Clinical Trial to Assess the Importance of Nephrectomy

NCT00930033 | Completed Phase 3 DMC

• 1 other identifier: P070144
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Nephrectomy,; metastatic renal cell carcinoma,; sunitinib

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is overall survival.

  starting at 4 months

Secondary Outcomes (6)

• Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria

  Starting at 4 months

• Clinical benefit (complete response, partial or stable for at least 12 weeks).

  Starting at 4 months

• Progression-Free Survival

  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

  Starting at 4 months

• Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy

  Starting at 4 months

Study Arms (2)

A

ACTIVE COMPARATOR

Nephrectomy + sunitinib

Procedure: Nephrectomy

B

EXPERIMENTAL

Sunitinib alone

Other: Sunitinib alone

Interventions

Nephrectomy PROCEDURE

Current surgery

A

Sunitinib alone OTHER

Sunitinib alone without nephrectomy

Also known as: Sunitinib alone without nephrectomy

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pfizer: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Necker

Paris, 75015, France

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nephrectomy; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Arnaud Mejean, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: September 9, 2009
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

FR (1)