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

NCT00590967 | Terminated Phase 2 Results

• 1 other identifier: 03-0300 / 201105362
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

para-aortic lymph nodes

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year post start of radiation therapy

• 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)

  30 days after completion of radiation therapy

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

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

Secondary Outcomes (1)

• 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

  5 years after completion of radiation therapy

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

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

Radiation: IMRT extended field external beam radiation therapy; Radiation: Brachytherapy; Drug: Cisplatin

Treatment Group 2

EXPERIMENTAL

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)

Radiation: IMRT extended field external beam radiation therapy; Radiation: Brachytherapy; Drug: Cisplatin

Interventions

IMRT extended field external beam radiation therapy RADIATION

Treatment Group 1; Treatment Group 2

Brachytherapy RADIATION

Treatment Group 1; Treatment Group 2

Cisplatin DRUG

Treatment Group 1; Treatment Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Perry Grigsby, M.D.
• Organization: Washington University School of Medicine

grigsby@radonc.wustl.edu

314-362-8502

Study Officials

• Perry Grigsby, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2007
• First Posted: January 11, 2008
• Study Start: May 1, 2003
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 29, 2016
• Results First Posted: August 29, 2016

Record last verified: 2016-06

Locations

US (1)