Cervical Cancer Clinical Trial
Official title:
A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes
Verified date | September 2016 |
Source | Abramson Cancer Center of the University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Specialized radiation therapy, such as proton beam radiotherapy, that delivers a
high dose of radiation directly to the tumor may kill more tumor cells and cause less damage
to normal tissue. Drugs used in chemotherapy, such as cisplatin, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving proton beam radiation therapy
together with cisplatin works in treating patients with stage IB, stage II, stage III, or
stage IVA cervical cancer and positive lymph nodes.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 18, 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion - Patients must have histologically documented carcinoma of the uterine cervix - FIGO Stage IB to IVA - Patients must have no distant metastases apart from positive lymph nodes by FDG PET - Patients must have a Karnofsky Performance Status of >= 60 - Treatment plan includes cisplatin and patient has no medical contraindications to the administration of cisplatin - Adequate bone marrow function: WBC >= 3000/mm^3; platelets >= 75,000 mm^3 - Adequate renal function: creatinine =< 2.0 mg/dl (urinary diversion is permitted to improve renal function) - Patients must have bilirubin =< 1.5 mg/dl - Ability to understand and the willingness to sign a written informed consent document Exclusion - FDG PET Scan evidence of distant disease - No prior surgery for treatment of disease other than exploratory laparotomy or biopsy will be allowed - No previous systemic chemotherapy will be allowed - No prior pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding will be allowed - Women of childbearing potential who have a positive result on screening serum pregnancy test |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center of the University of Pennsylvania |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility | |||
Primary | Acute toxicity, as assessed by NCI CTC Version 4.0 | Within 60-90 days following completion of proton therapy | ||
Secondary | Late toxicity, as assessed by RTOG/EORTC late morbidity scoring system | More than 90 days after starting therapy | ||
Secondary | Clinical efficacy (time to local failure, time to distant failure, overall survival) |
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