Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No cardiac dysrhythmias
Other:
- No other malignancy within the past 5 years except nonmelanomatous skin cancer
- No medical contraindications to study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Contacts and Locations
Show 29 Study Locations| Study Chair: | Kathryn M. Greven, MD | Comprehensive Cancer Center of Wake Forest University |
| Study Chair: | Richard R. Barakat, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006027 History of Changes |
| Other Study ID Numbers: | CDR0000068040, RTOG-9905, GOG-0194, RTOG-DEV-1047 |
| Study First Received: | July 5, 2000 |
| Last Updated: | April 30, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Neoplasms, Glandular and Epithelial Adjuvants, Immunologic Cisplatin Paclitaxel Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013