Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

Proactive Management of Endoperitoneal Spread in Colonic Cancer (PROMENADE)

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: NCT02974556
Recruitment Status : Not yet recruiting
First Posted : November 28, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Sammartino, University of Roma La Sapienza

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Colon Cancer Intraperitoneal Rectal Cancer Procedure: Standard surgical treatment Procedure: Proactive management Drug: Standard adjuvant systemic chemotherapy Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Proactive Management of Endoperitoneal Spread in Colonic Cancer
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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.

Procedure: Standard surgical treatment
Standard surgical treatment (open or laparoscopic techniques) containing at least 12 lymph-nodes for accurate pN staging.

Drug: Standard adjuvant systemic chemotherapy
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:
  • adjuvant capecitabine and oxaliplatin (CAPOX)
  • adjuvant 5-FU and oxaliplatin (FOLFOX)

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.

Procedure: Proactive management
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.

Drug: Standard adjuvant systemic chemotherapy
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:
  • adjuvant capecitabine and oxaliplatin (CAPOX)
  • adjuvant 5-FU and oxaliplatin (FOLFOX)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: 3 years ]
  2. disease-free survival (DFS) [ Time Frame: 5 years ]
  3. overall survival (OS) [ Time Frame: 3 years ]
  4. overall survival (OS) [ Time Frame: 5 years ]
  5. extraperitoneal (systemic) or liver recurrence rate [ Time Frame: 3 years ]
  6. morbidity rate [ Time Frame: 1 month ]
  7. morbidity rate [ Time Frame: 6 months ]
  8. HIPEC toxicity rate [ Time Frame: 1 month ]
  9. HIPEC toxicity rate [ Time Frame: 6 month ]
  10. 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


  11. 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




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02974556


Contacts
Layout table for location contacts
Contact: Paolo Sammartino, MD PhD 336615632 ext +39 paolo.sammartino@uniroma1.it
Contact: Tommaso Cornali, MD 3489012376 ext +39 tommaso.cornali@uniroma1.it

Locations
Layout table for location information
Italy
ASST Nord Milano P.O. Città di Sesto S. Giovanni Not yet recruiting
Milano, PD, Italy, 35031
Contact: Gianandrea Baldazzi, MD       gbaldazzi@hotmail.com   
Principal Investigator: Gianandrea Baldazzi, MD         
Sub-Investigator: Diletta Cassini, MD         
ASO S. Croce e Carle Not yet recruiting
Cuneo, Italy, 12100
Contact: Felice Borghi, MD       borghi.f@ospedale.cuneo.it   
Principal Investigator: Felice Borghi, MD         
Sub-Investigator: Maria Carmela Giuffrida, MD         
Azienda Ospedaliera dei Colli
Napoli, Italy, 80131
Istituto Nazionale Tumori IRCCS Fondazione Pascale di Napoli
Napoli, Italy, 80131
Ospedale di Rimini Not yet recruiting
Rimini, Italy, 47923
Contact: Gianluca Garulli, MD       lucagarulli@gmail.com   
Principal Investigator: Gialuca Garulli, MD         
Sub-Investigator: Basilio Pirrera, MD         
University of Rome Sapienza Not yet recruiting
Roma, Italy, 00161
Contact: Paolo Sammartino, MD PhD    336615632 ext +39    paolo.sammartino@uniroma1.it   
Contact: Tommaso Cornali, MD    3489012376 ext +39    tommaso.cornali@uniroma1.it   
Principal Investigator: Paolo Sammartino, MD PhD         
Sub-Investigator: Tommaso Cornali, MD         
Sub-Investigator: Fabio Accarpio, MD PhD         
Sub-Investigator: Daniele Biacchi, MD Phd         
Ospedale Sant'Eugenio Not yet recruiting
Rome, Italy, 00144
Contact: Massimo Carlini, MD FACS       maxcarlini@tiscali.it   
Principal Investigator: Massimo Carlini, MD         
Sub-Investigator: Domenico Spoletini, MD         
Sub-Investigator: Daniela Apa, MD         
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy, 37126
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Layout table for investigator information
Principal Investigator: Paolo Sammartino, MD PhD University of Roma La Sapienza

Publications:
Layout table for additonal information
Responsible Party: Paolo Sammartino, Prof. Paolo Sammartino, MD Phd, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02974556     History of Changes
Other Study ID Numbers: PROMENADE v1.0
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents