Clinical trial · Interventional
Comparison of Three Chemotherapy Regimens in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for cervical cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different chemotherapy regimens in treating patients with stage IVB, recurrent, or persistent cervical cancer.
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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy
* Eligible subtypes:
* Squamous cell carcinoma
* Adenosquamous carcinoma
* Adenocarcinoma
* Measurable disease by physical examination, radiography, CT scan, or MRI
* Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined
* No craniospinal metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT no greater than 3 times normal
* Alkaline phosphatase no greater than 3 times normal
Renal:
* Creatinine no greater than 1.5 mg/dL
* No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No clinically significant infection
* No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Body surface area no greater than 2.0 m\^2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 6 weeks since prior chemoradiotherapy and recovered
* No prior chemotherapy except when used concurrently with radiotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* See Chemotherapy
* At least 3 weeks since prior radiotherapy only and recovered
Surgery:
* Recovered from prior surgery
Other:
* No prior anticancer treatment that would preclude study therapyReferences
Publications (11)
- BACKGROUNDChase DM, Huang HQ, Wenzel L, Cella D, McQuellon R, Long HJ, Moore DH, Monk BJ. Quality of life and survival in advanced cervical cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):315-9. doi: 10.1016/j.ygyno.2012.01.047. Epub 2012 Feb 1. PMID 22307062
- BACKGROUNDMoore DH, Tian C, Monk BJ, Long HJ, Omura GA, Bloss JD. Prognostic factors for response to cisplatin-based chemotherapy in advanced cervical carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2010 Jan;116(1):44-9. doi: 10.1016/j.ygyno.2009.09.006. Epub 2009 Oct 22. PMID 19853287
- BACKGROUNDPaton F, Paulden M, Saramago P, Manca A, Misso K, Palmer S, Eastwood A. Topotecan for the treatment of recurrent and stage IVB carcinoma of the cervix. Health Technol Assess. 2010 May;14 Suppl 1:55-62. doi: 10.3310/hta14Suppl1/08. PMID 20507804
- BACKGROUNDPlaxe SC, Brooks SE, Tian C, Bloss JD, Moore DH, Long HJ. Influence of race on tolerance of platinum-based chemotherapy and clinical outcomes in women with advanced and recurrent cervical cancer: a pooled analysis of 3 Gynecologic Oncology Group studies. Am J Obstet Gynecol. 2008 Nov;199(5):539.e1-6. doi: 10.1016/j.ajog.2008.04.038. Epub 2008 Jun 20. PMID 18565487
- BACKGROUNDMoore DH, Tian C, Monk BJ, et al.: Factors predictive of response to cisplatin-based chemotherapy in stage IVB persistent or recurrent cervical carcinoma: a multivariate analysis of three Gynecologic Oncology Group trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-5534, 282s, 2007.
- BACKGROUNDTewari KS, Monk BJ. Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer. Curr Oncol Rep. 2005 Nov;7(6):419-34. doi: 10.1007/s11912-005-0007-z. PMID 16221379
- RESULTLong HJ 3rd, Monk BJ, Huang HQ, Grendys EC Jr, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group. Clinical results and quality of life analysis for the MVAC combination (methotrexate, vinblastine, doxorubicin, and cisplatin) in carcinoma of the uterine cervix: A Gynecologic Oncology Group study. Gynecol Oncol. 2006 Mar;100(3):537-43. doi: 10.1016/j.ygyno.2005.09.023. Epub 2005 Oct 10.