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Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical, Carcinoma, Cisplatin, IMRT, Radiation, INTERTECC, International, External Beam, Brachytherapy, LDR, HDR, IGRT, CBCT
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intensity Modulated Radiation Therapy (IMRT)
Type: Radiation
Name: Cisplatin
Type: Drug
Overall Status
Recruiting
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.
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
- 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
Locations
Moores UC San Diego Cancer Center
La Jolla, California, United States
University of Miami Miller School of Medicine
Status: Recruiting
Miami, Florida, United States
University of Pittsburgh Cancer Center, UPMC
Status: Recruiting
Contact: Lorraine Portelance, MD - lportelance@med.miami.edu
Pittsburgh, Pennsylvania, United States
Xijing Hospital
Status: Not yet recruiting
Contact: Hayeon Kim, MS - kimh2@upmc.edu
Xi'an, China
University Hospital Hradec Králové
Status: Recruiting
Contact: Lichun Wei, MD, Ph.D. - 86-29-84775432 - weilichun@fmmu.edu.cn
Hradec Králové, Czech Republic
Tata Memorial Hospital
Status: Recruiting
Contact: Igor Sirák, M.D., Ph.D. - 00420 495 833 373 - pigic@seznam.cz
Parel, Mumbai, India
Asan (Hyundai) Medical Center
Status: Recruiting
Contact: Umesh Mahantshetty, MD - +91-22-2417 7163 - drumeshm@gmail.com
Songpa-Gu, Seoul, Korea, Republic of
Marie Sklodowska Cancer Center
Status: Recruiting
Contact: Sung Ho Park, Ph.D - MICHAEL@AMC.SEOUL.KR
Gliwice, Poland
King Chulalongkorn Hospital
Status: Recruiting
Contact: Rafal Tarnawski, MD, PhD - rafaltarnawski@gmail.com
Bangkok, Thailand
Istanbul Bilim University
Status: Recruiting
Contact: Chonlakiet Khorprasert, MD - chonlakiet@gmail.com
Gayrettepe, Istabul, Turkey
Royal Surrey County Hospital
Status: Not yet recruiting
Contact: Tulay Ercan, PhD - tulaye@doruk.net.tr
Guildford, Surrey, United Kingdom
Status: Recruiting
Contact: Alexandra Stewart - 0148357112 - alexandra.stewart@nhs.net
Start Date
September 2011
Completion Date
December 2017
Sponsors
University of California, San Diego
Source
University of California, San Diego
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page