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Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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Trial Information

Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma


OBJECTIVES:

- To determine if immediate versus deferred nephrectomy has an effect on disease control
in patients with resectable, synchronous, metastatic renal cell carcinoma treated with
sunitinib malate.

- To identify potential response criteria based on histopathology and molecular research
on tumor tissue.

OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance
status (0 vs 1), number of metastatic sites (1 vs 2 or more), and institution. Patients are
randomized to 1 of 2 treatment arms.

- Arm I (immediate nephrectomy): Patients undergo cytoreductive nephrectomy. Beginning 4
weeks after surgery, patients receive oral sunitinib malate once daily on days 1-28.
Treatment with sunitinib malate repeats every 6 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity.

- Arm II (deferred nephrectomy): Patients receive oral sunitinib malate once daily on
days 1-28. Treatment repeats every 6 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity. About 1 day after completion of sunitinib malate,
patients undergo cytoreductive nephrectomy. Patients then receive oral sunitinib malate
once daily on days 1-28. Treatment repeats every 6 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity.

Some patients undergo tumor tissue collection at baseline and at time of surgery to assess
possible differences in gene expression. Patients also undergo blood sample collection
periodically to evaluate the potential impact of serum proteins on the clinical outcome.
Samples are then stored for future studies.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell cancer (RCC)

- Clear-cell subtype with a resectable asymptomatic in situ primary

- Asymptomatic primary is defined as the absence of symptoms* which can be
exclusively assigned to the primary tumor such as flank pain and/or gross
hematuria necessitating blood transfusion NOTE: *Para-neoplastic symptoms
cannot be assigned to the primary tumor alone in metastatic disease, they
are not included in this definition.

- No symptomatic primary tumor necessitating nephrectomy

- Resectable primary tumor

- Bulky locoregional lymph node metastases larger than the primary tumor allowed
provided resectability of the lymph nodes is surgically feasible

- Metastatic RCC

- Distant metastases are not completely resectable at the time of surgery or
during an additional intervention

- No multiple distant lesions at one site

- No bone-only metastases

- Measurable disease, both primary and metastatic, according to RECIST 1.1 criteria

- Planning to receive sunitinib malate as background therapy

- Patients with > 3 of the following surgical risk factors are not eligible:

- Serum albumin CTCAE v 4.0 grade 2 or worse

- Serum LDH > 1.5 times upper limit of normal

- Liver metastases

- Symptoms at presentation due to metastases

- Retroperitoneal lymph node involvement

- Supra-diaphragmatic lymph node involvement

- Clinical stage T3 or T4 disease

- No clinical signs of CNS involvement

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- WHO performance status 0-1

- Life expectancy > 3 months

- WBC > 3.0 x 10^9/L

- Platelet count > 100 x 10^9/L

- Hemoglobin > 10.0 g/dL

- PT/PTT or INR ≤ 1.2 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver lesions)

- Serum calcium < 10.0 mg/dL

- Calculated or measured creatinine clearance > 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception 2 weeks before and during study
treatment

- LVEF normal by MUGA scan or ECHO

- 12-lead ECG normal

- No serious cardiac illness (myocardial infarction and/or treatable or untreatable
angina pectoris not responding to treatment) within the past 12 months

- No uncontrolled, high BP (≥ 150/100 mm Hg) despite optimal medical therapy

- No current pulmonary disease

- No active or uncontrolled infections, serious illnesses, malabsorption syndrome, or
medical conditions, including patients with a history of chronic alcohol abuse,
hepatitis, HIV, and/or cirrhosis

- No malignancies within the past 5 years except renal cell carcinoma, basal or
squamous cell carcinoma of the skin, carcinoma in situ of the cervix, resected
incidental prostate cancer staged pT2 with Gleason Score ≤ 6 and postoperative PSA <
0.5 ng/mL, or patients with any history of malignancies who are disease-free for more
than 5 years

- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

- Prior local radiotherapy for bone lesions allowed

- No prior systemic therapy for metastatic RCC

- No prior partial or total nephrectomy

- No concurrent systemic corticosteroid and/or other immunosuppressive systemic
therapies

- No concurrent radiotherapy, except palliative radiotherapy

- No concurrent participation in another clinical trial testing treatments for any
disease including renal cell carcinoma

- No other concurrent investigational or systemic therapy for metastatic RCC

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall progression-free survival

Safety Issue:

No

Principal Investigator

Axel Bex

Investigator Role:

Study Chair

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

Belgium: Ethics Committee

Study ID:

EORTC-30073

NCT ID:

NCT01099423

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

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