Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with radiation therapy. It is not yet known whether lerisetron is more effective than granisetron in preventing nausea and vomiting.

PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of granisetron in preventing nausea and vomiting in men who are being treated with radiation therapy for stage I seminoma.


Clinical Trial Description

OBJECTIVES: I. Compare the efficacy and safety of lerisetron versus granisetron hydrochloride in the prevention of radiotherapy induced nausea and vomiting in men with stage I testicular seminoma.

OUTLINE: This is a randomized, double blind, parallel, multicenter study. Patients are randomized to one of three treatment arms. Arm I: Patients receive oral lerisetron with an oral placebo once daily for 14 days. Arm II: Patients receive oral lerisetron once daily for 14 days. Arm III: Patients receive oral granisetron hydrochloride once daily for 14 days. At 1-2 hours following antiemetics, all patients undergo concurrent daily radiotherapy for at least 10 out of 14 days. Patients are followed daily for 10 days.

PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this study. ;


Study Design

Allocation: Randomized, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00004219
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 3

See also
  Status Clinical Trial Phase
Active, not recruiting 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Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is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
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 NCT00019331 - Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors Phase 2
Completed NCT00003107 - Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors Phase 1
Completed NCT00002515 - Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer Phase 2
Recruiting NCT00551122 - Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors Phase 1/Phase 2
Recruiting NCT00104676 - Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors Phase 3
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 NCT00324324 - Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant Phase 3
Completed NCT00045045 - Positron Emission Tomography in Detecting Testicle Cancer N/A
Completed NCT00003800 - Diagnostic Study of Patients With Stage I Testicular Cancer N/A
Completed NCT00004077 - Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer Phase 2
Active, not recruiting NCT00007813 - Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Phase 1
Terminated NCT00946283 - Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome N/A