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

Phase 2/Phase 3
18 Years
Open (Enrolling)
Cervical Cancer

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Trial Information

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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

To test whether IMRT will reduce the rate of acute grade ≥ 3 hematologic or clinically significant grade ≥ 2 gastrointestinal toxicity compared to conventional RT techniques for cervical cancer patients treated with concurrent cisplatin

Outcome Time Frame:

Up to 10 weeks while on Treatment

Safety Issue:


Principal Investigator

Loren Mell, MD

Investigator Role:

Study Director

Investigator Affiliation:

University of California, San Diego


United States: Institutional Review Board

Study ID:




Start Date:

September 2011

Completion Date:

December 2017

Related Keywords:

  • Cervical Cancer
  • Cervical
  • Carcinoma
  • Cisplatin
  • IMRT
  • Radiation
  • International
  • External Beam
  • Brachytherapy
  • LDR
  • HDR
  • IGRT
  • CBCT
  • Uterine Cervical Neoplasms



Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
University Of Miami Miller School Of Medicine Miami, Florida  33010
Moores UC San Diego Cancer Center La Jolla, California  92093
Moffitt Cancer Center and Research Institute, H. Lee Moffitt Cancer Center Tampa, Florida  33612
University of Pittsburgh Cancer Center, UPMC Pittsburgh, Pennsylvania  15243