Protocol Active Surveillance Small Renal Masses (SRMs)

Kidney Cancer Clinical Trial

Official title:

Sorveglianza Attiva Dei Tumori Renali T1a Uguali o Inferiori a 2 cm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03804320
• Other study ID #: Protocollo SRM Sorv Attiva
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2015
• Est. completion date: December 11, 2028

Study information

• Verified date: February 2020
• Source: IRCCS San Raffaele
• Contact: Cristina Carenzi
• Email: carenzi.cristina[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective study of active surveillance, non-randomized, multicentric, in asymptomatic patients over the age of 50 years, not affected by other tumors, with occasional diagnosis of single monolateral solid renal mass equal to or less than 2 cm of diameter. Diagnosis will be performed with chest CT abdomen with contrast and / or MRI abdomen with Gadolinium (Gd); during the first year of active surveillance, the patient's status will be evaluated at 3, 6, 9 and 12 months from the diagnosis and, subsequently, according to the schedule of events shown in the table "Event Planning" At the end of the 5 years of follow up, the patient will be entrusted to his / her own treating physician, with indication to perform abdomen and chest x-ray echography every 6 months and thoracic abdomen TAC with contrast and / or MRI abdomen with (Gd) every 2 years up to 10 years from instrumental radiological diagnosis and registration and communication of the possible date of death and cause The primary caregivers and the patient will be contacted annually by the promoter center of the study at the end of the first 5 years of study follow up and the data will be entered in the database by the promoter center. The indication to surgical treatment or ablative treatment will be considered in the following cases: 1. appearance of metastasis 2. increase of the maximum diameter of the renal mass equal to or greater than 4 cm 3. time of doubling of the tumor mass size less than or equal to 12 months 4. appearance of symptoms associated with renal disease (pain, haematuria) 5. appearance of paraneoplastic syndrome (fever, cachexia, hypercalcemia, polycythemia, ranulocytosis) 6. willingness expressed by the patient to undergo surgery or ablative operation In the presence of at least one of the aforementioned criteria, the attending physician can evaluate the possible execution of renal biopsy. The finding of renal biopsy proved negative for neoplasia may allow the continuation of the active surveillance procedure undertaken, independently indi - ding from the presence of one of the above mentioned criteria. If the renal biopsy is negative, the therapeutic decision (continuation of the follow up within the protocol in question, surgery or exit from the protocol) will be agreed between the patient and the patient. In the case of a positive renal biopsy for renal neoplasia, the patient may be a candidate for renal tumorectomy / radical nephrectomy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 11, 2028
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. ability to read, understand and interpret an informed consent;

2. voluntary subscription of the active surveillance protocol through written informed consent; 3) age over 50 years;

4) diagnosis of monolateral, monofocal, and first-rate solid renal mass less than 2 cm; 5) absence of symptoms due to renal tumor pathology.

Exclusion Criteria:

1. patients with a history of previous renal neoplasia;

2. monorenal patients;

3. patients with hereditary renal tumors (such as tuberous sclerosis and Von Hippel Lindau syndrome, etc.);

4. patients with metastasis;

5. patients suffering from immunodepressive diseases;

6. patients on concomitant therapy with chemotherapeutic agents or systemic immunosuppressants;

7. patients with life expectancy of less than 1 year.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Other:
• Active Surveillance

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (25)

Ayati M, Nikfallah A, Jabalameli P, Najjaran Tousi V, Noroozi M, Jamshidian H. Extensive surgical management for renal tumors with inferior vena cava thrombus. Urol J. 2006 Fall;3(4):212-5. — View Citation

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Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH, Faraday MM, Kaouk JH, Leveillee RJ, Matin SF, Russo P, Uzzo RG; Practice Guidelines Committee of the American Urological Association. Guideline for management of the clinical T1 renal mass. J Urol. 2009 Oct;182(4):1271-9. doi: 10.1016/j.juro.2009.07.004. Epub 2009 Aug 14. — View Citation

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Frank I, Blute ML, Cheville JC, Lohse CM, Weaver AL, Zincke H. Solid renal tumors: an analysis of pathological features related to tumor size. J Urol. 2003 Dec;170(6 Pt 1):2217-20. — View Citation

Hollingsworth JM, Miller DC, Daignault S, Hollenbeck BK. Rising incidence of small renal masses: a need to reassess treatment effect. J Natl Cancer Inst. 2006 Sep 20;98(18):1331-4. — View Citation

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134. — View Citation

Jewett MA, Mattar K, Basiuk J, Morash CG, Pautler SE, Siemens DR, Tanguay S, Rendon RA, Gleave ME, Drachenberg DE, Chow R, Chung H, Chin JL, Fleshner NE, Evans AJ, Gallie BL, Haider MA, Kachura JR, Kurban G, Fernandes K, Finelli A. Active surveillance of small renal masses: progression patterns of early stage kidney cancer. Eur Urol. 2011 Jul;60(1):39-44. doi: 10.1016/j.eururo.2011.03.030. Epub 2011 Apr 1. — View Citation

Klinghoffer Z, Tarride JE, Novara G, Ficarra V, Kapoor A, Shayegan B, Braga LH. Cost-utility analysis of radical nephrectomy versus partial nephrectomy in the management of small renal masses: Adjusting for the burden of ensuing chronic kidney disease. Can Urol Assoc J. 2013 Mar-Apr;7(3-4):108-13. doi: 10.5489/cuaj.502. — View Citation

Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184. — View Citation

Lane BR, Babineau D, Kattan MW, Novick AC, Gill IS, Zhou M, Weight CJ, Campbell SC. A preoperative prognostic nomogram for solid enhancing renal tumors 7 cm or less amenable to partial nephrectomy. J Urol. 2007 Aug;178(2):429-34. Epub 2007 Jun 11. — View Citation

Lane BR, Chen H, Morrow M, Anema JG, Kahnoski RJ. Increasing use of kidney sparing approaches for localized renal tumors in a community based health system: impact on renal functional outcomes. J Urol. 2011 Oct;186(4):1229-35. doi: 10.1016/j.juro.2011.05.081. Epub 2011 Aug 17. — View Citation

Mason RJ, Abdolell M, Trottier G, Pringle C, Lawen JG, Bell DG, Jewett MA, Klotz L, Rendon RA. Growth kinetics of renal masses: analysis of a prospective cohort of patients undergoing active surveillance. Eur Urol. 2011 May;59(5):863-7. doi: 10.1016/j.eururo.2011.02.023. Epub 2011 Feb 22. — View Citation

Nguyen MM, Gill IS. Effect of renal cancer size on the prevalence of metastasis at diagnosis and mortality. J Urol. 2009 Mar;181(3):1020-7; discussion 1027. doi: 10.1016/j.juro.2008.11.023. Epub 2009 Jan 16. — View Citation

Ozsoy M, Klatte T, Waldert M, Remzi M. Surveillance for the management of small renal masses. Adv Urol. 2008:196701. doi: 10.1155/2008/196701. — View Citation

Patel N, Cranston D, Akhtar MZ, George C, Jones A, Leiblich A, Protheroe A, Sullivan M. Active surveillance of small renal masses offers short-term oncological efficacy equivalent to radical and partial nephrectomy. BJU Int. 2012 Nov;110(9):1270-5. doi: 10.1111/j.1464-410X.2012.11130.x. Epub 2012 May 4. — View Citation

Raj GV, Thompson RH, Leibovich BC, Blute ML, Russo P, Kattan MW. Preoperative nomogram predicting 12-year probability of metastatic renal cancer. J Urol. 2008 Jun;179(6):2146-51; discussion 2151. doi: 10.1016/j.juro.2008.01.101. Epub 2008 Apr 18. — View Citation

Remzi M, Ozsoy M, Klingler HC, Susani M, Waldert M, Seitz C, Schmidbauer J, Marberger M. Are small renal tumors harmless? Analysis of histopathological features according to tumors 4 cm or less in diameter. J Urol. 2006 Sep;176(3):896-9. — View Citation

Smaldone MC, Kutikov A, Egleston BL, Canter DJ, Viterbo R, Chen DY, Jewett MA, Greenberg RE, Uzzo RG. Small renal masses progressing to metastases under active surveillance: a systematic review and pooled analysis. Cancer. 2012 Feb 15;118(4):997-1006. doi: 10.1002/cncr.26369. Epub 2011 Jul 15. Review. — View Citation

Tada S, Yamagishi J, Kobayashi H, Hata Y, Kobari T. The incidence of simple renal cyst by computed tomography. Clin Radiol. 1983 Jul;34(4):437-9. — View Citation

Thompson RH, Kaag M, Vickers A, Kundu S, Bernstein M, Lowrance W, Galvin D, Dalbagni G, Touijer K, Russo P. Contemporary use of partial nephrectomy at a tertiary care center in the United States. J Urol. 2009 Mar;181(3):993-7. doi: 10.1016/j.juro.2008.11.017. Epub 2009 Jan 16. — View Citation

Volpe A, Cadeddu JA, Cestari A, Gill IS, Jewett MA, Joniau S, Kirkali Z, Marberger M, Patard JJ, Staehler M, Uzzo RG. Contemporary management of small renal masses. Eur Urol. 2011 Sep;60(3):501-15. doi: 10.1016/j.eururo.2011.05.044. Epub 2011 Jun 1. Review. — View Citation

Volpe A, Panzarella T, Rendon RA, Haider MA, Kondylis FI, Jewett MA. The natural history of incidentally detected small renal masses. Cancer. 2004 Feb 15;100(4):738-45. — View Citation

Walther MM, Choyke PL, Glenn G, Lyne JC, Rayford W, Venzon D, Linehan WM. Renal cancer in families with hereditary renal cancer: prospective analysis of a tumor size threshold for renal parenchymal sparing surgery. J Urol. 1999 May;161(5):1475-9. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the therapeutic efficacy of active surveillance for small renal masses	Evaluate the therapeutic efficacy of active surveillance in patients with diagnosis of small renal tumor masses equal to or less than 2 cm in diameter.	10 years
Primary	Evaluate the proportion of patients who do not undergone active treatment	Proportion of patients who do not perform tumorectomy , tumor ablation or nephrectomy on the number of eligible patients that have been monitored for 12 months or more or have undergone surgery within 12 months	10 years
Secondary	Incidence and nature of disease progression during the period active surveillance	Determine the incidence and nature of disease progression during the period of active surveillance; determine the annual growth rate of SRMs equal to or less than 2 cm of diameter; evaluate the appearance of symptoms associated with the disease (pain, haematuria) or syndrome paraneoplasty (fever, cachexia, hypercalcemia, polycythemia, granulocytosis); establish possible factors clinical, pathological and biological predictive of local or metastatic disease progression or that require surgery.	10 years
Secondary	Evaluation of disease progression	The disease progression is defined as the growth of the maximum diameter of the renal mass equal to or more than 4 cm or doubling the tumor volume over a period of time = 12 months. It is considered sign of progression also the vascular invasion, with the appearance of thrombosis of the renal vein or of the inferior vena cava;	10 years