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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV 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: NCT00005830
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 31, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Brief Summary:
Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer Drug: Doxorubicin Hydrochloride Drug: Cisplatin Radiation: Radiation Therapy Phase 1

Detailed Description:


I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer.

II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
Study Start Date : July 2000
Actual Primary Completion Date : July 2009

Arm Intervention/treatment
Experimental: Treatment (doxorubicin, cisplatin, radiation therapy)
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
Drug: Doxorubicin Hydrochloride
Given IV

Drug: Cisplatin
Given IV

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • RT

Primary Outcome Measures :
  1. Number of patients completing the prescribed therapy [ Time Frame: Up to 9 weeks ]
  2. Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0 [ Time Frame: 3 weeks ]
  3. Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0 [ Time Frame: Up to 5 years after completion of study treatment ]
  4. Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0 [ Time Frame: Up to 9 weeks ]

Secondary Outcome Measures :
  1. Reason for discontinuing study therapy [ Time Frame: Up to 9 weeks ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Histologically confirmed endometrial cancer including 1 of the following subtypes:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Endometrioid adenocarcinoma
  • Stage III or IV disease

    • Positive adnexa
    • Metastases to serosa, bowel mucosa, abdomen
    • Positive pelvic or paraaortic nodes
    • Positive pelvic washings or vaginal involvement within the radiation port
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry

    • Must have had a hysterectomy and bilateral salpingo oophorectomy
  • No recurrent disease
  • No distant metastases outside of abdominopelvic area, including:

    • Parenchymal liver metastases
    • Lung metastases
    • Positive inguinal lymph nodes
    • Positive supraclavicular nodes
    • Pleural effusion with malignant cytology
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and alkaline phosphatase no greater than 3 times ULN
  • Creatinine no greater than ULN
  • Cardiac ejection fraction greater than 50%
  • No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior chemotherapy
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for other prior malignancy

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): NCT00005830

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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Principal Investigator: Jeffrey Fowler Gynecologic Oncology Group
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Responsible Party: Gynecologic Oncology Group Identifier: NCT00005830    
Other Study ID Numbers: GOG-9908
NCI-2012-02332 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-9908 ( Other Identifier: Gynecologic Oncology Group )
GOG-9908 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Cystadenocarcinoma, Serous
Adenocarcinoma, Clear Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Cystic, Mucinous, and Serous
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action