Summary

for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Loren Mell, MD

Description

Summary

The purpose of this study is to find out whether patients with cervical cancer treated with IMRT have less side effects with equal cancer control compared to standard radiation techniques. With standard radiation techniques, normal pelvic organs near the tumor receive radiation dose, which leads to side effects. IMRT is a new radiation technique that can reduce radiation dose to these organs and may reduce side effects. Compared to conventional RT techniques, the hypothesis is that IMRT will reduce acute hematologic and gastrointestinal toxicity for cervical cancer patients treated with concurrent cisplatin.

Official Title

Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

Details

Multiple randomized controlled trials have established concurrent cisplatin-based chemoradiotherapy as the standard of care for locally advanced cervical cancer [3-8]. The addition of concurrent cisplatin to radiotherapy (RT) increases pelvic control, disease-free survival (DFS) and overall survival; however, 5-year DFS and overall survival are still only approximately 60% and 5-year pelvic failure is approximately 30%. Moreover, acute gastrointestinal (GI) and hematologic toxicity are increased. Approximately 30% of patients will experience acute grade ≥ 3 toxicity, predominantly GI and hematologic. Methods to reduce toxicity during chemoradiotherapy, particularly gastrointestinal and hematologic, could mitigate this toxicity and take advantage of the therapeutic benefits of intensive concurrent chemotherapy.

Intensity modulated radiation therapy (IMRT) is a modern RT technique that differs from conventional techniques in many ways. First, patients undergo computed tomography (CT) simulation so that customized target volumes can be defined 3-dimensionally. IMRT treatment planning involves multiple beam angles and uses computerized inverse treatment planning optimization algorithms to identify dose distributions and intensity patterns that conform dose to the target, reducing radiation dose to surrounding tissues. IMRT delivery is typically accomplished with the use of multileaf collimators, which involve small motorized leaflets (collimators) that move in and out of the beam path, modulating the dose intensity.

Keywords

Cervical Cancer Cervical Carcinoma Cisplatin IMRT Radiation INTERTECC International External Beam Brachytherapy LDR HDR IGRT CBCT Uterine Cervical Neoplasms Intensity Modulated Radiation Therapy (IMRT)

Eligibility

You can join if…

Open to females ages 18 years and up

  • Biopsy-proven, invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
  • Biopsy result positive for carcinoma within 60 days prior to registration
  • FIGO clinical stage I-IVA disease, based on standard diagnostic workup, including:History/physical examination and/or Examination under anesthesia (if indicated)
  • If the patient is status post hysterectomy, one or more of the following conditions must be present: positive lymph nodes, positive margins, parametrial invasion, or non-radical surgery (i.e., simple hysterectomy).
  • If the patient is inoperable, one or more of the following conditions must be present: clinical stage IB2-IVA, positive lymph nodes on nodal sampling or frozen section, and/or parametrial invasion
  • Within 42 days prior to registration, the patient must have any of the following, if clinically indicated: examination under anesthesia, cystoscopy, sigmoidoscopy, rigid proctoscopy, or colonoscopy.
  • X-ray (PA and lateral), CT scan, or PET/CT scan of the chest within 42 days prior to registration;
  • CT scan, MRI, or PET/CT of the pelvis within 42 days prior to registration;
  • Karnofsky Performance Status 60-100
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; Platelets ≥ 100,000 cells/mm3;

Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable); Creatinine clearance ≥ 50 mg/dl; Bilirubin < 1.5 mg/dl; WBC ≥ 3,000/μl; ALT/AST < 3 x ULN; INR ≤ 1.5

  • Negative serum pregnancy test for women of child-bearing potential

You CAN'T join if...

  • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years;
  • Prior systemic chemotherapy within the past three years
  • Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation therapy fields;
  • Para-aortic, inguinal, or gross (unresected) pelvic nodal metastasis. Gross pelvic nodal metastasis is defined as either: Radiographic evidence of nodal metastasis on CT or MRI (node having short axis diameter > 1 cm)OR Radiographic evidence of nodal metastasis on diagnostic FDG-PET or PET/CT scan (abnormally increased FDG uptake as determined and documented by the radiologist)OR Biopsy-proven metastasis (e.g. needle biopsy) in undissected node
  • Distant metastasis
  • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Uncontrolled diabetes, defined as diabetes mellitus, which in the opinion of any of the patient's physicians requires an immediate change in management;
  • Uncompensated heart disease or uncontrolled high blood pressure
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition

Locations

  • Moores UC San Diego Cancer Center
    La Jolla California 92093 United States
  • University of Miami Miller School of Medicine
    Miami Florida 33136 United States

Lead Scientist

  • Loren Mell, MD
    Professor In Residence, Radiation Medicine and Applied Science. Authored (or co-authored) 122 research publications. Research interests: Personalized Medicine · Clinical Trials · Risk Modeling · Immune System · Imaging · Immunotherapy

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
Links
UC San Diego Department of Radiation Medicine & Applied Sciences
ID
NCT01554397
Phase
Phase 2/3
Study Type
Interventional
Last Updated