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Endometrial CancerPhase 1NCT00334321

Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

A Phase 1 study testing IMRT, Intracavitary vaginal brachytherapy and Paclitaxel in people with Endometrial Cancer, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
IMRT, Intracavitary vaginal brachytherapy and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
Apr 2006to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study 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.

Being tested
IMRT, Intracavitary vaginal brachytherapy, Paclitaxel, Carboplatin
Keywords
IMRT, Tomotherapy, Post-Hysterectomy, Endometrial Cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00334321
Study groupRoleWhat they receive
IMRT with chemotherapyExperimentalIMRT (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
Receives: Radiation: IMRT; Radiation: Intracavitary vaginal brachytherapy; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year from the start of radiation therapy.

Secondary outcomes (4)

  1. Evaluate incidence of early toxicities

    Measured: 30 days after last day of radiation therapy

  2. Evaluate incidence of late toxicities

    Measured: 1 year from the start of radiation therapy

  3. Evaluate local, regional, and distant recurrence rates

    Measured: 5 years from start of radiation therapy

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

    Measured: 5 years from start of radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionApr 2011
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334321
Sponsor's protocol ID
06-0297 / 201106410
Status last verified
Oct 2015
First submitted
6 Jun 2006
Last updated
5 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMRT, Intracavitary vaginal brachytherapy and Paclitaxel in people with Endometrial Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.

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