Proton Beam Radiation Therapy and Cisplatin in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer and Positive Lymph Nodes
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.
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Radiation: proton beam radiation therapy
Radiation: radiation therapy treatment planning/simulation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Feasibility [ Designated as safety issue: No ]
- Acute toxicity, as assessed by NCI CTC Version 4.0 [ Time Frame: Within 60-90 days following completion of proton therapy ] [ Designated as safety issue: Yes ]
- Late toxicity, as assessed by RTOG/EORTC late morbidity scoring system [ Time Frame: More than 90 days after starting therapy ] [ Designated as safety issue: Yes ]
- Clinical efficacy (time to local failure, time to distant failure, overall survival) [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy.
Radiation: proton beam radiation therapy
Undergo external proton beam radiationRadiation: radiation therapy treatment planning/simulation Drug: cisplatin
I. To determine the feasibility of proton beam radiotherapy in patients with cervical cancer and FDG-positive para-aortic lymph nodes.
I. To determine the incidence of acute toxicity of concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic irradiation using proton radiotherapy with intracavitary brachytherapy in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
II. To assess late complications from irradiation using proton beam therapy in place of conventional photon beam therapy.
III. To compare the dose distribution to tumor and surrounding normal structures using DVHs (Dose Volume Histograms) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.
IV. To evaluate whether there is a benefit to concurrent weekly cisplatin chemotherapy in addition to pelvic and para-aortic proton beam radiotherapy with intracavitary brachytherapy as evidenced by time to local failure, time to distant failure, time to other failures and overall survival in patients with carcinoma of the uterine cervix with pelvic and para-aortic nodal involvement as demonstrated by FDG-PET.
Patients undergo CT, MRI, or FDG-PET imaging scans for radiotherapy treatment planning. Patients then undergo external proton beam radiotherapy once daily, 5 times per week, for up to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then annually for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019278
|United States, Pennsylvania|
|Abramson Cancer Center of The University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Lillie Lin||Abramson Cancer Center of the University of Pennsylvania|