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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Condition: |
Cancer of Cervix |
| Interventions: |
Drug: Gemcitabine Drug: Cisplatin Radiation: Brachytherapy Radiation: Pelvic radiation |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Gemcitabine/Cisplatin/Radiation |
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week Two week rest period with no chemotherapy or radiation Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles |
| Cisplatin/Radiation |
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week |
| Gemcitabine/Cisplatin/Radiation | Cisplatin/Radiation | |
|---|---|---|
| STARTED | 259 | 256 |
| COMPLETED | 217 | 244 |
| NOT COMPLETED | 42 | 12 |
| Adverse Event | 18 | 1 |
| Lost to Follow-up | 2 | 0 |
| Patient Moved | 0 | 1 |
| Withdrawal by Subject | 9 | 3 |
| Protocol Entry Criteria Not Met | 2 | 1 |
| Clinical Relapse | 2 | 1 |
| Lack of Efficacy, Progressive Disease | 1 | 2 |
| Lack of Efficacy, Stable Disease | 1 | 0 |
| Physician Decision | 3 | 1 |
| Death from Study Drug Toxicity | 2 | 0 |
| Protocol Violation | 1 | 1 |
| Death from Other Cause | 1 | 0 |
| Reason Not Specified | 0 | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Gemcitabine/Cisplatin/Radiation |
Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week Two week rest period with no chemotherapy or radiation Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles |
| Cisplatin/Radiation |
Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week |
| Gemcitabine/Cisplatin/Radiation | Cisplatin/Radiation | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
259 | 256 | 515 |
|
Age [units: years] Mean ± Standard Deviation |
45.8 ± 9.8 | 46.5 ± 9.2 | 46.1 ± 9.5 |
|
Gender [units: participants] |
|||
| Female | 259 | 256 | 515 |
| Male | 0 | 0 | 0 |
|
Region of Enrollment [units: participants] |
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| Pakistan | 27 | 29 | 56 |
| Mexico | 28 | 31 | 59 |
| Argentina | 17 | 18 | 35 |
| Thailand | 34 | 33 | 67 |
| Peru | 29 | 31 | 60 |
| India | 60 | 56 | 116 |
| Bosnia and Herzegovina | 33 | 28 | 61 |
| Panama | 31 | 30 | 61 |
|
Grade of Histological Diagnosis [units: participants] |
|||
| Moderately Differentiated | 114 | 119 | 233 |
| Poorly Differentiated | 48 | 44 | 92 |
| Unknown | 69 | 69 | 138 |
| Undifferentiated | 2 | 0 | 2 |
| Well Differentiated | 26 | 24 | 50 |
|
Karnofsky Performance Status Scale[1] [units: participants] |
|||
| Unknown (Missing) | 1 | 0 | 1 |
| 70 - Unable to carry on normal activity | 0 | 1 | 1 |
| 80 - Activity with effort; some signs of disease | 8 | 9 | 17 |
| 90 - Normal activity; minor signs of disease | 147 | 145 | 292 |
| 100 - Normal no complaints; no evidence of disease | 103 | 101 | 204 |
|
Pathological Diagnosis [units: participants] |
|||
| Adenocarcinoma of Cervix | 17 | 15 | 32 |
| Adeno/Squamous Cell Carcinoma | 198 | 199 | 397 |
| Other - Poorly Differentiated Carcinoma | 1 | 0 | 1 |
| Other - Squamous | 43 | 42 | 85 |
|
Race/Ethnicity [units: participants] |
|||
| Western Asian | 87 | 85 | 172 |
| Caucasian | 33 | 29 | 62 |
| East/Southeast Asian | 34 | 33 | 67 |
| Hispanic | 105 | 109 | 214 |
|
Stage of Disease [units: participants] |
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| Stage IIIA | 1 | 1 | 2 |
| Stage IIIB | 94 | 94 | 188 |
| Stage IIB | 160 | 156 | 316 |
| Stage IVA | 4 | 5 | 9 |
|
Height [units: centimeters] Mean ± Standard Deviation |
155.2 ± 6.6 | 154.6 ± 6.7 | 154.9 ± 6.6 |
|
Weight [units: kilograms] Mean ± Standard Deviation |
61.2 ± 11.3 | 62.4 ± 13.0 | 61.8 ± 12.2 |
| [1] | Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. |
|---|
Outcome Measures
| 1. Primary: | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years [ Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively ] |
| 2. Secondary: | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points [ Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively ] |
| 3. Secondary: | Local Failure Rate [ Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively ] |
| 4. Secondary: | Tumor Response [ Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively ] |
| 5. Secondary: | Number of Participants Who Died From Any Cause at Various Time Points [ baseline to date of death from any cause (includes 60 month follow-up period) ] |
| 6. Secondary: | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points [ Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively ] |
