Status:
TERMINATED
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
NCIC Clinical Trials Group
Gynecologic Oncology Group
Conditions:
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical canc...
Detailed Description
PRIMARY OBJECTIVE: I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazam...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
- Stage IB2, IIA, IIB, IIIB, or IVA disease
- Stage IIA tumors must be \> 4 cm
- Primary, untreated disease
- Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy
- Must have been adequately clinically staged
- Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy
- No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)
- No carcinoma of the cervical stump
- Performance status - GOG 0-3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min
- No New York Heart Association class III-IV heart failure
- No history of myocardial infarction
- No unstable angina
- No uncontrolled hypertension
- No pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No septicemia or severe infection
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
- No prior coronary artery bypass surgery
- No prior cancer therapy that would preclude study treatment
- No concurrent angina medication
- No concurrent intensity-modulated radiotherapy
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00262821
Start Date
February 1 2006
End Date
August 1 2010
Last Update
July 23 2019
Active Locations (282)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006