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Clinical Trial to Assess the Importance of Nephrectomy (CARMENA)

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ClinicalTrials.gov Identifier: NCT00930033
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE June 30, 2009
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE September 9, 2009
Actual Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
The primary endpoint is overall survival. [ Time Frame: starting at 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2011)
  • Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria [ Time Frame: Starting at 4 months ]
  • Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ]
  • Progression-Free Survival [ Time Frame: Starting at 4 months ]
  • Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy [ Time Frame: Starting at 4 months ]
  • Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy [ Time Frame: Starting at 4 months ]
  • Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • Objective Response (complete or partial) is evaluated according to RECIST criteria [ Time Frame: Starting at 4 months ]
  • Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ]
  • Progression-Free Survival [ Time Frame: Starting at 4 months ]
  • Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy [ Time Frame: Starting at 4 months ]
  • Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy [ Time Frame: Starting at 4 months ]
  • Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ]
  • Tolerance is evaluated according to NCI-CTC v3. [ Time Frame: Starting at 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Assess the Importance of Nephrectomy
Official Title  ICMJE Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib
Brief Summary The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context
Detailed Description

The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell carcinoma have justified recommendation to initial nephrectomy for patients presenting with metastatic renal cell carcinoma. But these studies were performed at the time of immunotherapy.

The objective is Evaluation of the importance of nephrectomy in patients with metastatic renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be 50 mg daily with provision for dose reduction based on tolerability Patient will be treated until disease progression or unacceptable toxicity occurrence or withdraw.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Renal Cell Carcinoma
Intervention  ICMJE
  • Procedure: Nephrectomy
    Current surgery
  • Other: Sunitinib alone
    Sunitinib alone without nephrectomy
    Other Name: Sunitinib alone without nephrectomy
Study Arms  ICMJE
  • Active Comparator: A
    Nephrectomy + sunitinib
    Intervention: Procedure: Nephrectomy
  • Experimental: B
    Sunitinib alone
    Intervention: Other: Sunitinib alone
Publications *

*   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: November 6, 2017)
452
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)
576
Actual Study Completion Date  ICMJE October 22, 2018
Actual Primary Completion Date October 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age ≥ 18 years
  • ECOG Performance Status 0 - 1
  • Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
  • Documented metastatic disease
  • Absence of prior systemic treatment for kidney cancer including AA
  • Tumour amenable to nephrectomy (partial or total) in the opinion of the patient's urologist. Patients presenting with an inferior vena cava thrombosis can be included.
  • Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment.
  • Platelets > or = 100 x 109/L, haemoglobin >or = 9 g/dl, neutrophils >or = 1.5 x 109/L;
  • Bilirubin < or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)< or = 2.5 times the upper normal limit (UNL) or < or = 5 times UNL for patients with liver metastases
  • Patients of child bearing age should use contraceptive methods
  • Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
  • Life expectancy ≥ 3 months
  • Written informed consent
  • Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
  • Patient non treated by anticoagulants excepted HBPM

Exclusion Criteria:

  • Prior systemic treatment for kidney cancer (including Anti Angiogenic)
  • Bilateral kidney cancer
  • Pregnant or breast feeding women
  • Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis not treated with low molecular weight heparin or arterial thrombosis within the last 3 months
  • Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included)
  • Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
  • Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included)
  • Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib
  • Experimental treatment within the 28 days preceding inclusion
  • Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
  • Patient has received treatment with IV biphosphonate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, 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 NCT00930033
Other Study ID Numbers  ICMJE P070144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Arnaud Mejean, MD PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2021

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