Clinical trial · Interventional
Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
Treatment of High Risk Renal Tumors: A Groupwide Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Renal Cell Carcinoma | Childhood Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Clear Cell Sarcoma of the Kidney | Clear Cell Sarcoma of the Kidney | ONTOLOGY_EXACT | 0.98 |
| Papillary Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Rhabdoid Tumor of the Kidney | Rhabdoid Tumor of the Kidney | ONTOLOGY_EXACT | 0.98 |
| Stage III Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage III Renal Wilms Tumor | Kidney Wilms Tumor |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dactinomycin | Biological | Dactinomycin | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Irinotecan Hydrochloride | Drug | Irinotecan | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Surgery
- description
- Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
- interventionNames
- Procedure: Conventional Surgery
- type
- EXPERIMENTAL
- label
- Treatment (UH-1)
- description
- Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
- interventionNames
- Drug: Doxorubicin Hydrochloride
- Procedure: Conventional Surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 29 Years
Show eligibility criteria text
Inclusion Criteria:
* Newly diagnosed disease of 1 of the following histologic types:
* Focal anaplastic Wilms' tumor
* Diffuse anaplastic Wilms' tumor
* Clear cell sarcoma of the kidney
* Malignant rhabdoid tumor (renal or extrarenal)
* Renal cell carcinoma
* Clear cell
* Papillary
* Renal medullary
* Oncocytoid
* Sarcomatoid
* Chromophobe
* Translocation
* Collecting duct
* Carcinoma associated with neuroblastoma
* Renal cell carcinoma unclassified
* Specimens/materials must be submitted for central review by Day 7
* Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
* Karnofsky performance status (PS) must be \>= 50 for patients \> 16 years if age and Lansky PS must be \>= 50 for patients =\< 16 years of age
* Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study
* Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ ALT\]) \< 2.5 times ULN for age
* Shortening fraction of \>= 27% by echocardiogram OR ejection fraction of \>= 50% by radionuclide angiogram
* Female patients of childbearing age must have a negative pregnancy test
* Female patients who are lactating must agree to stop breast-feeding
* Sexually active patients of childbearing potential must agree to use effective contraception
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be metReferences
Publications (1)
- DERIVEDBenedetti DJ, Renfro LA, Tfirn I, Daw NC, Kalapurakal JA, Ehrlich PF, Khanna G, Perlman E, Warwick A, Gow KW, Paulino AC, Seibel NL, Grundy P, Fernandez CV, Geller JI, Mullen EA, Dome JS. Treatment and outcomes of clear cell sarcoma of the kidney: A report from the Children's Oncology Group studies AREN0321 and AREN03B2. Cancer. 2024 Jul 1;130(13):2361-2371. doi: 10.1002/cncr.35266. Epub 2024 Feb 23. PMID 38396300