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Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib

Phase 3
18 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib

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

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.

Inclusion Criteria:

- age ≥ 18 years

- ECOG Performance Status 0 - 1

- Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell

- 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

- 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

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 (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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is overall survival.

Outcome Time Frame:

starting at 4 months

Safety Issue:


Principal Investigator

Arnaud Mejean, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

September 2009

Completion Date:

May 2016

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Nephrectomy,
  • metastatic renal cell carcinoma,
  • sunitinib
  • Carcinoma
  • Carcinoma, Renal Cell