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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer; Cervical Cancer

Treatments: Radiation: intensity-modulated radiation therapy; Drug: cisplatin

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00331760

RTOG-0418

CDR0000472905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Endometrial Cancer: IMRT

Other group

Description:

Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.

Treatment:

Radiation: intensity-modulated radiation therapy

Cervical Cancer: IMRT + Chemotherapy (cisplatin)

Other group

Description:

Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks and concurrent weekly cisplatin 40 mg/m\^2 for five weeks.

Treatment:

Radiation: intensity-modulated radiation therapy

Drug: cisplatin