Proton Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix

NCT01600040 | Completed Results DMC

• 1 other identifier: 10-269
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Uterine Cancer; Cervical Cancer

Keywords

metastatic

Outcome Measures

Primary Outcomes (3)

• Dosimetric Comparison of Proton Beam Treatment With 3-dimensional Conformal Radiation Therapy (3DCRT) and Intensity Modulated Radiation Therapy (IMRT)

  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.

  5 years

• Acute Radiation Side Effects

  Acute radiation side effects were prospectively assessed. Below are the treatment-related acute toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started within 4 weeks of treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).

  10 weeks

• Delayed Radiation Complications

  Delayed complications from radiation were prospectively assessed. Below are the treatment-related late toxicities (adverse events possibly, probably, or definitely related to protocol treatment that started 6 months or later after treatment completion) that occurred on study, along with the number of participants who experienced each event at a given severity (Grade 1/mild, Grade 2/moderate, Grade 3/severe) according to the CTCAE v 4.02 (Common terminology criteria for adverse events).

  5 years

Secondary Outcomes (2)

• Quality of Life (QOL)

  Baseline, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

• Progression-free Survival (PFS)

  12 months, 24 months, 36 months, 48 months, and 60 months

Study Arms (1)

Proton Radiation Therapy

OTHER

This is a single arm study; all participants will receive proton radiation therapy.

Radiation: Proton radiation therapy

Interventions

Proton radiation therapy RADIATION

5 days per week (Mon-Fri) for 5-6 weeks

Proton Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Uterine Neoplasms; Uterine Cervical Neoplasms; Neoplasm Metastasis

Interventions

Protons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Results Point of Contact

• Title: Andrea Russo, MD
• Organization: Massachusetts General Hospital

alrusso@mgh.harvard.edu

617-726-7941

Study Officials

• Andrea Russo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Gynecologic Radiation Oncology

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: August 1, 2013
• Primary Completion: October 19, 2022
• Study Completion: August 10, 2023
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Locations

US (1)