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Comparative Study of Gemcitabine,Cisplatin and Radiation Versus Cisplatin and Radiation in Cancer of the Cervix
This study has been completed.
Study NCT00191100   Information provided by Eli Lilly and Company
First Received: September 12, 2005   Last Updated: August 8, 2009   History of Changes
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  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

Participant Flow:   Overall Study
  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
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Reporting Groups
  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

Baseline Measures
  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]
 		     
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]
 		     
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
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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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  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

Other Adverse Events
  Gemcitabine/Cisplatin/Radiation Cisplatin/Radiation
Total, other (not including serious) adverse events    
# participants affected 259   251  
Blood and lymphatic system disorders    
Anaemia   † A
      # participants affected / at risk
      # events
175/260 (67.31%)
233  
115/255 (45.10%)
130  
Leukopenia   † A
      # participants affected / at risk
      # events
145/260 (55.77%)
271  
114/255 (44.71%)
124  
Lymphopenia   † A
      # participants affected / at risk
      # events
31/260 (11.92%)
41  
31/255 (12.16%)
32  
Neutropenia   † A
      # participants affected / at risk
      # events
193/260 (74.23%)
378  
74/255 (29.02%)
78  
Thrombocytopenia   † A
      # participants affected / at risk
      # events
66/260 (25.38%)
79  
30/255 (11.76%)
30  
Gastrointestinal disorders    
Abdominal pain   † A
      # participants affected / at risk
      # events
87/260 (33.46%)
115  
57/255 (22.35%)
64  
Constipation   † A
      # participants affected / at risk
      # events
44/260 (16.92%)
47  
34/255 (13.33%)
36  
Diarrhoea   † A
      # participants affected / at risk
      # events
159/260 (61.15%)
207  
131/255 (51.37%)
151  
Dyspepsia   † A
      # participants affected / at risk
      # events
19/260 (7.31%)
19  
14/255 (5.49%)
17  
Nausea   † A
      # participants affected / at risk
      # events
167/260 (64.23%)
280  
155/255 (60.78%)
179  
Proctalgia   † A
      # participants affected / at risk
      # events
20/260 (7.69%)
22  
16/255 (6.27%)
16  
Proctitis   † A
      # participants affected / at risk
      # events
47/260 (18.08%)
52  
25/255 (9.80%)
25  
Vomiting   † A
      # participants affected / at risk
      # events
146/260 (56.15%)
248  
121/255 (47.45%)
138  
General disorders    
Asthenia   † A
      # participants affected / at risk
      # events
28/260 (10.77%)
37  
9/255 (3.53%)
9  
Fatigue   † A
      # participants affected / at risk
      # events
80/260 (30.77%)
126  
57/255 (22.35%)
67  
Pyrexia   † A
      # participants affected / at risk
      # events
31/260 (11.92%)
38  
21/255 (8.24%)
21  
Infections and infestations    
Cystitis   † A
      # participants affected / at risk
      # events
17/260 (6.54%)
19  
10/255 (3.92%)
10  
Vaginal infection   † A
      # participants affected / at risk
      # events
29/260 (11.15%)
33  
22/255 (8.63%)
25  
Injury, poisoning and procedural complications    
Radiation skin injury   † A
      # participants affected / at risk
      # events
72/260 (27.69%)
77  
65/255 (25.49%)
67  
Investigations    
Alanine aminotransferase   † A
      # participants affected / at risk
      # events
19/260 (7.31%)
23  
7/255 (2.75%)
8  
Aspartate aminotransferase   † A
      # participants affected / at risk
      # events
22/260 (8.46%)
26  
4/255 (1.57%)
4  
Creatinine renal clearance decreased   † A
      # participants affected / at risk
      # events
62/260 (23.85%)
81  
51/255 (20.00%)
59  
Metabolism and nutrition disorders    
Anorexia   † A
      # participants affected / at risk
      # events
53/260 (20.38%)
61  
44/255 (17.25%)
46  
Musculoskeletal and connective tissue disorders    
Back pain   † A
      # participants affected / at risk
      # events
29/260 (11.15%)
34  
30/255 (11.76%)
32  
Myalgia   † A
      # participants affected / at risk
      # events
16/260 (6.15%)
18  
8/255 (3.14%)
9  
Nervous system disorders    
Headache   † A
      # participants affected / at risk
      # events
38/260 (14.62%)
47  
23/255 (9.02%)
25  
Renal and urinary disorders    
Dysuria   † A
      # participants affected / at risk
      # events
95/260 (36.54%)
114  
80/255 (31.37%)
85  
Pollakiuria   † A
      # participants affected / at risk
      # events
17/260 (6.54%)
17  
14/255 (5.49%)
15  
Reproductive system and breast disorders    
Genital discharge   † A
      # participants affected / at risk
      # events
20/260 (7.69%)
21  
17/255 (6.67%)
17  
Pelvic pain   † A
      # participants affected / at risk
      # events
71/260 (27.31%)
80  
63/255 (24.71%)
68  
Vaginal discharge   † A
      # participants affected / at risk
      # events
70/260 (26.92%)
84  
62/255 (24.31%)
62  
Vaginal haemorrhage   † A
      # participants affected / at risk
      # events
148/260 (56.92%)
157  
157/255 (61.57%)
162  
Respiratory, thoracic and mediastinal disorders    
Cough   † A
      # participants affected / at risk
      # events
18/260 (6.92%)
18  
15/255 (5.88%)
16  
Skin and subcutaneous tissue disorders    
Pruritus   † A
      # participants affected / at risk
      # events
14/260 (5.38%)
16  
9/255 (3.53%)
9  
Vascular disorders    
Hypertension   † A
      # participants affected / at risk
      # events
19/260 (7.31%)
19  
21/255 (8.24%)
21  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MEDDRA 11.0


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 4015, B9E-MC-JHQS
Study First Received: September 12, 2005
Results First Received: March 30, 2009
Last Updated: August 8, 2009
ClinicalTrials.gov Identifier: NCT00191100     History of Changes
Health Authority: Mexico: National Institute of Public Health, Health Secretariat





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