Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Diagnostic procedures may improve a doctor's ability to predict the recurrence of testicular cancer. PURPOSE: Diagnostic trial to detect the risk of recurrent disease in patients who have stage I testicular cancer and who have undergone orchiectomy within the previous 12 weeks.


Clinical Trial Description

OBJECTIVES: - Use histopathological and immunohistological analysis of the primary testis tumor along with quantitative radiographic assessment to identify a subset of patients with clinical stage I nonseminomatous germ cell tumor of the testis who have a very low risk of metastasis. - Compare these findings with other predictive models of risk of metastasis after orchiectomy in this group of patients. OUTLINE: Patients undergo primary retroperitoneal lymph node dissection (RPLND) or active surveillance as management of their disease. The choice of treatment is determined by the physician and the patient. Patients with pathologically positive resected lymph nodes may undergo treatment (observation or adjuvant chemotherapy) at investigator's discretion. All patients are tested by quantitative radiology and blood markers (HCG and AFP) at baseline and then at various times after surgery to identify pathologic stage II disease. The timing of these studies depends on the stage of disease and/or type of disease management. Patients who undergo RPLND, have stage I or II disease, and do not receive adjuvant therapy (radiation or chemotherapy) are followed monthly during year 1, every 2 months during year 2, every 6 months during years 3-5, and annually thereafter. Patients who undergo RPLND, have stage II disease, and receive adjuvant therapy are followed every 2 months during year 1, every 4 months during year 2, every 6 months during years 3-5, and annually thereafter. Patients who do not undergo RPLND are followed monthly during year 1, every other month during year 2, every 6 months during years 3-5, and annually thereafter. PROJECTED ACCRUAL: A total of 315 patients will be accrued for this study within 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00003800
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase N/A
Start date November 16, 1999

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Completed NCT00002596 - Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Phase 3
Not yet recruiting NCT03448822 - Sentinel Lymph Node Procedure in Testicular Germ Cell Tumour
Completed NCT01433224 - Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression N/A
Recruiting NCT01172912 - High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy Phase 2
Completed NCT00293384 - Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant N/A
Active, not recruiting NCT00003643 - Combination Chemotherapy in Treating Men With Germ Cell Cancer Phase 2/Phase 3
Completed NCT00003107 - Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Phase 1
Completed NCT00019331 - Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors Phase 2
Completed NCT00002515 - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Phase 2
Recruiting NCT06133699 - Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors N/A
Recruiting NCT05670938 - Follow-up After Surgery for Testicular Cancer
Active, not recruiting NCT00104676 - Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Phase 3
Recruiting NCT00551122 - Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors Phase 1/Phase 2
Completed NCT00002508 - Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors Phase 1/Phase 2
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Completed NCT00007813 - Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Phase 1
Terminated NCT00324324 - Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant Phase 3