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Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer Clinical research trials and Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer  Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
For Condition: cervical adenosquamous cell carcinoma,stage 2A cervical cancer,stage 1B cervical cancer,stage 2B cervical cancer,cervical squamous cell carcinoma,cervical adenocarcinoma
Status: Recruiting
Sponsor(s): EORTC Gynecological Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.
Details: OBJECTIVES: - Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days. - Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given. Quality of life is assessed at baseline, after completion of the last chemotherapy course (arm I) or 4-8 weeks after completion of chemoradiotherapy (arm II), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cervical cancer, including the following subtypes: - Squamous cell carcinoma - Adenosquamous cell carcinoma - Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma) - FIGO stage IB2, IIA (greater than 4 cm), or IIB PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.46 mg/dL Renal: - Creatinine clearance greater than 60 mL/min Other: - No other prior or concurrent malignancy except adequately treated basal cell skin cancer - No psychological, familial, sociological, or geographical condition that would preclude study - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - Not specified Other: - No other concurrent anticancer agent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NicolettaColombo, , European Institute of Oncology
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-80-361-1111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Ospedale Mauriziano Umberto I *Recruiting*
Torino, , 10128
Italy
Recruiting Contact Person 39-11-508-1111
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Contact Person 34-330-3000
European Institute of Oncology *Recruiting*
Milano, , 20141
Italy
Recruiting Contact Person 39-2-574-891
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3001-301
Portugal
Recruiting Contact Person 351-39-403-939
Hospital de Clinicas "Jose De San Martin" *Recruiting*
Buenos Aires, , 1120
Argentina
Recruiting Contact Person 54-1-5950-8000
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Leiden University Medical Center *Recruiting*
Leiden, , 2300 RC
Netherlands
Recruiting Contact Person 31-71-526-911
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-934-000
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Naples, , 80131
Italy
Recruiting Contact Person 39-81-590-3269
Medical University of Gdansk *Recruiting*
Gdansk, , 80-211
Poland
Recruiting Contact Person 48-58-349-2222
Clinica Universita *Recruiting*
Turin, , 10126
Italy
Recruiting Contact Person 39-11-434-5345
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Contact Person 44-1923-826-111
Western Infirmary *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting Contact Person 44-141-330-4006
Additional Information:
Study ID Numbers: CDR0000069375; EORTC-55994
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039338
Other Stage 1b Cervical Cancer Studies:
1. Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
2. Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
3. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
4. Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
5. Cisplatin Combined with Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer
Related Studies:
Other stage 1B cervical cancer Clinical Trials
Other Clinical Trials
Other Amsterdam Clinical Trials
Chemotherapy Followed By Surgery Compared With Radiation Therapy Plus Chemotherapy in Treating Patients With Stage IB or Stage II Cervical Cancer
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