Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor
This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Children's Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379340
First received: September 19, 2006
Last updated: November 3, 2012
Last verified: November 2012
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Purpose
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Metastatic Cancer |
Biological: dactinomycin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Dactinomycin
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Etoposide phosphate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Event-free survival as measured by Woolson and an O'Brien-Fleming Boundary at 4 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed Wilms tumor meeting 1 of the following criteria:
- Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
- Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
- Patients must begin therapy within 14 days after surgery or biopsy (day 0), unless medically contraindicated
- Extra-pulmonary metastases include lymph node involvement in the hilum and/or mediastinum deemed by the treating institution to represent malignant disease, or positive cytology-proven pleural effusions
No bilateral Wilms tumors (stage IV)
- Patients should be referred to COG-AREN0534
- Previously enrolled in clinical trial COG-AREN03B2
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT < 2.5 times ULN
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532 OR treatment for emergent issues, as medically indicated
- No concurrent aprepitant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379340
Show 201 Study Locations
Show 201 Study LocationsSponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | David B. Dix, MD, FRCP, MBChB | Children's and Women's Hospital of British Columbia |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00379340 History of Changes |
| Other Study ID Numbers: | CDR0000496508, COG-AREN0533 |
| Study First Received: | September 19, 2006 |
| Last Updated: | November 3, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III Wilms tumor stage IV Wilms tumor lung metastases |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Wilms Tumor Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
Neoplastic Processes Pathologic Processes Neoplasms, Complex and Mixed Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Dactinomycin Doxorubicin Cyclophosphamide Etoposide Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013