Clinical trial · Interventional
Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix
Pilot Study of Adjuvant Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes
- 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)
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation. Proton beam radiation delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy which tends to unavoidably include more normal tissue along with tumor target tissue. In this research study, the investigators are looking to determine if proton beam radiation is effective in controlling your cancer growth. The investigators are also looking to see if proton beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Proton Radiation Therapy
- description
- This is a single arm study; all participants will receive proton radiation therapy.
- interventionNames
- Radiation: Proton radiation therapy
Primary outcomes (3)
- measure
- Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT)
- timeFrame
- 5 years
- description
- In a population of women with cancers of the cervix or endometrium with pathologically proven spread to regional lymph nodes, dose volume histograms (DVH) were compared between scanning proton beam teletherapy, 3-dimensional conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT). Structure sets contoured for the proton beam therapy delivered on study were used to plan alternative 3DCRT and IMRT plans by the the same medical physics team (3DCRT and IMRT were not used on study; actual dose for proton beam was compared to the doses that would have been delivered for 3DCRT or IMRT.) Median, 25th percentile, and 75th percentile doses are listed below by tissue volume irradiated (mL) or percentage irradiated (%) for each modality. Dose is measured in grays (Gy), which is defined as the absorption of one joule of radiation energy per kilogram of matter.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary cancer of the uterus or cervix with histologically confirmed metastasis to one or more parametrial, pelvic or paraaortic nodes prior to enrollment. Subjects diagnosed at other institutions must have pathology reviewed and confirmed at MGH or another DF/HCC institution * Have undergone simple, modified radical, or radical abdominal hysterectomy or vaginal hysterectomy and lymphadenectomy by open or laparoscopic assisted technique * Life expectancy greater than 18 months * Adequate organ and bone marrow function * Uterine cancer subjects will be FIGO stage IIIC and may have endometrioid cancer, clear cell cancer, uterine papillary serous cancer, carcinosarcoma, or endometrial stromal sarcoma * Cervical cancer subjects will be AJCC stages pT1,2,N1,M0 with squamous carcinoma, adenocarcinoma, adenosquamous carcinoma, or glassy cell carcinoma histology * ECOG performance status ≤ 2 or Karnofsky performance status ≥ 60% Exclusion Criteria: * Prior therapeutic radiation exposure to target tissues for protocol radiation * Evidence of extra-abdominal cancer dissemination or hematogenous cancer dissemination * Evidence of measurable residual disease following hysterectomy and lymphadenectomy * History of a different malignancy except if disease-free for at least 5 years and are deemed by the investigator ro be at low risk for recurrence of that malignancy. Subjects with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
References
Publications (0)
Data not yet available