Trial Title:
Study With Intensity Modulated Radiation Therapy With Cisplatin to Treat Stage I-IVA Cervical Cancer
NCT ID:
NCT01554397
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Cisplatin
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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity Modulated Radiation Therapy (IMRT)
Description:
45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over
5-5.5 weeks
Arm group label:
Phase II
Arm group label:
Phase III - B
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
Arm group label:
Phase II
Arm group label:
Phase III - A
Arm group label:
Phase III - B
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moores UC San Diego Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Facility:
Name:
University of Miami Miller School of Medicine
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Xijing Hospital
Address:
City:
Xi'an
Zip:
710032
Country:
China
Facility:
Name:
University Hospital Hradec Králové
Address:
City:
Hradec Králové
Country:
Czechia
Facility:
Name:
Tata Memorial Hospital
Address:
City:
Parel
Zip:
400 012
Country:
India
Facility:
Name:
Marie Sklodowska Cancer Center
Address:
City:
Gliwice
Country:
Poland
Facility:
Name:
King Chulalongkorn Hospital
Address:
City:
Bangkok
Country:
Thailand
Start date:
October 13, 2011
Completion date:
June 2020
Lead sponsor:
Agency:
University of California, San Diego
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, San Diego
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01554397
http://radonc.ucsd.edu/Pages/default.aspx
