Clinical trial · Interventional
Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma
A Pilot Study of Weekly IV Topotecan and Cisplatin With Concurrent Pelvic Radiation in the Treatment of Stages IB2 - IVA Cervical Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There will be approximately 14,000 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4,000 deaths from this disease. This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates (RR) with improvements in durable remissions and overall survival. Though the incidence and mortality in the U.S. dropped steadily from years 1940 to 2000, there has recently been a plateau, arresting the decline. With the routine addition of systemic Cisplatin (CDDP) chemotherapy to local regional radiation, mortality from advanced cervical cancer in the United States is expected to further decrease. However, further advances in this disease are needed.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topotecan
- description
- Adding weekly topotecan to cisplatin in patients with primary, locally advanced carcinoma of the cervix receiving pelvic irradiation.
- interventionNames
- Drug: Topotecan
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Number of Participants in which topotecan improves response rate (RR) when added to cisplatin in treating metastatic and recurrent cervical cancer
- timeFrame
- 5 years
- description
- Topotecan improves response rate (RR), progression-free survival (PFS) and overall survival (OS) when added to cisplatin in treating metastatic and recurrent cervical cancer. The objective of this study was to assess the feasibility of adding weekly topotecan to cisplatin in patients with primary, locally advanced carcinoma of the cervix receiving pelvic irradiation.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage I-2, II-B, III-B, IV-A. 2. Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, MRI or lymphadenectomy. 3. Patients with adequate bone marrow function: ANC greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl, and Hemoglobin \> 10 mg/dl. 4. Patients with adequate renal function: Creatinine equal to or less than 1.5 mg%. 5. Patients with adequate hepatic function: Bilirubin less than or equal to 1.5 x normal and SGOT and Alkaline phosphatase less than or equal to 3 x normal. 6. Patients who have signed an approved informed consent. 7. Patients with GOG Performance Status of 0, 1, 2, or 3. 8. Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception. 9. Patients who are suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation. Exclusion Criteria: 1. Patients who cannot be or have not been adequately clinically staged. 2. Patients with lower one-third vaginal involvement. 3. Patients with septicemia or severe infection. 4. Patients with circumstances that will not permit completion of the study or required follow-up. 5. Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy. 6. Patients with carcinoma of the cervical stump. 7. Patients who are lactating or pregnant.
References
Publications (1)
- RESULTGatcliffe TA, Tewari KS, Shah A, Brewster WR, Burger RA, Kuo JV, Monk BJ. A feasibility study of topotecan with standard-dose cisplatin and concurrent primary radiation therapy in locally advanced cervical cancer. Gynecol Oncol. 2009 Jan;112(1):85-9. doi: 10.1016/j.ygyno.2008.09.029. Epub 2008 Nov 1. PMID 18977518