Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Status: | Recruiting |
---|---|
Conditions: | Cervical Cancer, Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/14/2019 |
Start Date: | April 12, 2010 |
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 (NCT #01101451)
This randomized phase III trial studies radiation therapy with chemotherapy to see how well
they work compared to radiation therapy alone in treating patients with stage I-IIA cervical
cancer who previously underwent surgery. 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, by stopping them from dividing, or by
stopping them from spreading. 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.
they work compared to radiation therapy alone in treating patients with stage I-IIA cervical
cancer who previously underwent surgery. 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, by stopping them from dividing, or by
stopping them from spreading. 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.
PRIMARY OBJECTIVES:
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage
I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical
hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when
compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors
after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of
therapy-attributed adverse events utilizing the active version of Common Terminology Criteria
for Adverse Events (CTCAE).
III. To provide assessment of patient risk version (vs) benefit (positive study only).
IV. To determine whether post-operative adjuvant CRT improves the health-related
quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer
Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles
(with particular focus on treatment related genitourinary, gastrointestinal, neurological,
pain and sexual adverse events).
TERTIARY OBJECTIVES:
I. 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 randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (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 randomized to
post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated
radiation therapy (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 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage
I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical
hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when
compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors
after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of
therapy-attributed adverse events utilizing the active version of Common Terminology Criteria
for Adverse Events (CTCAE).
III. To provide assessment of patient risk version (vs) benefit (positive study only).
IV. To determine whether post-operative adjuvant CRT improves the health-related
quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer
Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles
(with particular focus on treatment related genitourinary, gastrointestinal, neurological,
pain and sexual adverse events).
TERTIARY OBJECTIVES:
I. 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 randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (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 randomized to
post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated
radiation therapy (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 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.
Inclusion Criteria:
- Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma,
adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical
hysterectomy with pelvic lymphadenectomy
- Patients with the following characteristics (depth of stromal invasion and
lymphovascular space involvement to be pathologically confirmed):
- 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
- Absolute neutrophil count (ANC) >= 1,500/mcl
- Platelets >= 100,000/mcl
- Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60
mL/min
- Bilirubin =< 1.5 x normal
- Alkaline phosphate =< 3 x normal
- Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
- Gynecologic Oncology Group (GOG) performance status 0, 1, 2
- Patients should not be randomized less than 3 weeks post-surgery but will not be
acceptable for randomization more than 8 weeks post-surgery
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
- Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine
site or with positive surgical margins
- Patients with septicemia or severe infection
- Patients with intestinal obstruction or gastrointestinal bleeding
- Patients with postoperative fistula
- Patients with cervix cancer who have received any previous radiation or chemotherapy
- Patients whose circumstances do not permit completion of the study or the required
follow-up
- Patients with renal abnormalities requiring modification of radiation field (pelvic
kidney, renal transplant, etc.)
- Patients with GOG performance status of 3 or 4
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
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808 North 39th Avenue
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1200 Old York Road
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Phone: 330-375-6101
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Phone: 215-728-2983
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1500 Red River Street
Austin, Texas 78701
Austin, Texas 78701
Principal Investigator: James S. Ferriss
Phone: 512-324-7991
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 907-458-5380
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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6701 N Charles St
Baltimore, Maryland 21204
Baltimore, Maryland 21204
(443) 849-2000
![Greater Baltimore Medical Center](/wp-content/uploads/logos/greater-baltimore-medical-center.png)
Principal Investigator: Geoffrey A. Neuner
Phone: 443-849-3706
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Basking Ridge, New Jersey 07920
Principal Investigator: Mario M. Leitao
Phone: 212-639-5007
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Baton Rouge, Louisiana 70815
Principal Investigator: Milton G. Fort
Phone: 412-339-5294
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Baton Rouge, Louisiana 70809
Principal Investigator: Milton G. Fort
Phone: 225-215-1353
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 907-458-5380
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Bellevue, Washington 98005
Principal Investigator: Keith S. Lanier
Phone: 503-215-6412
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Bellingham, Washington 98225
Principal Investigator: Dan S. Zuckerman
Phone: 360-715-4133
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
![Strecker Cancer Center-Belpre](/wp-content/uploads/logos/strecker-cancer-center-belpre.jpg)
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Bend, Oregon 97701
Principal Investigator: Dan S. Zuckerman
Phone: 541-706-2909
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Berkeley, California 94704
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
![Walter Reed National Military Medical Center](/wp-content/uploads/logos/walter-reed-national-military-medical-center.jpg)
Principal Investigator: Yovanni Casablanca
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethlehem, Pennsylvania 18015
Principal Investigator: Nicholas P. Taylor
Phone: 610-954-3582
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
Billings, Montana 59101
406-237-7000
![Saint Vincent Healthcare](/wp-content/uploads/logos/saint-vincent-healthcare.png)
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
Bloomington, Illinois 61701
309-662-2102
![Illinois CancerCare-Bloomington](/wp-content/uploads/logos/illinois-cancercare-bloomington.gif)
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
Phone: 217-876-4740
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100 E Idaho St
Boise, Idaho 83712
Boise, Idaho 83712
(208) 381-2711
![Saint Luke's Mountain States Tumor Institute](/wp-content/uploads/logos/saint-luke-s-mountain-states-tumor-institute.gif)
Principal Investigator: Dan S. Zuckerman
Phone: 412-339-5294
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
Phone: 309-243-3605
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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1100 Balsam Ave
Boulder, Colorado 80304
Boulder, Colorado 80304
(303) 440-2273
![Boulder Community Hospital](/wp-content/uploads/logos/boulder-community-hospital.jpg)
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 888-785-6789
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915 Highland Blvd
Bozeman, Montana 59715
Bozeman, Montana 59715
(406) 414-5000
![Bozeman Deaconess Hospital](/wp-content/uploads/logos/bozeman-deaconess-hospital.jpg)
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 417-269-4520
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 734-712-3671
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7575 Grand River Avenue
Brighton, Michigan 48114
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 734-712-3671
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Brooklyn, New York 11203
Principal Investigator: Ovadia Abulafia
Phone: 718-613-8324
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263 7th Avenue
Brooklyn, New York 11215
Brooklyn, New York 11215
Principal Investigator: Katherine Economos
Phone: 718-780-3677
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Burbank, California
Principal Investigator: Dan S. Zuckerman
Phone: 818-847-4793
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1501 Trousdale Drive
Burlingame, California 94010
Burlingame, California 94010
Principal Investigator: Stacy D. D'Andre
Phone: 415-209-2686
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