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Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20) (Prodige20)

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ClinicalTrials.gov Identifier: NCT01900717
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE July 12, 2013
First Posted Date  ICMJE July 16, 2013
Last Update Posted Date December 27, 2018
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
Initial examination [ Time Frame: 21 days before the first course of treatment ]
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01900717 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2013)
Initial examination [ Time Frame: 14 days before inclusion ]
Medical history, clinical examination (HR, arterial blood pressure , temperature, weight, height, Eastern Cooperative Oncology Group performance status),
  • measurement of body surface area, ECG
  • completion of questionnaire by the patient (annexe 1),
  • completion of geriatric questionnaire "team" (annexe 2)
  • biological examination including:
    • full blood count-platelets
    • blood electrolyte panel, creatinemia
    • Albumin
    • ASAT, ALAT, PAL, GGT, total and conjugated bilirubin
    • CEA, CA 19.9, LDH markers
    • balanced INR for patients on AVK
    • Urinary dip with 24-hour proteinuria if > 1+
  • Measurement of creatinine clearance using the Cockcroft formula (in men: (140-age) x weight (kg)/0.814 x creatinemia (μmol), in women: (140-age) x weight (kg)/0.85 x creatinemia (μmol)),
  • In the absence of a cardiological examination in the year before or in the case of a history of severe cardiovascular disease: consultation in cardiology.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma (Prodige20)
Official Title  ICMJE Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
Brief Summary

To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.

This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Colorectal Adenocarcinoma
Intervention  ICMJE
  • Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
  • Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Study Arms  ICMJE
  • Active Comparator: chimiotherapy alone
    • LV5FU2 simplified,
    • 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified,
    • fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
    Intervention: Drug: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified
  • Experimental: chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
    • LV5FU2 simplified,
    • FOLFOX 4 simplified,
    • FOLFIRI modified.
    • Bevacizumab 5 mg/kg/ 2 weeks
    Intervention: Drug: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks
Publications * Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouché O, François E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2019 May 17. pii: gutjnl-2018-316407. doi: 10.1136/gutjnl-2018-316407. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2013)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 75 years or older
  • ECOG ≤2
  • histologically proven unresectable metastatic colorectal adenocarcinoma
  • Measurable lesion according to RECIST criteria
  • Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
  • Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
  • Completed geriatric self‐questionnaire
  • Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
  • Written informed consent

Exclusion Criteria:

  • Estimated life expectancy < 3 months
  • Non-resolved intestinal occlusion or sub‐occlusion
  • Cerebral metastasis
  • Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
  • Evolutive gastroduodenal ulcer, wound or bone fracture
  • Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
  • Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
  • Polynuclear neutrophils <1500/mm3, platelets <100 000/mm3 or 24-h proteinuria > 1g
  • History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
  • History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
  • History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
  • Impossibility to ensure regular follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01900717
Other Study ID Numbers  ICMJE Bedenne PHRC K 2010.
2010-022080-34 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP