Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

IMRT

Intracavitary vaginal brachytherapy

Paclitaxel

Carboplatin

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring IMRT, Tomotherapy, Post-Hysterectomy, Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age greater than or equal to 18 years of age Karnofsky Performance Status of greater than or equal to 60 FIGO Surgical Stage I, II, and III Pathologic confirmation of endometrial cancer Patient status post hysterectomy Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases Patients must have adequate: Bone Marrow Function: ANC ≥ 1,500/mcl (< CTCAE v 3.0 Grade 1). Platelets ≥ 100,000/mcl (< CTCAE v3.0 Grade 1). Renal Function: Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min. Hepatic Function: Bilirubin ≤ 1.5 x ULN (< CTCAE v 3.0 Grade 1). SGOT≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1). Alkaline phosphatase ≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1). Neurologic Function: Neuropathy (sensory and motor) < CTCAE v 3.0 Grade 1. Exclusion Criteria: Age less than 18 years of age Karnofsky Performance Status less than 60 Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes) Prior pelvic radiation therapy

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT with chemotherapy

Arm Description

IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks. Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician. Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles

Outcomes

Primary Outcome Measures

The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

The study will be deemed infeasible if greater than 10% of patients experience one of the following: Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence. Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.

Secondary Outcome Measures

Evaluate incidence of early toxicities

Evaluate incidence of late toxicities

Evaluate local, regional, and distant recurrence rates

Evaluate 5-year disease-free and 5-year overall survival rates

Full Information

NCT ID

NCT00334321

First Posted

June 6, 2006

Last Updated

October 1, 2015

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00334321

Brief Title

Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

Official Title

Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

IMRT, Tomotherapy, Post-Hysterectomy, Endometrial Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMRT with chemotherapy

Arm Type

Experimental

Arm Description

IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks. Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician. Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Type

Radiation

Intervention Name(s)

Intracavitary vaginal brachytherapy

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Primary Outcome Measure Information:

Title

The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

Description

The study will be deemed infeasible if greater than 10% of patients experience one of the following: Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence. Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.

Time Frame

1 year from the start of radiation therapy.

Secondary Outcome Measure Information:

Title

Evaluate incidence of early toxicities

Time Frame

30 days after last day of radiation therapy

Title

Evaluate incidence of late toxicities

Time Frame

1 year from the start of radiation therapy

Title

Evaluate local, regional, and distant recurrence rates

Time Frame

5 years from start of radiation therapy

Title

Evaluate 5-year disease-free and 5-year overall survival rates

Time Frame

5 years from start of radiation therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age greater than or equal to 18 years of age Karnofsky Performance Status of greater than or equal to 60 FIGO Surgical Stage I, II, and III Pathologic confirmation of endometrial cancer Patient status post hysterectomy Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases Patients must have adequate: Bone Marrow Function: ANC ≥ 1,500/mcl (< CTCAE v 3.0 Grade 1). Platelets ≥ 100,000/mcl (< CTCAE v3.0 Grade 1). Renal Function: Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine > ULN, a 24-hour creatinine clearance must be collected and must be > 50 mL/min. Hepatic Function: Bilirubin ≤ 1.5 x ULN (< CTCAE v 3.0 Grade 1). SGOT≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1). Alkaline phosphatase ≤ 2.5 x ULN (< CTCAE v 3.0 Grade 1). Neurologic Function: Neuropathy (sensory and motor) < CTCAE v 3.0 Grade 1. Exclusion Criteria: Age less than 18 years of age Karnofsky Performance Status less than 60 Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes) Prior pelvic radiation therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Perry W Grigsby, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Endometrial Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial