Kidney Cancer Clinical Trial
Official title:
SORCE: A Phase III Randomised Double-Blind Study Comparing Sorafenib With Placebo in Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after
surgery may kill any tumor cells that remain after surgery. It is not yet known whether
sorafenib is more effective than a placebo in treating kidney cancer.
PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works
compared with a placebo in treating patients at risk of relapse after undergoing surgery to
remove kidney cancer.
OBJECTIVES:
- Compare disease-free survival of patients with resected primary renal cell carcinoma at
high- or intermediate-risk of relapse treated with a placebo for 3 years vs a placebo
for 2 years and sorafenib tosylate for 1 year vs sorafenib tosylate for 3 years.
OUTLINE: This is a randomized, placebo-controlled, double-blind, open-label, multicenter
study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 3 years in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive oral sorafenib tosylate twice daily for 1 year and oral
placebo twice daily for 2 years in the absence of disease progression or unacceptable
toxicity.
- Arm III: Patients receive oral sorafenib tosylate twice daily for 3 years in the
absence of disease progression or unacceptable toxicity.
Patients in arms I and II with progressive disease may cross over and receive treatment in
arm III.
After completion of study treatment, patients are followed periodically.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00541008 -
Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
|
Phase 2 | |
| Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
| Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT03634540 -
A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003)
|
Phase 2 | |
| Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
| Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
| Completed |
NCT01048892 -
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features
|
Phase 1 | |
| Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Terminated |
NCT00896467 -
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy
|
N/A | |
| Recruiting |
NCT00301990 -
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00098943 -
NGR-TNF in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00467077 -
Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
| Terminated |
NCT00089102 -
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer
|
Phase 2 | |
| Terminated |
NCT00899860 -
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer
|
N/A | |
| Completed |
NCT00021021 -
RPI.4610 in Treating Patients With Metastatic Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00006968 -
Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 |