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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

Phase 2
18 Years
Open (Enrolling)
Cervical Cancer, Endometrial Cancer

Thank you

Trial Information

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


- 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

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

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

Inclusion Criteria


- 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

- 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

- 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)


- 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

- 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


- No history of allergy to cisplatin (cervical cancer patients)

- No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for
≥ 3 years


- See Disease Characteristics

- No prior radiotherapy to the pelvis that would result in overlap of radiotherapy

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)

Outcome Description:

Central quality assurance review of the IMRT planning and dosing categorized unacceptable deviations (UD) from protocol compliance with the delineation of planning target volume for the vagina and pelvic lymph nodes. Each arm of this study is considered independently, they are not compared to each other. The study was designed such that, for each arm, 5 or more of 42 subjects scored as unacceptable would determine the respective treatment technique as not reproducible. For each arm this design provides 90% power with a 0.05 type I error to reject the null hypothesis that the true probability of concluding the given technique to be reproducible is <= 80%. The alternative hypothesis is that the true probability is >= 95%. For [vagina / pelvic lymph nodes]: UD is defined as: The 90% isodose surface covers < 95% of [internal target volume (ITV)/ planned target volume (PTV)] 50.4 or > 5% of the [ITV/PTV] 50.4 receives over 115%.

Outcome Time Frame:

IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.

Safety Issue:


Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • 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
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Adenoma



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