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A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy

Primary Purpose

Cervical Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IMRT extended field external beam radiation therapy

Brachytherapy

Cisplatin

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring para-aortic lymph nodes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients must have carcinoma of the uterine cervix.
Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.
International Federation of Gynecology and Obstetrics (FIGO) Stage I to IVA
Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes), by PET.
Patients must have a Karnofsky Performance Status of >= 60 and no medical contraindications to the administration of chemotherapy.
Age >= 18.
Adequate bone marrow function: white blood cells (WBC) >= 4000/mm3, platelets >= 100,000 mm3.
Adequate renal function: BUN <= 25 mg/dl, creatinine <= 1.2 mg/dl (urinary diversion is permitted to improve renal function).
Patients must have bilirubin <= 1.5 mg/dl.
Signed study-specific informed consent.

Exclusion Criteria:

No positive lymph nodes by FDG PET
Positive supraclavicular lymph nodes by FDG PET Scan or evidence of more distant disease.
FIGO Stage IVB+ Cervical Cancer
No prior (within 5 years) or simultaneous malignancies (other than cutaneous basal cell carcinoma).
Karnofsky Performance Status <60.
Patients with significant medical illness preventing the use of full dose chemotherapy are excluded.
Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
Life expectancy < 6 months.
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL) are not eligible.
No prior surgery for treatment of disease other than exploratory laparotomy or biopsy.
No previous systemic chemotherapy.
No pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding.
Pregnant women are ineligible and those of child-bearing potential should practice contraception.
Patients with abnormal liver function tests

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment Group 1

Treatment Group 2

Arm Description

Pelvic Lymph Nodes Only Positive on FDG PET. IMRT External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin 40 mg/m^2

Para-Aortic Lymph Nodes Positive on FDG PET IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes) IMRT external beam pelvic radiation therapy as appropriate for stage Intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin (40 mg/m^2)

Outcomes

Primary Outcome Measures

Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)

Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status

Secondary Outcome Measures

Efficacy of IMRT to the Para-aortic Lymph Nodes, IMRT External Beam Radiotherapy to the Pelvis, Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by the Frequency of Distant Metastasis

Full Information

NCT ID

NCT00590967

First Posted

December 31, 2007

Last Updated

July 18, 2016

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00590967

Brief Title

A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy

Official Title

A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy With Concurrent Weekly Cisplatin in Patients With Stage I-IVA Cervical Cancer Who Have FDG PET Positive Pelvic or Para-Aortic Lymph Nodes

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Due to low accrual

Study Start Date

May 2003 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Recent studies have shown that the chance of survival among women with advanced cervical cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis. However, patients who have advanced disease show loco-regional failure as well as a high incidence of distant metastasis. Positron emission tomography (PET) scanning has high sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases. While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has been known to show positive lymph node metastasis in the pelvis only while not detecting micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are histologically known). In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more than 45 Gy) of radiation must be used to improve the probability of controlling the cancer. However, doses greater than this have been limited because of the dose and volume limits to the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has the improved ability to deliver large doses of radiation to specific targets while minimizing the exposure to surrounding normal tissue. With IMRT, however, the effective dose/volume can be increased more safely and lower the toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes not detected by PET safer and more effective.

Detailed Description

Prior to entrance on the study, patients will undergo a history and physical and evaluation of Karnofsky Performance Status. They will have a biopsy of their tumor and will undergo a fluorodeoxyglucose (FDG) PET scan and must include evaluation of para-aortic lymph nodes. Blood work will be done (complete blood count (CBC), differential, platelets, blood urea nitrogen(BUN), serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Also, pre-treatment, patients will receive a chest x-ray and an intravenous push (IVP) (unless a computed tomography (CT) with contrast has been performed). Additionally, patient may undergo a CT, magnetic resonance (MRI) and/or lymphangiogram. Patients will then be registered to a treatment arm, depending on the outcome of their PET scan. Patients with positive pelvic lymph nodes but no positive para-aortic lymph nodes by PET will be assigned to Treatment Arm 1. Patients with positive pelvic lymph nodes and positive para-aortic lymph nodes by PET will be assigned to treatment arm 2. Treatment Group 1. Either a conventional or CT simulation may be performed. Patients will be treated with IMRT extended field external beam radiation therapy (to cover pelvis and para-aortic lymph nodes) and intracavitary radiation (6 high dose radiation (HDR) treatments) concurrently with cisplatin (40 mg/m^2/week) Treatment Group 2. A CT simulation must be performed. Patients will be treated with extended field external beam radiation therapy to the pelvis and with IMRT to cover the para-aortic lymph nodes to 60 Gy, 50.4 Gy to the para-aortic lymph node bed in conjunction with external beam pelvic radiation therapy as appropriate for disease stage and intracavitary radiation (6 HDR treatments) concurrently with cisplatin (40 mg/m^2/week).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

para-aortic lymph nodes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group 1

Arm Type

Experimental

Arm Description

Pelvic Lymph Nodes Only Positive on FDG PET. IMRT External Beam radiation to the para-aortic region (45 Gy) Pelvis intracavitary brachytherapy (6 HDR treatments) Weekly cisplatin 40 mg/m^2

Arm Title

Treatment Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

IMRT extended field external beam radiation therapy

Intervention Type

Radiation

Intervention Name(s)

Brachytherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Primary Outcome Measure Information:

Title

Description

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

Time Frame

1 year post start of radiation therapy

Title

Time Frame

30 days after completion of radiation therapy

Title

Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status

Time Frame

1st PET scan after completion of treatment (approximately month 6)

Secondary Outcome Measure Information:

Title

Time Frame

5 years after completion of radiation therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must have carcinoma of the uterine cervix. Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible. International Federation of Gynecology and Obstetrics (FIGO) Stage I to IVA Patients must have no evidence of metastatic disease outside of the pelvis (except to the para-aortic nodes), by PET. Patients must have a Karnofsky Performance Status of >= 60 and no medical contraindications to the administration of chemotherapy. Age >= 18. Adequate bone marrow function: white blood cells (WBC) >= 4000/mm3, platelets >= 100,000 mm3. Adequate renal function: BUN <= 25 mg/dl, creatinine <= 1.2 mg/dl (urinary diversion is permitted to improve renal function). Patients must have bilirubin <= 1.5 mg/dl. Signed study-specific informed consent. Exclusion Criteria: No positive lymph nodes by FDG PET Positive supraclavicular lymph nodes by FDG PET Scan or evidence of more distant disease. FIGO Stage IVB+ Cervical Cancer No prior (within 5 years) or simultaneous malignancies (other than cutaneous basal cell carcinoma). Karnofsky Performance Status <60. Patients with significant medical illness preventing the use of full dose chemotherapy are excluded. Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic. Life expectancy < 6 months. Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL) are not eligible. No prior surgery for treatment of disease other than exploratory laparotomy or biopsy. No previous systemic chemotherapy. No pelvic radiation therapy is permitted other than transvaginal irradiation to control bleeding. Pregnant women are ineligible and those of child-bearing potential should practice contraception. Patients with abnormal liver function tests

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Perry Grigsby, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy

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