Chemotherapy Toxicity On Quality of Life in Older Patients with Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-003141
- Scottsdale/Phoenix, Arizona: 12-003141
NCT ID: NCT01366183
Sponsor Protocol Number: GOG-0273
About this study
This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only
- International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible
- Patients must have received no previous treatment for this malignancy other than surgery
- Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
- Platelets greater than or equal to 100,000/mcl
- Bilirubin less than or equal upper limit of normal (ULN)
- Creatinine less than or equal to 1.5 x ULN
- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3
- Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)
- Patients must have recovered from the effects of recent surgery
- Patients must be free of active infection requiring antibiotics
- Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)
- Patient and physician agree that they plan to conduct treatment according to Regimen 3
- Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments
Exclusion Criteria:
- Patients who have received previous treatment for this malignancy other than surgery
- Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
- "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are excluded
- Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Andrea Wahner Hendrickson, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator John Camoriano, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available