Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00334321
First received: June 6, 2006
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Endometrial Cancer
Radiation: IMRT
Radiation: Intracavitary vaginal brachytherapy
Drug: Paclitaxel
Drug: Carboplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

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. [ Time Frame: 1 year from the start of radiation therapy. ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 30 days after last day of radiation therapy ] [ Designated as safety issue: Yes ]
  • Evaluate incidence of late toxicities [ Time Frame: 1 year from the start of radiation therapy ] [ Designated as safety issue: Yes ]
  • Evaluate local, regional, and distant recurrence rates [ Time Frame: 5 years from start of radiation therapy ] [ Designated as safety issue: No ]
  • Evaluate 5-year disease-free and 5-year overall survival rates [ Time Frame: 5 years from start of radiation therapy ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: April 2006
Estimated Study Completion Date: April 2015
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT with chemotherapy

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
Other Name: Taxol
Drug: Carboplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 18 years of age
  2. Karnofsky Performance Status of greater than or equal to 60
  3. FIGO Surgical Stage I, II, and III
  4. Pathologic confirmation of endometrial cancer
  5. Patient status post hysterectomy
  6. Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
  7. 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:

  1. Age less than 18 years of age
  2. Karnofsky Performance Status less than 60
  3. Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
  4. Prior pelvic radiation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334321

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Perry W Grigsby, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00334321     History of Changes
Other Study ID Numbers: 06-0297 / 201106410
Study First Received: June 6, 2006
Last Updated: December 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
IMRT
Tomotherapy
Post-Hysterectomy
Endometrial Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
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
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 23, 2014