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Clinical Trial to Assess the Importance of Nephrectomy (CARMENA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00930033
First received: June 29, 2009
Last updated: August 7, 2014
Last verified: July 2014

June 29, 2009
August 7, 2014
September 2009
September 2017   (final data collection date for primary outcome measure)
The primary endpoint is overall survival. [ Time Frame: starting at 4 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00930033 on ClinicalTrials.gov Archive Site
  • Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Progression-Free Survival [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Objective Response (complete or partial) is evaluated according to RECIST criteria [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Progression-Free Survival [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
  • Tolerance is evaluated according to NCI-CTC v3. [ Time Frame: Starting at 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Clinical Trial to Assess the Importance of Nephrectomy
Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Renal Cell Carcinoma
  • Procedure: Nephrectomy
    Current surgery
    Other Name: Nephrectomy
  • Other: Sunitinib alone
    Sunitinib alone without nephrectomy
    Other Name: Sunitinib alone without nephrectomy
  • Active Comparator: A
    Nephrectomy + sunitinib
    Intervention: Procedure: Nephrectomy
  • Experimental: B
    Sunitinib alone
    Intervention: Other: Sunitinib alone
León L, García-Figueras R, Suárez C, Arjonilla A, Puente J, Vargas B, Méndez Vidal MJ, Sebastiá C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
576
February 2018
September 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Arnaud Mejean, MD, PhD +33(0)1 44 49 53 36 arnaud.mejean@nck.aphp.fr
Contact: Laurence Lecomte, PhD +33(0)1 58 41 35 45 laurence.lecomte@cch.aphp.fr
France
 
NCT00930033
P070144
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Pfizer
Principal Investigator: Arnaud Mejean, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2014

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