Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma
4 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2000
CompletedStudy Start
First participant enrolled
July 1, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedDecember 31, 2014
December 1, 2014
9 years
June 2, 2000
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Number of patients completing the prescribed therapy
Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Up to 5 years after completion of study treatment
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
Up to 9 weeks
Secondary Outcomes (1)
Reason for discontinuing study therapy
Up to 9 weeks
Study Arms (1)
Treatment (doxorubicin, cisplatin, radiation therapy)
EXPERIMENTALPatients 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.
Interventions
Undergo radiation therapy
Eligibility Criteria
You may qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Fowler
Gynecologic Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2000
First Posted
January 27, 2003
Study Start
July 1, 2000
Primary Completion
July 1, 2009
Last Updated
December 31, 2014
Record last verified: 2014-12