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
Condition: Cervical Cancer; Endometrial Cancer
MeSH terms: Uterine Cervical Neoplasms; Endometrial Neoplasms
Intervention: cisplatin; intensity-modulated radiation therapy
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      RATIONALE: Specialized radiation therapy (RT), such as intensity-modulated radiation therapy
      (IMRT), 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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Must have undergone a hysterectomy (total abdominal, vaginal, radical, or
             laparoscopic-assisted vaginal) within 7 weeks prior to study entry

               -  Patients with endometrial cancer must have also undergone a bilateral
                  salpingo-oophorectomy

          -  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)

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-2

          -  WBC (white blood cell count) ≥ 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 (aspartate aminotransferase) ≤ 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