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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-MC-JHQS |
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The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and 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, intravenous (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 |
|
| 2 | Active Comparator | Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug |
|
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buenos Aires |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21444871 | Derived | Duenas-Gonzalez A, Zarba JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. doi: 10.1200/JCO.2009.25.9663. Epub 2011 Mar 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Drug |
|
| Brachytherapy | Radiation | Brachytherapy, 30-35 Gy over 1 week |
|
| Pelvic radiation | Radiation | Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks |
|
| 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 |
| Local Failure Rate | Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b). | 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 |
| Tumor Response | Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial 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 |
| Number of Participants Who Died From Any Cause at Various Time Points | Original outcome was Overall Survival, which was defined as time from baseline to death from any cause. | baseline to date of death from any cause (includes 60 month follow-up period) |
| Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause. | 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 |
| Argentina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sarajevo | Bosnia and Herzegovina |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mumbai | India |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Karachi | Pakistan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lima | Peru |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bangkok | Thailand |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Grade of Histological Diagnosis | Number | participants |
| ||||||||||||||||
| Karnofsky Performance Status Scale | Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. | Number | participants |
| |||||||||||||||
| Pathological Diagnosis | Number | participants |
| ||||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Stage of Disease | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years | Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented. | Intention-to-treat population includes all randomized participants. Participants were analyzed according to treatment they were randomly assigned. | Posted | Number | participants | 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points | Original outcome was Time to Progressive Disease (TTPD), which is the time from baseline to event (progressive disease or death due to study disease). The median TTPD was not achieved and therefore the cumulative number of participants with event (and those still at risk) at various time points are presented. | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | Posted | Number | participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Local Failure Rate | Local failure rate (LFR) was defined as the the proportion of per-protocol participants who had progressive disease (PD) in the cervix or pelvis. LFR = The number of (a) participants who progressed in the cervix or pelvis divided by (b) the number of participants in each arm. (LFR=a/b). | Per protocol population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment actually received. | Posted | Number | proportion of participants with PD | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Response | Tumor response rate (TRR) defined as number of qualified responder patients with confirmed complete or partial response. | Qualified Responders population included all randomized patients with: Histological diagnosis of cancer of cervix; No previous chemotherapy or radiation therapy; Presence of bidimensionally measurable disease, at least 2 cm in diameter; Treatment with at least one dose of study chemotherapy. Patients were analyzed according to treatment assigned. | Posted | Number | participants | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died From Any Cause at Various Time Points | Original outcome was Overall Survival, which was defined as time from baseline to death from any cause. | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | Posted | Number | participants | baseline to date of death from any cause (includes 60 month follow-up period) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points | Original outome was Progression-Free Survival, which was defined as time from baseline to progressive disease or death due to any cause. | Intent-to-treat population includes all randomized patients. Patients were analyzed according to treatment they were randomly assigned. | Posted | Number | participants | 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 |
|
Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 44 | 259 | ||||
| EG001 | 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 | 17 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Blindness | Eye disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Tongue haemorrhage | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Oedema | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MEDDRA 11.0 | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Blood creatinine | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 11.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vaginal fistula | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MEDDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MEDDRA 11.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MEDDRA 11.0 | Systematic Assessment |
| |
| Alanine aminotransferase | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MEDDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Mexico |
|
| Argentina |
|
| Thailand |
|
| Peru |
|
| India |
|
| Bosnia and Herzegovina |
|
| Panama |
|
| Poorly Differentiated |
|
| Unknown |
|
| Undifferentiated |
|
| Well Differentiated |
|
| 70 - Unable to carry on normal activity |
|
| 80 - Activity with effort; some signs of disease |
|
| 90 - Normal activity; minor signs of disease |
|
| 100 - Normal no complaints; no evidence of disease |
|
| Adeno/Squamous Cell Carcinoma |
|
| Other - Poorly Differentiated Carcinoma |
|
| Other - Squamous |
|
| Caucasian |
|
| East/Southeast Asian |
|
| Hispanic |
|
| Stage IIIB |
|
| Stage IIB |
|
| Stage IVA |
|
|
|
|
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
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|