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
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Radiation: Intensity Modulated Radiation Therapy (IMRT)
Drug: Cisplatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II/III Clinical Trial of Intensity Modulated Radiation Therapy With Concurrent Cisplatin for Stage I-IVA Cervical Carcinoma

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 425
Study Start Date: September 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554397

Contacts
Contact: Mary Wright 858-822-5367 mewright@ucsd.edu
Contact: Meaghan Stirn 858-822-5354 mstirn@ucsd.edu

Locations
United States, California
Moores UC San Diego Cancer Center Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Loren Mell, MD         
Sub-Investigator: Catheryn Yashar, MD         
Sub-Investigator: Arno Mundt, MD         
United States, Florida
University of Miami Miller School of Medicine Not yet recruiting
Miami, Florida, United States, 33136
Contact: Lorraine Portelance, MD       lportelance@med.miami.edu   
Principal Investigator: Aaron Wolfson, MD         
Moffitt Cancer Center and Research Institute, H. Lee Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Daniel Opp, PhD    813-340-1515    daniel.opp@moffitt.org   
Principal Investigator: Eleanor Harris, MD         
United States, Iowa
Holden Comprehensive Cancer Center Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Sarah McGuire, PhD       sarah-mcguire@uiowa.edu   
Principal Investigator: Geraldine Jacobson, MD         
United States, Pennsylvania
University of Pittsburgh Cancer Center, UPMC Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15243
Contact: Hayeon Kim, MS       kimh2@upmc.edu   
Principal Investigator: Sushil Beriwal, MD         
China, Shaanxi
Medical College of Xi'an Jiatong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Liu Zi, MD       liuzmail@163.com   
China
Xijing Hospital Recruiting
Xi'an, China, 710032
Contact: Lichun Wei, MD, Ph.D.    86-29-84775432    weilichun@fmmu.edu.cn   
Principal Investigator: Mei Shi, MD         
Czech Republic
University Hospital Hradec Králové Recruiting
Hradec Králové, Czech Republic
Contact: Igor Sirák, M.D., Ph.D.    00420 495 833 373    pigic@seznam.cz   
Contact: Linda Kasaova, M.Sc.         
Principal Investigator: Igor Sirák, MD, Ph.D         
India
Tata Memorial Hospital Not yet recruiting
Parel, Mumbai, India, 400 012
Contact: Umesh Mahantshetty, MD    +91-22-2417 7163    drumeshm@gmail.com   
Principal Investigator: Shyam Kishore Shrivastava, MD         
Korea, Republic of
Asan (Hyundai) Medical Center Recruiting
Songpa-Gu, Seoul, Korea, Republic of
Contact: Sung Ho Park, Ph.D       MICHAEL@AMC.SEOUL.KR   
Principal Investigator: Sung Ho Park, Ph.D.         
Turkey
Istanbul Bilim University Not yet recruiting
Gayrettepe, Istabul, Turkey, 34340
Contact: Tulay Ercan, PhD       tulaye@doruk.net.tr   
Principal Investigator: lokesh Viswanath, MD         
United Kingdom
Royal Surrey County Hospital Not yet recruiting
Guildford, Surrey, United Kingdom, 7XX
Contact: Alexandra Stewart    0148357112    alexandra.stewart@nhs.net   
Principal Investigator: Alexandra Stewart, DM, MRCP, FRCR         
Sponsors and Collaborators
University of California, San Diego
Investigators
Study Director: Loren Mell, MD University of California, San Diego
Study Chair: Mary Ann Rose, MD University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Loren Mell, MD, Assistant Professor, Director Division of Clinical and Translational Research, Department of Radiation Medicine and Applied Sciences., University of California, San Diego
ClinicalTrials.gov Identifier: NCT01554397     History of Changes
Other Study ID Numbers: INTERTECC, R21CA162718-01
Study First Received: March 8, 2012
Last Updated: July 20, 2013
Health Authority: United States: Institutional Review Board
Czech Republic: Ethics Committee
Korea: Institutional Review Board

Keywords provided by University of California, San Diego:
Cervical
Carcinoma
Cisplatin
IMRT
Radiation
INTERTECC
International
External Beam
Brachytherapy
LDR
HDR
IGRT
CBCT

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Neoplasms
Genital Diseases, Female
Uterine Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014