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Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006027
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 22, 2020
National Cancer Institute (NCI)
Gynecologic Oncology Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
  • Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

  • Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
  • Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer
Study Start Date : August 2000
Actual Primary Completion Date : June 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:

    • Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
    • Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
  • No grade I adenocarcinoma
  • Less than 50% papillary serous or clear cell histology on pathologic specimen
  • Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
  • No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases



  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,800/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal


  • Creatinine no greater than 1.5 mg/dL


  • No cardiac dysrhythmias


  • No other malignancy within the past 5 years except nonmelanomatous skin cancer
  • No medical contraindications to study therapy


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006027

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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Gynecologic Oncology Group
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Study Chair: Kathryn M. Greven, MD Wake Forest University Health Sciences
Study Chair: Richard R. Barakat, MD Memorial Sloan Kettering Cancer Center
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Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00006027    
Other Study ID Numbers: RTOG-9905
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: August 2013
Keywords provided by Radiation Therapy Oncology Group:
stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial adenoacanthoma
endometrial clear cell carcinoma
endometrial papillary serous carcinoma
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action