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NCT00331760 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-02-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Percentage of Patients With Grade 2+ Bowel Adverse Events

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outcome · POSTED

Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events

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outcome · POSTED

Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events

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outcome · POSTED

Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant

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outcome · POSTED

Rate of Local-regional Failure at Five Years

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outcome · POSTED

Rate of Distant Metastases at Five Years

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outcome · POSTED

Rate of Disease-free Survival at Five Years

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outcome · POSTED

Rate of Overall Survival at Five Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT) 28 fractions over 5.5 weeks.
    intervention Names
    1. Radiation: intensity-modulated radiation therapy
    label
    Endometrial Cancer: IMRT
    type
    OTHER
  2. 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.
    intervention Names
    1. Drug: cisplatin
    2. Radiation: intensity-modulated radiation therapy
    label
    Cervical Cancer: IMRT + Chemotherapy (cisplatin)
    type
    OTHER
interventions
  1. arm Group Labels
    1. Cervical Cancer: IMRT + Chemotherapy (cisplatin)
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. Cervical Cancer: IMRT + Chemotherapy (cisplatin)
    2. Endometrial Cancer: IMRT
    name
    intensity-modulated radiation therapy
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
106
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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%.
    measure
    Reproducibility of Radiation Technique (Number of Unacceptable Deviations in Central IMRT Quality Assurance Review)
    time Frame
    IMRT planning and dosing data is centrally reviewed for quality assurance after treatment delivery.
secondary Outcomes
  1. description
    Bowel adverse events are defined as any of the following adverse events: diarrhea; enteritis; fistula; ileus:gastrointestinal (GI); incontinence:anal; necrosis:GI; obstruction:GI; perforation:GI; proctitis; stricture/stenosis (including anastomotic):GI. Adverse events are graded using Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event.
    measure
    Percentage of Patients With Grade 2+ Bowel Adverse Events
    time Frame
    From the start of treatment to 90 days.
  2. description
    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
    measure
    Percentage of Patients With Any Grade 3+ Treatment-related Adverse Events
    time Frame
    From start of treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
  3. description
    Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each adverse events (AE) based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Late is defined as more than 90 days after the start of radiation therapy.
    measure
    Percentage of Patients With Any Late Grade 3+ Treatment-related Adverse Events
    time Frame
    From 91 days after start of study treatment to the end of follow-up. Maximum follow-up at time of analysis was 10.2 years for endometrium cancer patients and 9.5 years for cervical cancer patients.
  4. description
    Chemotherapy treatment was centrally reviewed for quality assurance and compliance once complete chemotherapy treatment data was received from sites.
    measure
    Percentage of Cervical Carcinoma Patients That Were Chemotherapy Compliant
    time Frame
    From start to end of chemotherapy, approximately five weeks from registration.
  5. description
    Local-regional failure time is defined as time from registration to date of local-regional failure (any failure in the treatment field, which will be the pelvis only), death without local-regional failure (competing risk), or last known follow-up (censored). Local-regional failure rates are estimated by the cumulative incidence method.
    measure
    Rate of Local-regional Failure at Five Years
    time Frame
    From registration to five years.
  6. description
    Distant Metastases failure time is defined as time from registration to date of distant disease, death without distant metastases (competing risk), or last known follow-up (censored) and is estimated by the cumulative incidence method. Para-aortic nodal disease is considered to be distant disease for a cervical primary, but not for an endometrial primary.
    measure
    Rate of Distant Metastases at Five Years
    time Frame
    From registration to five years
  7. description
    Disease-free survival time is defined as time from registration to date of failure (any tumor recurrence, development of distant metastases or death from any cause) and is estimated by the Kaplan-Meier method. Patients last known to be alive without failure are censored at the date of last contact.
    measure
    Rate of Disease-free Survival at Five Years
    time Frame
    From registration five years
  8. description
    Overall survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
    measure
    Rate of Overall Survival at Five Years
    time Frame
    From randomization to five years
Full study description
brief 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.
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.
Source references
references
  1. citation
    Jhingran A, Winter K, Portelance L, Miller B, Salehpour M, Gaur R, Souhami L, Small W Jr, Berk L, Gaffney D. A phase II study of intensity modulated radiation therapy to the pelvis for postoperative patients with endometrial carcinoma: radiation therapy oncology group trial 0418. Int J Radiat Oncol Biol Phys. 2012 Sep 1;84(1):e23-8. doi: 10.1016/j.ijrobp.2012.02.044. Epub 2012 Apr 28.
    pmid
    22543211
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        ry.[<a href="#cit/section_7.40">40</a>-<a href="#cit/section_7.42">42</a>] A Radiation Therapy Oncology Group (RTOG) phase II trial (<a href="/clinicaltrials/NCT00331760">RTOG-0418</a> [NCT00331760]) evaluated the use of IMRT in patients with both cervical and endometrial cancers who require adjuvant radiation therapy. </p>
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        40">40</a>-<a href="#cit/section_7.42">42</a>] A Radiation Therapy Oncology Group (RTOG) phase II trial (<a href="/clinicaltrials/NCT00331760">RTOG-0418</a> [NCT00331760]) evaluated the use of IMRT in patients with both cervical and endometrial cancers who require adjuvant radiation therapy. </p> </section> </section
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      source title
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      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025

    Preserved source evidence · Not medical advice