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Completed

NCT Number: NCT00334321

Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMRT

Radiation

Intracavitary vaginal brachytherapy

Radiation

paclitaxel

Drug

Other names: Taxol

carboplatin

Drug

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.

    Time frame: 1 year from the start of radiation therapy.

    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 outcomes

  1. Evaluate incidence of early toxicities

    Time frame: 30 days after last day of radiation therapy

  2. Evaluate incidence of late toxicities

    Time frame: 1 year from the start of radiation therapy

  3. Evaluate local, regional, and distant recurrence rates

    Time frame: 5 years from start of radiation therapy

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

    Time frame: 5 years from start of radiation therapy

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2015
First posted
Jun 7, 2006
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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