Clinical trial · Interventional
Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study drug no longer available resulting in lack of study drug for participants.
Summary
Brief summary (as posted)
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 cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Cell Carcinoma | Cervical Adenosquamous Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| tirapazamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (cisplatin)
- description
- Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
- interventionNames
- Drug: cisplatin
- type
- EXPERIMENTAL
- label
- Arm II (cisplatin, tirapazamine)
- description
- Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
- interventionNames
- Drug: cisplatin
- Drug: tirapazamine
Primary outcomes (1)
- measure
- Progression-free Survival - Percentage of Patients Alive and Progression Free
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 radiotherapyReferences
Publications (1)
- DERIVEDDiSilvestro PA, Ali S, Craighead PS, Lucci JA, Lee YC, Cohn DE, Spirtos NM, Tewari KS, Muller C, Gajewski WH, Steinhoff MM, Monk BJ. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study. J Clin Oncol. 2014 Feb 10;32(5):458-64. doi: 10.1200/JCO.2013.51.4265. Epub 2014 Jan 6. PMID 24395863