Trials / Withdrawn

WithdrawnNCT01019278

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

A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of proton beam radiotherapy in patients with cervical cancer and FDG-positive para-aortic lymph nodes. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

Interventions

Type	Name	Description
RADIATION	proton beam radiation therapy	Undergo external proton beam radiation
RADIATION	radiation therapy treatment planning/simulation
DRUG	cisplatin	Given IV

Timeline

Start date: 2009-07-01
Primary completion: 2011-08-01
Completion: 2011-08-18
First posted: 2009-11-24
Last updated: 2020-04-03

Source: ClinicalTrials.gov record NCT01019278. Inclusion in this directory is not an endorsement.