Trial Outcomes & Findings for Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer (NCT NCT00085631)

Last Updated: 2013-09-17

Results Overview

Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

101 participants

Primary outcome timeframe

3 months from start of therapy

Results posted on

2013-09-17

Participant Flow

Patients were recruited between 2003 and 2008 from seven different university hospitals and medical centers internationally. A total of 101 patients were enrolled from these institutions and randomized by institution, disease stage and age.

Participant flow includes patients who were enrolled and randomized into the study. A third group of patients (Unavailable) was added in this participant flow to account for patients who were randomized, but whose treatment assignment was not documented in the current data.

Participant milestones

Participant milestones
Measure	Unavailable Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. "Completed" patients were those who had documented response or follow-up data in the current dataset.	Chemoradiation Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. "Completed" patients were those who had documented response or follow-up data in the current dataset.	Chemoradiation + Hyperthermia Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. "Completed" patients were those who had documented response or follow-up data in the current dataset.
Overall Study STARTED	13	49	39
Overall Study COMPLETED	9	38	32
Overall Study NOT COMPLETED	4	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Unavailable Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. "Completed" patients were those who had documented response or follow-up data in the current dataset.	Chemoradiation Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. "Completed" patients were those who had documented response or follow-up data in the current dataset.	Chemoradiation + Hyperthermia Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. "Completed" patients were those who had documented response or follow-up data in the current dataset.
Overall Study Missing Data	4	11	7

Baseline Characteristics

Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=101 Participants Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
Age Continuous	50.25 years STANDARD_DEVIATION 12.15 • n=5 Participants
Sex: Female, Male Female	101 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months from start of therapy

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 Years

Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 years

Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 5 Years

Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.

Outcome measures

Outcome data not reported

Adverse Events

Overall Study

Serious events: 10 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall Study n=101 participants at risk Patients from both arms were combined in adverse event reporting.
Cardiac disorders Myocardial infarction	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Diarrhea	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Nausea	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Vomiting	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Immune system disorders Allergic reaction	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations Lung infection	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations Sepsis	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Reproductive system and breast disorders Pelvic pain	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Vascular disorders Thromboembolic event	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

Other adverse events

Other adverse events
Measure	Overall Study n=101 participants at risk Patients from both arms were combined in adverse event reporting.
Cardiac disorders "Cardiac disorders - Other, specify: Valvular heart disease"	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Eye disorders Blurred vision	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Abdominal pain	7.9% 8/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Constipation	14.9% 15/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Diarrhea	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Gastritis	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Mucositis oral	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Nausea	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Gastrointestinal disorders Vomiting	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
General disorders Edema limbs	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
General disorders Fatigue	8.9% 9/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
General disorders Pain	6.9% 7/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Immune system disorders Allergic reaction	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations Bronchial infection	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations "Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Cervix"	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations "Infections and infestations - Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Vulva"	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations Lung infection	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Infections and infestations Urinary tract infection	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Injury, poisoning and procedural complications Burn	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Injury, poisoning and procedural complications Fracture	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Investigations Neutrophil count decreased	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Investigations Platelet count decreased	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Investigations Weight gain	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Investigations Weight loss	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Metabolism and nutrition disorders Anorexia	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Metabolism and nutrition disorders Dehydration	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Metabolism and nutrition disorders Hypokalemia	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Metabolism and nutrition disorders Hypomagnesemia	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Musculoskeletal and connective tissue disorders Back pain	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 5/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Nervous system disorders Headache	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Nervous system disorders Syncope	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Renal and urinary disorders Cystitis noninfective	4.0% 4/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Renal and urinary disorders Urinary tract obstruction	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Renal and urinary disorders Urinary tract pain	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Reproductive system and breast disorders Pelvic pain	2.0% 2/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Reproductive system and breast disorders Vaginal discharge	3.0% 3/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Reproductive system and breast disorders Vaginal hemorrhage	6.9% 7/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders Alopecia	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders Erythema multiforme	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders Pain of skin	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders "Skin and subcutaneous tissue disorders - Other, specify"	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Skin and subcutaneous tissue disorders Urticaria	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Vascular disorders Hot flashes	4.0% 4/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Vascular disorders Hypotension	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.
Vascular disorders Thromboembolic event	0.99% 1/101 Adverse events of all toxicity grades are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

Additional Information

Dr Mark Dewhirst

Duke University Medical Center

Phone: 919 6683726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place