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A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer . PURPOSE/OBJECTIVE This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma . MATERIALS/METHODS Between May 2000 and May 2004 , 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m² Cisplatin ( group I ; 16 patients ) or 50 mg/m² paclitaxel ( group II ; 15 patients ) concurrently with radiotherapy . Median total dose to point A was 74 Gy ( range : 66-92 Gy ) for group I and 66 Gy ( range : 40-98 Gy ) for group II . Median follow-up time was 46 months . RESULTS Patient and tumor characteristics were similar in both groups . The mean number of chemotherapy cycles was also comparable with 87 % and 80 % of patients receiving at least 4 doses in groups I and II , respectively . Seven patients ( 44 % ) of group I and 8 patients ( 53 % ) of group II developed tumor recurrence . The Median Survival time was not reached for Group I and 53 months for group II . The proportion of patients surviving at 2 and 5 years was 78 % and 54 % for group I and 73 % and 43 % for group II respectively . CONCLUSIONS This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix .
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Intervention_Physical
radiotherapy
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
paclitaxel
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Intervention_Physical
standard radiotherapy
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Participant_Condition
advanced cervical cancer
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Participant_Condition
advanced cervical carcinoma
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Participant_Sample-size
31
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Participant_Condition
FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence