- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974556
Proactive Management of Endoperitoneal Spread in Colonic Cancer (PROMENADE)
This study aims to determine the oncological effectiveness, compared to standard surgical treatment, of proactive management including target organs for peritoneal spread resection (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v. 5-fluorouracil/leucovorin) following a curative resection of high-risk ( >/= 5 mm tumor invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens.
Hypothesis:
The hypothesis is that compared to the standard treatment proactive management following curative resection of high-risk T3 and T4 colon cancer will reduce the development of endoperitoneal metastases
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Paolo Sammartino, MD PhD
- Phone Number: +39 336615632
- Email: paolo.sammartino@uniroma1.it
Study Contact Backup
- Name: Tommaso Cornali, MD
- Email: tommaso.cornali@uniroma1.it
Study Locations
-
-
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Cuneo, Italy, 12100
- ASO S. Croce e Carle
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Contact:
- Felice Borghi, MD
- Email: borghi.f@ospedale.cuneo.it
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Principal Investigator:
- Felice Borghi, MD
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Sub-Investigator:
- Maria Carmela Giuffrida, MD
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Napoli, Italy, 80131
- Azienda Ospedaliera Dei Colli
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Napoli, Italy, 80131
- Istituto Nazionale Tumori IRCCS Fondazione Pascale di Napoli
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Rimini, Italy, 47923
- Ospedale di Rimini
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Principal Investigator:
- Gialuca Garulli, MD
-
Sub-Investigator:
- Basilio Pirrera, MD
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Roma, Italy, 00161
- University of Rome Sapienza
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Contact:
- Paolo Sammartino, MD PhD
- Phone Number: +39 336615632
- Email: paolo.sammartino@uniroma1.it
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Principal Investigator:
- Paolo Sammartino, MD PhD
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Sub-Investigator:
- Tommaso Cornali, MD
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Sub-Investigator:
- Fabio Accarpio, MD PhD
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Sub-Investigator:
- Daniele Biacchi, MD Phd
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Contact:
- Tommaso Cornali, MD
- Email: tommaso.cornali@uniroma1.it
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Rome, Italy, 00144
- Ospedale Sant'Eugenio
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Contact:
- Massimo Carlini, MD FACS
- Email: maxcarlini@tiscali.it
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Principal Investigator:
- Massimo Carlini, MD
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Sub-Investigator:
- Domenico Spoletini, MD
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Sub-Investigator:
- Daniela Apa, MD
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Verona, Italy, 37126
- Azienda Ospedaliera Universitaria Integrata Di Verona
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-
PD
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Milano, PD, Italy, 35031
- ASST Nord Milano P.O. Città di Sesto S. Giovanni
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Contact:
- Gianandrea Baldazzi, MD
- Email: gbaldazzi@hotmail.com
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Principal Investigator:
- Gianandrea Baldazzi, MD
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Sub-Investigator:
- Diletta Cassini, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with colon cancer or intraperitoneal rectosigmoid cancer with clinical (by CT) high-risk(> 5mm) T3, T4 tumors, any N, M0
- Performance Status (ECOG) 0, 1 or 2
- Signed informed consent
Exclusion Criteria:
- BMI> 30
- Impossibility of an adequate follow-up
- Intra and extraabdominal metastatic disease, multiple colorectal cancer or other malignancies
- Active infections or severe associated medical conditions (ASA IV or V)
- Abnormal bone marrow or renal and liver function indices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard surgical treatment group
Colon cancer patients (high-risk T3 and T4) without peritoneal or systemic metastases are resected for cure. Standard adjuvant systemic chemotherapy (FOLFOX or CAPOX regimens for 6 months) will be reserved in pT3 tumors with poor prognostic factors, pT4 tumor and if lymph-nodes metastases are present. Presence or absence of peritoneal recurrence will be evaluated by MDCT. |
Standard surgical treatment (open or laparoscopic techniques) containing at least 12 lymph-nodes for accurate pN staging.
Adjuvant systemic chemotherapy (according CAPOX or FOLFOX regimens for a total of 6 months) will be reserved in patients with pT3 tumors with poor prognostic factors, in patients with pT4 tumors and when lymph-nodes metastases are present.
Presence or absence of peritoneal recurrence will be evaluated by MDCT every six months for the first 24 months and later every year for the next three years in both study arms.
Other Names:
|
Experimental: Proactive management group
Colon cancer patients (high-risk T3 and T4) without peritoneal or systemic metastases are resected for cure. Simultaneously patients will undergo infracolic omentectomy, appendectomy, exeresis of the liver round ligament and, in women, a bilateral oophorectomy. At the end of surgical procedure HIPEC will be performed with oxaliplatin 460 mg/m2 and before the beginning of HIPEC an intravenous infusion of 400 mg/m2 of 5-FU and 20 mg/m2 of leucovorin will be administered. Standard adjuvant systemic chemotherapy (FOLFOX or CAPOX regimens for 6 months) will be reserved in pT3 tumors with poor prognostic factors, pT4 tumor and if lymph-nodes metastases are present. Presence or absence of peritoneal recurrence will be evaluated by MDCT. |
Adjuvant systemic chemotherapy (according CAPOX or FOLFOX regimens for a total of 6 months) will be reserved in patients with pT3 tumors with poor prognostic factors, in patients with pT4 tumors and when lymph-nodes metastases are present.
Presence or absence of peritoneal recurrence will be evaluated by MDCT every six months for the first 24 months and later every year for the next three years in both study arms.
Other Names:
Colon cancer patients (high-risk T3 and T4) without peritoneal or systemic metastases are resected for cure.
Simultaneously patients will undergo infracolic omentectomy, appendectomy, exeresis of the liver round ligament and, in women, a bilateral oophorectomy.
After positioning three in- and outflow catheters HIPEC perfusion starts with a minimum of 2 L isotonic dialysis fluid at a flow-rate of 1-2 l min and an inflow temperature of 42-43° C with a total of 30 minutes perfusion time.
Before the beginning of HIPEC 5-fluouracil and leucovorin will be administrated intravenously to potentiate oxaliplatin activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of endoperitoneal recurrence at 36 months
Time Frame: 36 months
|
The primary endpoint is the incidence of endoperitoneal recurrence at 36 months defined as the proportion of subjects with peritoneal metastases at 36 months from randomization.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIPEC toxicity rate
Time Frame: 1 month
|
1 month
|
|
HIPEC toxicity rate
Time Frame: 6 month
|
6 month
|
|
overall survival (OS)
Time Frame: 3 years
|
3 years
|
|
disease-free survival (DFS)
Time Frame: 3 years
|
3 years
|
|
disease-free survival (DFS)
Time Frame: 5 years
|
5 years
|
|
overall survival (OS)
Time Frame: 5 years
|
5 years
|
|
extraperitoneal (systemic) or liver recurrence rate
Time Frame: 3 years
|
3 years
|
|
morbidity rate
Time Frame: 1 month
|
1 month
|
|
morbidity rate
Time Frame: 6 months
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6 months
|
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EORTC QLQ-C30 Summary Score
Time Frame: 6 months
|
The EORTC QLQ-C30 Summary Score range from 0 to 100 and is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales need to be reversed to obtain a uniform direction of all scales. QLQ-C30 Summary Score = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 100-Fatigue+ 100-Pain+ 100-Nausea_Vomiting+ 100-Dyspnoea+ 100-Sleeping Disturbances+ 100-Appetite Loss+ 100-Constipation+ 100-Diarrhoea)/13 |
6 months
|
EORTC QLQ-C30 Summary Score
Time Frame: 1 year
|
The EORTC QLQ-C30 Summary Score range from 0 to 100 and is calculated from the mean of 13 of the 15 QLQ-C30 scales (the Global Quality of Life scale and the Financial Impact scale are not included). Prior to calculating the mean, the symptom scales need to be reversed to obtain a uniform direction of all scales. QLQ-C30 Summary Score = (Physical Functioning+ Role Functioning+ Social Functioning+ Emotional Functioning+ Cognitive Functioning+ 100-Fatigue+ 100-Pain+ 100-Nausea_Vomiting+ 100-Dyspnoea+ 100-Sleeping Disturbances+ 100-Appetite Loss+ 100-Constipation+ 100-Diarrhoea)/13 |
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sammartino P, Biacchi D, Cornali T, Cardi M, Accarpio F, Impagnatiello A, Sollazzo BM, Di Giorgio A. Proactive Management for Gastric, Colorectal and Appendiceal Malignancies: Preventing Peritoneal Metastases with Hyperthermic Intraperitoneal Chemotherapy (HIPEC). Indian J Surg Oncol. 2016 Jun;7(2):215-24. doi: 10.1007/s13193-016-0497-1. Epub 2016 Jan 26.
- Sammartino P, Sibio S, Biacchi D, Cardi M, Mingazzini P, Rosati MS, Cornali T, Sollazzo B, Atta JM, Di Giorgio A. Long-term results after proactive management for locoregional control in patients with colonic cancer at high risk of peritoneal metastases. Int J Colorectal Dis. 2014 Sep;29(9):1081-9. doi: 10.1007/s00384-014-1929-4. Epub 2014 Jul 1.
- Sammartino P, Sibio S, Accarpio F, Di Giorgio A. Prevention of peritoneal carcinomatosis from colorectal cancer: a critical issue. Ann Surg. 2014 Mar;259(3):e51. doi: 10.1097/SLA.0000000000000372. No abstract available.
- Sammartino P, Sibio S, Biacchi D, Cardi M, Accarpio F, Mingazzini P, Rosati MS, Cornali T, Di Giorgio A. Prevention of Peritoneal Metastases from Colon Cancer in High-Risk Patients: Preliminary Results of Surgery plus Prophylactic HIPEC. Gastroenterol Res Pract. 2012;2012:141585. doi: 10.1155/2012/141585. Epub 2012 May 8.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- PROMENADE v1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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