Anemia Clinical Trial
Official title:
Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/l With Erythropoietin Versus Above 100 g/l Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.
OBJECTIVES:
Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with
epoetin alfa vs maintaining Hgb levels above 10.0 g/dL without epoetin alfa on
progression-free survival, overall survival, and local control in anemic patients with
cervical cancer receiving concurrent radiotherapy and cisplatin. Compare the quality of life
of patients treated with these regimens.
OUTLINE:
This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA),
method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes
(yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five
days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary
brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5
days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with
pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of
parametrial boost radiotherapy.
Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients
receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and
chemotherapy. Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of
last brachytherapy, and every 3 months for 2 years. Patients are followed every 3 months for
2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
| Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
| Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
| Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
| Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
| Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
| Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
| Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
| Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
| Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
| Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
| Completed |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 | |
| Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A |