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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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01019278
First received: November 18, 2009
Last updated: March 21, 2012
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
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
Drug: cisplatin
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: July 2009
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 radiation
Radiation: radiation therapy treatment planning/simulation Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
  • Neoplatin
  • PDD

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019278

Locations
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Lillie Lin Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01019278     History of Changes
Other Study ID Numbers: UPCC 22808, NCI-2009-01350
Study First Received: November 18, 2009
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
 Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013