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Stereotactic Body Radiation Therapy (SABR) for Definitive Treatment of Locally Advanced Cervical Cancer

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Terminated
Phase 2

Conditions

Locally Advanced Cervical Cancer

Treatments

Radiation: SABR Boost Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02045433
STU 082013-064

Details and patient eligibility

About

The purpose of this study is to determine whether SABR boost therapy is effective in women with locally advanced cervical cancer without increased risk of acute gastrointestinal (GI) or genitourinary (GU) toxicity.

Full description

Patients enrolled in this study will receive 45 Gray (Gy) in 25 fractions of intensity modulated external beam radiation therapy + weekly cisplatinum . Following the completion of Intensity Modulated Radiation Therapy (IMRT), patients will receive 28 Gy in 4 fractions using stereotactic body radiation therapy techniques.

Enrollment

16 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1 Locally Advanced stage Cervical Cancer 2. Zubrod performance status 0-2 3. Negative urine or serum pregnancy test for women of child-bearing potential 4. Agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment 5. Not a candidate for intracavitary brachytherapy

Exclusion criteria

  1. Pregnancy
  2. Concurrent untreated cancer excluding non-Melanoma skin cancer
  3. Previous pelvic radiation
  4. Active Inflammatory Bowel disease, Collagen vascular disease - systemic lupus erythematosus (SLE), scleroderma
  5. Age <18
  6. Unable to consent for study
  7. Severely immunocompromised patients ( such as Transplant , on immunosuppressive drugs)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

SABR Boost Therapy
Experimental group
Treatment:
Radiation: SABR Boost Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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