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Clear Cell Renal Cell CarcinomaPhase 2NCT01069770

Neoadjuvant Sunitinib Treatment for Metastatic Clear Cell Renal Cell Carcinoma (RCC)

A Phase 2 study testing Sunitinib in people with Clear Cell Renal Cell Carcinoma and Metastasis, run by Korean Urological Oncology Society at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces the size of the primary kidney tumor in patients with metastatic disease undergoing cytoreductive surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma, Metastasis
What is being tested?
Sunitinib
How many people
32 participants
Where
3 sitesSouth Korea
Study dates
Jul 2009to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven RCC with a component of clear cell type histology
  • Clinical stage TxNxM+
  • At least one site of measurable disease as defined by RECIST criteria
  • Potential candidates for cytoreductive nephrectomy
  • Favorable or intermittent risk group according to MSKCC risk factor model
  • ECOG performance status 0 or 1
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  • Adequate organ function as defined by:
  • AST or ALT less than or equal to 2.5 times the upper limit of normal
  • Bilirubin less than or equal to 1.5 times the upper limit of normal
  • Absolute neutrophil count (ANC) greater than or equal to 1500/mL
  • Platelets greater than or equal to 100,000/mL
  • Hemoglobin greater than or equal to 9.0 g/dL
  • Serum calcium less than or equal to 12.0 mg/dL
  • Serum creatinine less than or equal to 1.5 times the upper limit of normal
  • Male or female, 18 years of age or older
  • Women of childbearing potential must NOT be pregnant (as confirmed by a negative pregnancy test)
  • Signed informed consent form indicating that the patient or acceptable representative has been informed of all parts of the trial prior to Sunitinib administration (enrollment)
  • Willingness and ability to comply with study procedures

Who cannot join

  • History of another primary malignancy within 5 years, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
  • NCI CTCAE grade 3 hemorrhage within 4 weeks of commence of Sunitinib therapy.
  • Presence of brain metastases during screening period
  • Ongoing cardiac dysrhythmias of NCI CTCAE grade of 2 or more, atrial fibrillation of any grade or prolongation of QTc interval to more than 450 millisecond (msec) for male or more than 470 msec for female
  • Hypertension that cannot be controlled by medications
  • Concurrent treatment with therapeutic doses of coumadin but low dose of coumadin up to 2 mg orally daily for deep vein thrombosis prophylaxis is allowed.
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  • Current treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials are allowed.
  • Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea.
  • Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing before 7 and 12 days before date of randomization.
  • Other severe acute or chronic medical or psychiatric condition of laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
  • Any of the following within 12 months prior to study drug administration:
  • severe/unstable angina, myocardiac infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
  • Known hypersensitivity to Sunitinib
  • Women who are breast-feeding ※ Note At screening, resectability of primary tumor itself does not influence on patients enrollment. Physicians only have to describe about the resectability ("resectable" or "unresectable") at screening on their own discretion, but if they decide that primary tumor is "unresectable", the should specify reasons for unresectable status as follows: invasion into neighboring organs, proximity to vital structure or vessels, bulky regional lymph nodes, vascular invasion, burden of metastatic disease, and others.

Trial locations and contacts

3 sites in 1 country.

Jinsoo Chung, M.D.,Ph.D contact

+82-31-920-2456

cjs5225@ncc.re.kr

South Korea3 sites, 3 recruiting

  • Chungbuk University Hospital

    Cheonju, 361-711

    Wun-Jae Kim, M.D., Ph.D.

    Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

    Jinsoo Chung, M.D., Ph.D., +82-31-920-2456, cjs5225@ncc.re.kr

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul, 137-710

    Hyun Moo Lee, M.D.,Ph.D.

    Recruiting

Other trials in South Korea

About this study

Official title: Neoadjuvant Sunitinib Therapy in Patients With Metastatic Clear Cell Type Renal Cell Carcinoma Patients: a Prospective Study

The purpose of this study is to see whether neoadjuvant administration of Sunitinib reduces the size of the primary kidney tumor in patients with metastatic disease undergoing cytoreductive surgery. The study will also assess the safety of neoadjuvant Sunitinib, objective response rate, respectability of primary tumor, quality of life, and survival advantages.

Read the detailed description

Primary objectives :

  1. Response rate of primary tumor based on RECIST criteria

Secondary objectives :

  1. Resectability based on R0 resection rate (negative margin)
  2. Toxicities of therapy with neoadjuvant Sunitinib in renal cell carcinoma
  3. Quality of life assessed by EORTC QLQ-C30 questionnaire Korean version
  4. To assess the efficacy of neoadjuvant therapy of Sunitinib by evaluating time to progression
  5. Overall survival rate after Sunitinib therapy
  6. Pathologic evaluation after Sunitinib therapy: the change of necrosis and microvessel density
Being tested
Sunitinib
Keywords
Neoadjuvant Therapy, Sunitinib, Clear Cell Renal Cell Carcinoma, Metastasis
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SunitinibDrug

    Also called Sutent

    50mg daily(4 weeks on \& 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria

    Measured: within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off)

Secondary outcomes (4)

  1. Overall survival rate after Sunitinib therapy

    Measured: 2 years

  2. Pathologic evaluation after Sunitinib therapy

    Measured: After nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)

  3. Quality of life (QoL) assessed by EORTC QLQ-C30 questionnaire (Korean version)

    Measured: 2 years

  4. Resectability based on R0 resection rate

    Measured: on nephrectomy (within 1-6 week after 2 cycles of Sunitinib treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01069770
Sponsor's protocol ID
Sutent-IIR
Status last verified
Jun 2011
First submitted
12 Feb 2010
Last updated
23 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Clear Cell Renal Cell Carcinoma and Metastasis, run by Korean Urological Oncology Society at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinsoo Chung, M.D.,Ph.D (+82-31-920-2456, cjs5225@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of primary tumor based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria (time frame: within first 1 week (plus or minus 5 days) after 2 cycles of Sunitinib treatment (1 cycle: 4 weeks on + 2 weeks off)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01069770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.

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