Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vaginal Cuff Brachytherapy
|
Radiation: Vaginal Cuff Brachytherapy
Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Progression-free Survival at 2 Years [2 years]
Secondary Outcome Measures
- Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
All patients must have undergone specified complete surgical staging.
-
Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
-
Patients must have adequate bone marrow, renal and hepatic function.
Exclusion Criteria:
-
Patients with recurrent disease.
-
Patients with GOG performance status of 3 or 4.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
Sponsors and Collaborators
- University of Oklahoma
Investigators
- Principal Investigator: Scott McMeekin, MD, University of Oklahoma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1524
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vaginal Cuff Brachytherapy |
|---|---|
| Arm/Group Description | Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk) |
| Period Title: Overall Study | |
| STARTED | 23 |
| COMPLETED | 21 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Vaginal Cuff Brachytherapy |
|---|---|
| Arm/Group Description | Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk) |
| Overall Participants | 23 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
6
26.1%
|
| >=65 years |
17
73.9%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
69
|
| Sex: Female, Male (Count of Participants) | |
| Female |
23
100%
|
| Male |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
23
100%
|
Outcome Measures
| Title | Number of Patients With Progression-free Survival at 2 Years |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vaginal Cuff Brachytherapy |
|---|---|
| Arm/Group Description | Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk) |
| Measure Participants | 23 |
| Count of Participants [Participants] |
19
82.6%
|
| Title | Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy |
|---|---|
| Description | |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vaginal Cuff Brachytherapy |
|---|---|
| Arm/Group Description | Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk) |
| Measure Participants | 23 |
| Count of Participants [Participants] |
23
100%
|
Adverse Events
| Time Frame | 2 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Vaginal Cuff Brachytherapy | |
| Arm/Group Description | Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk) | |
All Cause Mortality |
||
| Vaginal Cuff Brachytherapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | |
Serious Adverse Events |
||
| Vaginal Cuff Brachytherapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/23 (4.3%) | |
| Blood and lymphatic system disorders | ||
| neutropenic fever | 1/23 (4.3%) | 1 |
| Gastrointestinal disorders | ||
| Gastrointestinal bleed | 1/23 (4.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary Embolism | 1/23 (4.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Vaginal Cuff Brachytherapy | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/23 (4.3%) | |
| General disorders | ||
| Grade 4 Fatigue | 1/23 (4.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lisa Landrum, MD |
|---|---|
| Organization | University of Oklahoma |
| Phone | 405 271-8001 |
| lisa-landrum@ouhsc.edu |
- 1524