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Not yet recruitingNCT06032728Updated Sep 13, 2023

Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment

An interventional study of Sunitinib in Renal Cell Carcinoma, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
488
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group. Disease free survival and overall survival are the end points of observation.

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Conditions studied

  • Renal Cell Carcinoma

Keywords

  • target therapy
  • tyrosine kinase inhibitors (TKIs)
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In context

Carcinoma, Renal Cell

1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.

This study's planned enrollment of 488 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 161 studies on the registry; 54 are open to participants now.

Browse First Affiliated Hospital, Sun Yat-Sen University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The informed consent has been obtained from the patient.
  • With confirmed diagnosis of stage III clear cell renal cell carcinoma
  • With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
  • The patient receive no anti-cancer treatment before primary surgery.
  • The patient receive radical operation for renal cancer with negative margin.

Exclusion criteria

Exclusion Criteria:

  • Patients who have previously received neoadjuvant therapy
  • With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
  • With bad compliance or contraindication to enrollment.
  • Pregnant woman or lactating woman.
  • With contraindication to receive adjuvant targeted therapy.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
488 participants (estimated)

Study arms

  • Experimental
    A

    sunitinib 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.

    Drug: Sunitinib

  • No intervention
    B

    Patients with radical nephrectomy are observed without intervention

Interventions

  • DrugSunitinib

    The investigators randomly assign multimodal recurrence scoring system defined high risk patients of stage III ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation

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What researchers measure

Primary outcomes

  1. Disease free survival

    Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death.

    Time frame: From the date of registration to up to 10 years

Secondary outcomes

  1. Overall survival

    Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.

    Time frame: From the date of registration to up to 10 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2023; primary completion for Oct 2033, 120 months later.

Of 108 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 128. This study's planned 120 months is above that.

Counting every sponsor, half of 115 studies reached it within 48 months; a quarter within 21 and three quarters within 128.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2023
First posted
Sep 13, 2023
StartEst.
Oct 1, 2023
Primary completionEst.
Oct 1, 2033
CompletionEst.
Oct 1, 2033
Last update
Sep 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06032728
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Responsible party
Jun-Hang Luo (Professor, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Sep 13, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Oct 1, 2033 (estimated)
Completion
Oct 1, 2033 (estimated)
Last update
Sep 13, 2023

Study contacts

Jin-huan Wei, MD
Contact
342729243@qq.com
+8613580314021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Sunitinib

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