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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Procedure: Nephrectomy Other: Sunitinib alone Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib
Actual Study Start Date : September 9, 2009
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : October 22, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Nephrectomy + sunitinib
 Procedure: Nephrectomy
Current surgery
Experimental: B
Sunitinib alone
 Other: Sunitinib alone
Sunitinib alone without nephrectomy
Other Name: Sunitinib alone without nephrectomy


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is overall survival. [ Time Frame: starting at 4 months ]

Secondary Outcome Measures :
  1. Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria [ Time Frame: Starting at 4 months ]
  2. Clinical benefit (complete response, partial or stable for at least 12 weeks). [ Time Frame: Starting at 4 months ]
  3. Progression-Free Survival [ Time Frame: Starting at 4 months ]
  4. 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 ]
  5. 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 ]
  6. Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy [ Time Frame: Starting at 4 months ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT00930033


Locations
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France
Hopital Necker
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pfizer
Investigators
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Principal Investigator: Arnaud Mejean, MD PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00930033    
Other Study ID Numbers: P070144
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nephrectomy,
metastatic renal cell carcinoma,
sunitinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action