Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy
| City: |
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Willmar |
| State: |
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Minnesota |
| Zip Code: |
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56201 |
| Conditions: |
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Cervical Cancer |
| Purpose: |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells,
either by killing the cells or by stopping them from dividing. It is not yet known whether
giving radiation therapy together with chemotherapy is more effective than radiation therapy
alone in treating patients with cervical cancer.
PURPOSE: This randomized phase III trial is studying giving radiation therapy together with
chemotherapy to see how well it works compared to radiation therapy alone in treating
patients with stage I or stage II cervical cancer who previously underwent surgery.
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| Study Summary: |
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OBJECTIVES:
Primary
- To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in
patients with intermediate-risk factors stage I-IIA cervical cancer after treatment
with radical hysterectomy.
Secondary
- To compare the overall survival (OS) of patients treated with these regimens.
- To assess differences in incidence and severity of regimen-attributed adverse events in
these patients.
- To provide assessment of patient risk vs benefit (positive study only).
- To determine whether post-operative adjuvant CRT improves the health-related
quality-of-life compared to RT alone.
- To compare toxicity profiles with particular focus on treatment-related genitourinary,
gastrointestinal, neurological, pain, and sexual adverse events in these patients.
Tertiary
- To bank archival tumor tissue for research studies, including studies that evaluate the
association between biomarkers, RFS, OS, and clinical-surgical-pathologic
characteristics in patients treated with these regimens.
- To bank DNA from whole blood for research studies, including studies that evaluate
associations between single nucleotide polymorphisms (SNPs), and measures of clinical
outcome, including RFS, OS, and adverse events in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to
capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs
middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs
intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo pelvic EBRT or IMRT 5 days a week for 5.5 weeks.
- Arm II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy
as in arm I. Treatment with cisplatin repeats every 7 days for up to 6 weeks in the
absence of disease progression or unacceptable toxicity.
Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy
(FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at
baseline and periodically during study.
Tumor tissue and blood samples may be collected and banked for future biomarker and other
analysis.
After completion of study therapy, patients are followed up every 3 months for 2 years, and
then every 6 months for 3 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Pathologically confirmed primary cervical cancer comprising one of the following cell
types:
- Squamous cell carcinoma
- Adenosquamous carcinoma
- Adenocarcinoma
- Stage I-IIA disease
- Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
- Patients with depth of stromal invasion and lymphovascular space involvement to be
pathologically confirmed must meet the following criteria:
- Positive capillary-lymphovascular space involvement and one of the following:
- Deep third penetration
- Middle third penetration, clinical tumor ≥ 2 cm
- Superficial third penetration, clinical tumor ≥ 5 cm
- Negative capillary-lymphatic space involvement
- Middle or deep third penetration, clinical tumor ≥ 4 cm
- No patients with tumor in the parametria, pelvic lymph nodes, or any other
extra-uterine site or with positive surgical margins
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphate ≤ 3 times ULN
- SGOT ≤ 3 times ULN
- No septicemia or severe infection
- No intestinal obstruction or gastrointestinal bleeding
- No post-operative fistula
- No circumstances that do not permit completion of the study or the required study
follow-up
- No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney
or renal transplant)
- No prior malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks but ≤ 8 weeks since surgery
- No prior radiotherapy or chemotherapy for cancer of the cervix
- No prior cancer treatment that contraindicates this protocol therapy
- No concurrent brachytherapy boost
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| NCT ID: |
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NCT01101451 |
| Primary Contact: |
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Principal Investigator
Sang Y. Ryu, MD
Korea Cancer Center Hospital
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| Backup Contact: |
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N/A |
| Location Contact: |
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Willmar, Minnesota 56201
United States
Patrick J. Flynn, MD
Phone: 612-863-8585
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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