruiting|
|Villejuif, Val De Marne, France, 94805|
|Contact: Diane Goéré, MD 0142115441 ext +33 diane.goéré@gustaveroussy.fr|
|Contact: Aurélie Abou Lovergne 0142113862 ext +33 email@example.com|
|Principal Investigator: Diane Goéré, MD|