Trial Outcomes & Findings for Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer (NCT NCT00012012)

NCT ID: NCT00012012

Last Updated: 2015-01-07

Results Overview

To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

45 participants

Primary outcome timeframe

From start of treatment to 90 days

Results posted on

2015-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy Plus Cisplatin Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.	Radiation Therapy Plus Cisplatin & Amifostine Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
Overall Study STARTED	27	18
Overall Study COMPLETED	26	15
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation Therapy Plus Cisplatin Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.	Radiation Therapy Plus Cisplatin & Amifostine Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Radiation Therapy and Cisplatin With or Without Amifostine for Patients With Stage IIIB or IVA Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy Plus Cisplatin n=26 Participants Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.	Radiation Therapy Plus Cisplatin & Amifostine n=15 Participants Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.	Total n=41 Participants Total of all reporting groups
Age, Continuous	54 years n=39 Participants	56 years n=41 Participants	55 years n=35 Participants
Sex: Female, Male Female	26 Participants n=39 Participants	15 Participants n=41 Participants	41 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants

PRIMARY outcome

Timeframe: From start of treatment to 90 days

Population: All eligible patients

Outcome measures

Outcome measures
Measure	Radiation Therapy Plus Cisplatin n=26 Participants Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)	81 percentage of participants Interval 66.0 to 96.0

PRIMARY outcome

Timeframe: From start of treatment to 90 days

Population: All eligible patients

The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.

Outcome measures

Outcome measures
Measure	Radiation Therapy Plus Cisplatin n=15 Participants Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)	13 participants

SECONDARY outcome

Timeframe: From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy Plus Cisplatin

Serious events: 20 serious events

Other events: 26 other events

Deaths: 0 deaths

Radiation Therapy Plus Cisplatin & Amifostine

Serious events: 12 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Radiation Therapy Plus Cisplatin n=26 participants at risk Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.	Radiation Therapy Plus Cisplatin & Amifostine n=15 participants at risk Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
Blood and lymphatic system disorders Packed red blood cell transfusion	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	20.0% 3/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Cardiac disorders Myocardial ischaemia	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Abdominal pain NOS	0.00% 0/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Diarrhea NOS	23.1% 6/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Gastric ulcer	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Late RT Toxicity: Small/Lg Intestine: NOS	15.4% 4/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Nausea	19.2% 5/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	33.3% 5/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Gastrointestinal disorders Vomiting NOS	19.2% 5/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	26.7% 4/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
General disorders Late RT Toxicity: Other: NOS	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
General disorders Pain-other	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	13.3% 2/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Infections and infestations Infection NOS	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Investigations Alanine aminotransferase increased	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Investigations Leukopenia NOS	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	20.0% 3/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Investigations Neutropenia	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Blood magnesium decreased	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Dehydration	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Hyperglycemia NOS	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Hypernatremia	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Hypocalcemia	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	13.3% 2/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Hypokalemia	23.1% 6/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Metabolism and nutrition disorders Hyponatremia	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	26.7% 4/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Respiratory, thoracic and mediastinal disorders Dyspnea NOS	3.8% 1/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	0.00% 0/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
Vascular disorders Thrombosis NOS	7.7% 2/26 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).	6.7% 1/15 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).