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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This study has been withdrawn prior to enrollment.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: October 10, 2014
Last verified: October 2014

November 18, 2009
October 10, 2014
July 2009
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01019278 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Undergo external proton beam radiation
  • Radiation: radiation therapy treatment planning/simulation
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
    • Neoplatin
    • PDD
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.
Interventions:
  • Radiation: proton beam radiation therapy
  • Radiation: radiation therapy treatment planning/simulation
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01019278
UPCC 22808, NCI-2009-01350
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Principal Investigator: Lillie Lin Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP