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Fairbanks, Alaska 99701

  • Stage IIA

Purpose:

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.


Study summary:

PRIMARY OBJECTIVE: 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). QUALITY OF LIFE OBJECTIVE: I. 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). TRANSLATIONAL RESEARCH 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.


Criteria:

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


Study is Available At:


Original ID:

GOG-0263


NCT ID:

NCT01101451


Secondary ID:

NCI-2011-02037


Study Acronym:


Brief Title:

Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery


Official Title:

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)


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GOG Foundation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

341


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sang Y Ryu
Principal Investigator
NRG Oncology

Study Dates

Start Date:April 12, 2010
Primary Completion Date:April 11, 2024
Primary Completion Type:Anticipated
Verification Date:May 2022
Last Changed Date:May 17, 2022
First Received Date:April 9, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Recurrence-free survival (RFS)
Time Frame:From protocol registration to date of first documented recurrence, death or date of last contact, as
Safety Issues:False
Description:Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha=0.05) will be used to compare RFS between treatment arms.
Outcome Type:Secondary Outcome
Measure:Overall survival (OS)
Time Frame:From entry into the study to death; or for living patients, the date of last contact regardless of w
Safety Issues:False
Description:Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test (alpha=0.05) will be used to compare OS between treatment arms.
Outcome Type:Secondary Outcome
Measure:Local control
Time Frame:Up to 11 years
Safety Issues:False
Description:Assessed with Exact Logistic Regression adjusted known prognostic factors.
Outcome Type:Secondary Outcome
Measure:Site(s) of recurrence
Time Frame:Up to 11 years
Safety Issues:False
Description:The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatm
Outcome Type:Secondary Outcome
Measure:Incidence of adverse events
Time Frame:Up to 5 years
Safety Issues:False
Description:Graded according to the active version of Common Terminology Criteria for Adverse Events (CTCAE). In addition to displaying frequency of adverse events for each grade category, significance of observed differences between treatment arms within each catego
Outcome Type:Secondary Outcome
Measure:Patient risk-benefit
Time Frame:Up to 11 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Treatment compliance
Time Frame:Up to 11 years
Safety Issues:False
Description:Assessed by the number of cycles and amount of chemoradiotherapy administered, treatment span, incidence and duration of treatment delays, reason for delays, and reason why off study therapy.
Outcome Type:Secondary Outcome
Measure:Quality of life
Time Frame:Up to 9 months following the first day of treatment
Safety Issues:False
Description:Assessed using the Functional Assessment of Cancer Therapy (FACT)-Cervix, FACT-Gynecologic Oncology Group (GOG)/neurotoxicity 4 subscale, and the Brief Pain Inventory (BPI).

Study Interventions

Intervention Type:Other
Name:Questionnaire Administration
Description:Ancillary studies
Arm Name:Arm I (EBRT, IMRT)
Intervention Type:Other
Name:Quality-of-Life Assessment
Description:Ancillary studies
Arm Name:Arm I (EBRT, IMRT)
Other Name:Quality of Life Assessment
Intervention Type:Other
Name:Laboratory Biomarker Analysis
Description:Correlative studies
Arm Name:Arm I (EBRT, IMRT)
Intervention Type:Radiation
Name:Intensity-Modulated Radiation Therapy
Description:Undergo radiotherapy
Arm Name:Arm I (EBRT, IMRT)
Other Name:IMRT
Intervention Type:Radiation
Name:External Beam Radiation Therapy
Description:Undergo radiotherapy
Arm Name:Arm I (EBRT, IMRT)
Other Name:Definitive Radiation Therapy
Intervention Type:Drug
Name:Cisplatin
Description:Given IV
Arm Name:Arm II (cisplatin, EBRT, IMRT)
Other Name:Abiplatin

Study Arms

Study Arm Type:Experimental
Arm Name:Arm II (cisplatin, EBRT, IMRT)
Description: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.
Study Arm Type:Active Comparator
Arm Name:Arm I (EBRT, IMRT)
Description:Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:GOG Foundation
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: February 08, 2023

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