NCT00930033 · CITED IN SOURCE DOCUMENTS

Clinical Trial to Assess the Importance of Nephrectomy

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2025-09-05

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nephrectomy + sunitinib
intervention Names
Procedure: Nephrectomy
label
A
type
ACTIVE_COMPARATOR
description
Sunitinib alone
intervention Names
Other: Sunitinib alone
label
B
type
EXPERIMENTAL

interventions

arm Group Labels
A
description
Current surgery
name
Nephrectomy
type
PROCEDURE
arm Group Labels
B
description
Sunitinib alone without nephrectomy
name
Sunitinib alone
other Names
Sunitinib alone without nephrectomy
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 452
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
The primary endpoint is overall survival.
time Frame
starting at 4 months

secondary Outcomes

measure
Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria
time Frame
Starting at 4 months
measure
Clinical benefit (complete response, partial or stable for at least 12 weeks).
time Frame
Starting at 4 months
measure
Progression-Free Survival
time Frame
Starting at 4 months
measure
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
measure
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
measure
Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy
time Frame
Starting at 4 months

Full study description

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.

Source references

references

citation
Mejean A, Ravaud A, Thezenas S, Chevreau C, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Oudard S, Laguerre B, Gross-Goupil M, Bernhard JC, Colas S, Albiges L, Lebret T, Treluyer JM, Timsit MO, Escudier B. Sunitinib Alone or After Nephrectomy for Patients with Metastatic Renal Cell Carcinoma: Is There Still a Role for Cytoreductive Nephrectomy? Eur Urol. 2021 Oct;80(4):417-424. doi: 10.1016/j.eururo.2021.06.009. Epub 2021 Jun 27.
pmid
34187771
type
RESULT
citation
Mejean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Beisland C, Aitchison M, Oudard S, Patard JJ, Theodore C, Chevreau C, Laguerre B, Hubert J, Gross-Goupil M, Bernhard JC, Albiges L, Timsit MO, Lebret T, Escudier B. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018 Aug 2;379(5):417-427. doi: 10.1056/NEJMoa1803675. Epub 2018 Jun 3.
pmid
29860937
type
RESULT
citation
Leon L, Garcia-Figueiras R, Suarez C, Arjonilla A, Puente J, Vargas B, Mendez Vidal MJ, Sebastia 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.
pmid
24338498
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-7ad944f6deaf1f5cd6122126
edge id
nct-edge-ae8e4fc2a72124e86397
requested nct id
NCT00930033
primary nct id
NCT00930033
source kind
nci_explicit_reference_or_link
source url
https://www.cancer.gov/types/kidney/hp/kidney-treatment-pdq
source record id
Source null
source file sha256
1f3a60c8c3de7fa1d487ba1b77058d98fb5f43d894314870b86ed48ec1e2ee61
payload sha256
b9d9381b7a039c7e67f261ec2ef9fdbb40215a22b1650c305d60f2f66d4ffb0c
payload
clinical indication matching status
not_inferred
end exclusive
true
id
nct-edge-ae8e4fc2a72124e86397
link basis
explicit_NCT_identifier_in_acquired_source
nct id
NCT00930033
occurrences
context exact
d studies suggest a benefit in good-risk patients in the current era of targeted therapies.</p> <p id="_461" tabindex="-1">The <a href="/clinicaltrials/NCT00930033">CARMENA</a> trial (NCT00930033) evaluated the effectiveness of cytoreductive nephrectomy before targeted therapy. The study reported no benefit for patients w
end
108023
exact text
NCT00930033
start
108012
context exact
ood-risk patients in the current era of targeted therapies.</p> <p id="_461" tabindex="-1">The <a href="/clinicaltrials/NCT00930033">CARMENA</a> trial (NCT00930033) evaluated the effectiveness of cytoreductive nephrectomy before targeted therapy. The study reported no benefit for patients who underwent cytoreductive nephr
end
108055
exact text
NCT00930033
start
108044
offset unit
unicode_code_points
source file
/tmp/cancer-full-research/nci/raw/4b032ee13ec68d6105.html
source file sha256
1f3a60c8c3de7fa1d487ba1b77058d98fb5f43d894314870b86ed48ec1e2ee61
source json pointer
Source null
source kind
nci_explicit_reference_or_link
source record id
Source null
source retrieved at
2026-09-09T23:21:50.909484+00:00
source string basis
UTF-8_text_with_universal_newline_translation
source string sha256
0166037cd1d0239345071d51a8ce6e03e41ba5c68717b24b550be4043d37cae6
source title
Renal Cell Cancer Treatment (PDQ®)–Health Professional Version
source update dates
context
Updated: May 13, 2025
datetime
2025-05-13T12:00:00Z
display
May 13, 2025
source url
https://www.cancer.gov/types/kidney/hp/kidney-treatment-pdq

Preserved source evidence · Not medical advice