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A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) to the Pelvis ± Chemotherapy for Post-Operative Patients With Either Endometrial or Cervical Carcinoma

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Trial Conditions
  • Cervical Cancer
  • Endometrial Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Steward Physician(s)
  • Anuja Jhingran, MD
Trial Interventions
Drug
  • cisplatin
Radiation
  • intensity-modulated radiation therapy
Physician Researcher

Investigator Name:

  • Anuja Jhingran, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00331760
Volunteers:  Not Accepting Healthy Volunteers

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