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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University of California, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01554397
First received: March 8, 2012
Last updated: July 20, 2013
Last verified: March 2012

March 8, 2012
July 20, 2013
September 2011
December 2016   (final data collection date for primary outcome measure)
Number of Patients with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 10 weeks while on Treatment ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01554397 on ClinicalTrials.gov Archive Site
  • Number of Patients with Acute and Late Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 36 months post treatment ] [ Designated as safety issue: Yes ]
    To estimate and compare the probability of acute and late adverse events
  • Number of Patients with Locoregional Failure as a Measure of Recurrence [ Time Frame: Up to 36 Months post treatment ] [ Designated as safety issue: No ]
    To estimate and compare efficacy of cisplatin/IMRT in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.
Same as current
Not Provided
Not Provided
 
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Cancer
  • Radiation: Intensity Modulated Radiation Therapy (IMRT)
    45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks
  • Drug: Cisplatin
    Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
425
December 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Mary Wright 858-822-5367 mewright@ucsd.edu
Contact: Meaghan Stirn 858-822-5354 mstirn@ucsd.edu
United States,   China,   Czech Republic,   India,   Korea, Republic of,   Turkey,   United Kingdom
 
NCT01554397
INTERTECC, R21CA162718-01
Yes
Loren Mell, MD, University of California, San Diego
University of California, San Diego
National Cancer Institute (NCI)
Study Director: Loren Mell, MD University of California, San Diego
Study Chair: Mary Ann Rose, MD University of California, San Diego
University of California, San Diego
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP