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Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

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ClinicalTrials.gov Identifier: NCT00334321
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: IMRT Radiation: Intracavitary vaginal brachytherapy Drug: Paclitaxel Drug: Carboplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
Study Start Date : April 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
Drug Information available for: Paclitaxel

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334321


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

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00334321     History of Changes
Other Study ID Numbers: 06-0297 / 201106410
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action