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Trial record 1 of 1 for:    URGENCE PANCREAS
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Management of Symptomatic Advanced Pancreatic Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02979483
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group

Brief Summary:
This study assessed the feasibility and effects of an early integrative supportive care program in patient with Advanced pancreatic adenocarcinoma (aPDAC).

Condition or disease Intervention/treatment Phase
Pancreas Management Supportive Care Program Procedure: Integrative supportive care Not Applicable

Detailed Description:

Two-step cohort study:

* Step 1 : A 14-day integrative supportive care program initiated as early as the clinical suspicion of aPDAC.

According to the investigator's assessment of patient needs, this integrative supportive care program will include:

  • management of pain
  • nutritional support
  • pathologic diagnosis (endoscopy guides or percutaneous biopsies or ascitis cytology)
  • diagnostic computed imaging
  • endoscopic stenting of the bile duct and/or duodenum

    * Step 2 : Follow up after the integrative supportive care program. According to their Eastern Cooperative Oncology Group Performance Status(ECOG PS) and/or chemotherapy

  • Group 1 : Patient becoming eligible for treatment with FOLFIRINOX or nab-paclitaxel + gemcitabine and / or clinical trial
  • Group 2 :Patient at the end of the 14-day program (Step 1) remaining with either :

a - Persisting ECOG PS ≥ 2

b - Clinico-biological features that make them ineligible to receive the FOLFIRINOX or nab-paclitaxel + gemcitabine regimens

c - Patient ineligible to other therapeutic clinical trial


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Integrative Supportive Care
All planed procedures established during the first consultation with the investigator is successfully completed within the 14-day (+/-2 days)
Procedure: Integrative supportive care

At the inclusion, the investigator determine a personalized program of supportive care procedures for each patient (for instance : treatment of pain and nutritional support,stenting of bile duct and/or duodenum, tumor biopsy for pathologic diagnosis ,..)

At the end on the integrative supportive care, according to the ECOG-PS of patients , they will be classified into two groups:

  • Group 1 :Good prognosis - ECOG-PS 0-1 and eligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.

Patient will be treated by : FOLFIRINOX or gemcitabine-nab-paclitaxel or clinical trial

- Group 2 : Poor prognosis - ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.

Patients will be treated by: FOLFOX7lightened





Primary Outcome Measures :
  1. STEP 1 : Success rate (feasibility + clinical benefit) of the 14-day integrative supportive care program [ Time Frame: 14 days (+/- 2 days) ]
    Success of the integrative supportive care program following the first medical appointment in patients who have evocative symptom or pathologically confirmed symptomatic Advanced pancreatic adenocarcinoma (aPDAC)

  2. STEP 2 : 3-month Overall Survival rate [ Time Frame: Up to 3 months after the beginning of the chemotherapy ]

Secondary Outcome Measures :
  1. Delay from first symptom of aPDAC to first medical appointment [ Time Frame: Up to 2-3 months ]
  2. Delay from first medical appointment to beginning of chemotherapy [ Time Frame: Up to 1 month ]
  3. Rate of patients improvement of ECOG PS and clinico-biologic parameters [ Time Frame: Up to 14-day ]
    for biologic : livers tests, including bilirubin

  4. Rate of patients receiving chemotherapy [ Time Frame: At 14 days, at 21 days, Up to death ]
  5. Type of chemotherapy administered [ Time Frame: Up to 14 days ]
    type of chemotherapy : FOLFIRINOX, nab-paclitaxel + gemcitabine, gemcitabine alone, FOLFOX7 light or only best supportive care

  6. Rate of patients included in a clinical trial [ Time Frame: Up to 14 days ]
  7. Comparison score of Health-related quality of life (HRQoL) [ Time Frame: Between the score of HRQoL before the program and the score of HRQoL at the end of the 14 days program ]
  8. Rate of patient included in each group [ Time Frame: up to two years (after the recruitment of all patients) ]
  9. Progression free survival in each group [ Time Frame: up to two years ]
  10. Overall survival in each group [ Time Frame: up to two years ]
  11. Score of HRQoL (QLQ-C15 PAL) [ Time Frame: Month 1 and every two months up to two years ]


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

Inclusion Criteria - STEP 1:

  1. Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,
  2. Age ≥ 18 years,
  3. Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
  4. No prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer.
  5. Registration in France with the French National Health Care System (CMU included)
  6. Patient able to comply with study protocol requirements in the view of the investigator,
  7. Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
  8. Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).

Exclusion Criteria - STEP 1 :

  1. Any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
  2. Patient protected by law,
  3. Pregnant or breast feeding women

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): NCT02979483


Contacts
Contact: Benoît ROUSSEAU, MD benoit.rousseau@aphp.fr

Locations
France
Institut Sainte Catherine Not yet recruiting
Avignon, France
Contact: Philippe DEBOURDEAU, MD         
Principal Investigator: Philippe DEBOURDEAU, MD         
Hôpital Beaujon Not yet recruiting
Clichy, France
Contact: Pascal HAMMEL, MD         
Principal Investigator: Pascal HAMMEL, MD         
Hôpital Henri Mondor Recruiting
Créteil, France
Contact: Benoît ROUSSEAU, MD         
Principal Investigator: Benoît ROUSSEAU, MD         
Institut Hospitalier Franco-Britannique Recruiting
Levallois Perret, France
Contact: Aimery DE GRAMONT, MD         
Principal Investigator: Aimery DE GRAMONT, MD         
Centre Léon Bérard Not yet recruiting
Lyon, France
Contact: Christelle De la FOUCHARDIERE, MD         
Principal Investigator: Christelle de la FOUCHARDIERE, MD         
CH Layne Not yet recruiting
Mont de Marsan, France
Contact: Jérôme DAUBA, MD         
Principal Investigator: Jérôme DAUBA, MD         
Grope Hospitalier Paris Saint Joseph Recruiting
Paris, France
Contact: Eric RAYMOND, MD         
Principal Investigator: Eric RAYMOND, MD         
Hôpital Cochin Not yet recruiting
Paris, France
Contact: Romain CORIAT, MD         
Principal Investigator: Romain CORIAT, MD         
Hôpital Pitié Salpêtrière Recruiting
Paris, France
Contact: Jean Baptiste BACHET, MD         
Principal Investigator: Jean Baptiste BACHET, MD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France
Contact: Christophe LOUVET, MD         
Principal Investigator: Christophe LOUVET, MD         
Hopitaux du Léman Recruiting
Thonon les Bains, France
Contact: Ahmed BEDJAOUI, MD         
Principal Investigator: Ahmed BEDJAOUI, MD         
CHU Tours - Hôpital Trousseau Recruiting
Tours, France
Contact: Thierry LECOMTE, MD         
Principal Investigator: Thierry LECOMTE, MD         
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Principal Investigator: Benoît ROUSSEAU, MD CHU Henri Mondor Créteil

Responsible Party: GERCOR - Multidisciplinary Oncology Cooperative Group
ClinicalTrials.gov Identifier: NCT02979483     History of Changes
Other Study ID Numbers: Urgence Pancreas D16-1
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms