Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer

• Status: Active, not recruiting
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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