Clinical trial · Interventional
Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
NCT00334321CI-TRIAL-00019327completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| IMRT | Radiation | — | UNRESOLVED |
| Intracavitary vaginal brachytherapy | Radiation | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT with chemotherapy
- description
- 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
- interventionNames
- Radiation: IMRT
- Radiation: Intracavitary vaginal brachytherapy
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
- timeFrame
- 1 year from the start of radiation therapy.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.