Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

NCT00334321 | Completed Phase 1 DMC

• 1 other identifier: 06-0297 / 201106410
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer

Keywords

IMRT; Tomotherapy; Post-Hysterectomy; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year from the start of radiation therapy.

Secondary Outcomes (4)

• Evaluate incidence of early toxicities

  30 days after last day of radiation therapy

• Evaluate incidence of late toxicities

  1 year from the start of radiation therapy

• Evaluate local, regional, and distant recurrence rates

  5 years from start of radiation therapy

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

  5 years from start of radiation therapy

Study Arms (1)

IMRT with chemotherapy

EXPERIMENTAL

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

Radiation: IMRT; Radiation: Intracavitary vaginal brachytherapy; Drug: Paclitaxel; Drug: Carboplatin

Interventions

IMRT RADIATION

IMRT with chemotherapy

Intracavitary vaginal brachytherapy RADIATION

IMRT with chemotherapy

Paclitaxel DRUG

Also known as: Taxol

IMRT with chemotherapy

Carboplatin DRUG

IMRT with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Perry W Grigsby, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2015
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

US (1)