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

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ClinicalTrials.gov Identifier: NCT01554397
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE October 13, 2011
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
Number of Patients with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 10 weeks while on Treatment ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01554397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
  • Number of Patients with Acute and Late Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 36 months post treatment ]
    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 ]
    To estimate and compare efficacy of cisplatin/IMRT in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2012)
  • IMRT Dose Plan variances across all sites [ Time Frame: 1 week before treatment begins ]
    Determine quality assurance of IMRT for cervical cancer in an international cooperative group setting
  • Number of patients that experience acute and late adverse events as a Measure of Safety and Tolerability [ Time Frame: Up to 36 months post treatment ]
    To estimate and compare the probability of acute and late adverse events
  • Number of patients with locoregional failure [ Time Frame: Up to 36 Months post treatment ]
    To estimate and compare efficacy of cisplatin/IMRT in terms of locoregional failure, disease-specific survival, disease-free survival, and overall survival.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Official Title  ICMJE Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma
Brief 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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Phase II
    All patients receive IMRT with concurrent cisplatin 40 mg/m2
    Interventions:
    • Radiation: Intensity Modulated Radiation Therapy (IMRT)
    • Drug: Cisplatin
  • Active Comparator: Phase III - A
    Patients in Phase III, Arm A receive 4-field box RT with concurrent cisplatin 40 mg/m2
    Intervention: Drug: Cisplatin
  • Experimental: Phase III - B
    Patients in Phase III, Arm B receive IMRT with concurrent cisplatin 40 mg/m2
    Interventions:
    • Radiation: Intensity Modulated Radiation Therapy (IMRT)
    • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 15, 2019)
70
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2012)
425
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Czechia,   India,   Poland,   Thailand,   United States
Removed Location Countries Czech Republic,   Korea, Republic of,   Taiwan,   Turkey,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01554397
Other Study ID Numbers  ICMJE INTERTECC
R21CA162718-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loren Mell, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Loren Mell, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date May 2019

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