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

NCT ID: NCT01019278

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-08-18

Brief 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

Cervical Cancer; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

proton beam radiation therapy

Intervention Type: RADIATION

Undergo external proton beam radiation

radiation therapy treatment planning/simulation

Intervention Type: RADIATION

cisplatin

Intervention Type: DRUG

Given IV

Interventions

proton beam radiation therapy

Undergo external proton beam radiation

Intervention Type: RADIATION

radiation therapy treatment planning/simulation

Intervention Type: RADIATION

cisplatin

Given IV

Intervention Type: DRUG

Other Intervention Names

CACP; CDDP; CPDD; DDP; Neoplatin; PDD

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lillie Lin

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Other Identifiers

NCI-2009-01350

Identifier Type: -

Identifier Source: secondary_id

UPCC 22808

Identifier Type: -

Identifier Source: org_study_id