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Intensity-Modulated Radiation Therapy to the Pelvis With or Without Chemotherapy in Treating Patients With Endometrial Cancer or Cervical Cancer That Has Been Removed By Surgery
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331760
  Purpose

RATIONALE: Specialized radiation therapy, such as intensity-modulated radiation therapy, 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 intensity-modulated radiation therapy to the pelvis with or without chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy to the pelvis with or without chemotherapy works in treating patients with endometrial cancer or cervical cancer that has been removed by surgery.


Condition Intervention Phase
Cervical Cancer
Endometrial Cancer
Drug: cisplatin
Procedure: intensity-modulated radiation therapy
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Reproducibility of radiation technique [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade 2+ bowel adverse events (diarrhea, enteritis, fistula, ileus; gastrointestinal (GI), incontinence; anal, necrosis; GI, obstruction; GI, perforation; GI, proctitis and stricture/stenosis (including anastomotic); GI as graded by CTCAE v. 3.0) occ ... [ Designated as safety issue: Yes ]
  • All other adverse events [ Designated as safety issue: Yes ]
  • Chemotherapy compliance for cervical carcinoma patients [ Designated as safety issue: No ]
  • Local-regional failure [ Designated as safety issue: No ]
  • Distant metastases [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: March 2006
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the transportability of intensity modulated radiotherapy (IMRT) to a multi-institutional setting in patients with resected endometrial or cervical cancer.
  • Compare the efficacy, in terms of reducing short-term bowel injury, of IMRT versus standard treatments.
  • Assess adverse events related to this regimen.
  • Estimate the rates of local-regional control, distant metastasis, and disease-free and overall survival.
  • Evaluate chemotherapy compliance with this regimen for patients with cervical carcinoma.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (cervical vs endometrial cancer).

All patients undergo intensity modulated radiotherapy (IMRT) once a day, 5 days a week, for 5.5 weeks. Patients with cervical cancer also receive cisplatin IV over 30-60 minutes on day 1 or 2. Treatment with cisplatin repeats every 7 days for 5 courses (during radiotherapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 weeks post-IMRT and then every 3 months for 2 years, every 6 months for years 3-5, and then annually for at least 3 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Endometrial cancer meeting 1 of the following criteria:

      • Stage IB grade 3, IC grade 1-3, IIA, or IIB disease requiring postoperative pelvic radiotherapy
      • Unstaged (no lymph node dissection or sampling) stage IB grade 2 disease
      • Stage IIIC with all of the following:

        • Pelvic lymph node positive only
        • Para-aortic nodes sampled negative
        • Not receiving chemotherapy
    • Cervical cancer meeting 1 of the following criteria:

      • Post-radical hysterectomy and requires postoperative pelvic radiotherapy due to any of the following:

        • Positive pelvic nodes (negative para-aortic nodes)
        • Microscopic parametrial involvement and negative margins
        • Disease qualified by Sedlis criteria must have 2 of the following risk factors:

          • 1/3 or more stromal invasion
          • Lymph-vascular space invasion
          • Large clinical tumor diameter (≥ 4 cm)
      • Post-simple hysterectomy with negative margins and negative nodes by CT scan, MRI, or positron emission tomography-CT scan
  • No requirement for extended-field radiotherapy beyond the pelvis
  • No histologically confirmed papillary serous, clear cell, or neuroendocrine (either large or small cell) disease, endometrial stromal sarcoma, leiomyosarcoma, or malignant müllerian mixed tumor
  • No evidence of metastatic disease outside of the pelvis
  • No microscopic involvement of the resection margin (< 3 mm)
  • Must have undergone a hysterectomy (total abdominal, vaginal, radical, or laparoscopic-assisted vaginal) in the past 7 weeks

    • Patients with endometrial cancer must have also undergone a bilateral salpingo-oophorectomy

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • WBC ≥ 4,000/mm³ (cervical cancer patients only)
  • Absolute neutrophil count ≥ 1,800/mm³ (cervical cancer patients only)
  • Platelet count ≥ 100,000/mm³ (cervical cancer patients only)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Serum creatinine ≤ 2.0 mg/dL (cervical cancer patients only)
  • Creatinine clearance ≥ 50 mL/min (cervical cancer patients only)
  • AST ≤ 2 times upper limit of normal
  • Bilirubin ≤ 2 times upper limit of normal
  • Patients must not exceed the weight and size limits of the treatment table or CT scanner

    • No mental status changes or bladder control problems that would preclude study compliance with bladder-filling instructions
  • No active inflammatory bowel disease
  • No severe, active, concurrent illness, defined as any of the following:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • AIDS
  • No history of allergy to cisplatin (cervical cancer patients)
  • No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for ≥ 3 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
  • No prior platinum-based chemotherapy (cervical cancer patients)
  • No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or pegfilgrastim)
  • No concurrent prophylactic thrombopoietic agents
  • No concurrent amifostine or other protective agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331760

  Show 153 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Anuja Jhingran, MD M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000472905, RTOG-0418
Study First Received: May 30, 2006
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00331760  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma
endometrial adenoacanthoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Study placed in the following topic categories:
Squamous cell carcinoma
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Carcinoma
Genital Diseases, Female
Epidermoid carcinoma
Endometrial Neoplasms
Cisplatin
Carcinoma, squamous cell
Uterine Neoplasms
Endometrial cancer
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Adenosquamous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009