Trial Outcomes & Findings for Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer (NCT NCT00324415)
NCT ID: NCT00324415
Last Updated: 2025-05-30
Results Overview
Patients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
3 years following completion of therapy
Results posted on
2025-05-30
Participant Flow
Participant milestones
| Measure |
Combined Modality Therapy
Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Baseline characteristics by cohort
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years following completion of therapyPatients will be classified into two groups for purposes of primary endpoint analysis: failure or no failure at 3 years (in the primary analysis, patients lost to follow-up prior to 3 years will be considered failures). For the secondary endpoint of objective response, patients will be classified as responders
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Locoregional Failure Rate at 3 Years
LRF rate by including censored patients treated as failures
|
42 percentage of participants
Interval 28.0 to 56.0
|
|
Locoregional Failure Rate at 3 Years
LRF rate as per Kaplan-Meier estimate
|
20 percentage of participants
Interval 10.0 to 37.0
|
SECONDARY outcome
Timeframe: 1 yearProgression-free survival at 1 year is the percentage of patients who are alive and have not experienced progressive disease, defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Progression-free Survival
|
87.3 percentage of participants
Interval 72.1 to 94.5
|
SECONDARY outcome
Timeframe: 1 yearPercentage of participants who are alive and have not experienced progressive disease and have not relapsed
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Relapse-free Survival
|
83.1 percentage of participants
Interval 67.8 to 91.6
|
SECONDARY outcome
Timeframe: 1 yearPercentage of participants who are alive and have not had a colostomy
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Colostomy-free Survival at 1 Year
|
92.4 percentage of participants
Interval 78.3 to 97.5
|
SECONDARY outcome
Timeframe: 1 yearPercentage of participants who are alive at one year
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Overall Survival
|
92.8 percentage of participants
Interval 79.4 to 97.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The number of participants analyzed is the number of participants for whom quality of life questionnaires were completed at one year.
EORTC QLQ-C30 Global Score at 1 year. The EORTC QLQ-C30 is a validated questionnaire that evaluates quality of life. The global score is an overall score for quality of life that ranges from 0 to 100. Higher scores indicate between quality of life
Outcome measures
| Measure |
Combined Modality Therapy
n=29 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Quality of Life EORTC Global Score at 1 Year
|
78.9 units on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: 90 days following treatment discontinuationDelayed toxicities are defined as toxicities that occur over 90 days following treatment completion
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Number of Delayed Toxicities
|
5 events
|
SECONDARY outcome
Timeframe: 1 year following treatment discontinuationPopulation: The number of participants analyzed is the number for whom absolute CD4 count data were available at baseline at at 1 year after study completion
Change in absolute CD4 counts from start of treatment to 1 year after completion of study treatment
Outcome measures
| Measure |
Combined Modality Therapy
n=38 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment
|
102 cells/mm3
Interval -403.0 to 669.0
|
SECONDARY outcome
Timeframe: 1 year following treatment discontinuationIncidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Incidence of Opportunistic Illnesses
|
4 participants
|
SECONDARY outcome
Timeframe: 3 years following treatment discontinuationNumber of participants with complete and partial responses based on the RECIST criteria
Outcome measures
| Measure |
Combined Modality Therapy
n=45 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Objective Response Rate (Complete and Partial)
|
30 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: Participants with available HPV status data
Descriptive statistics will be used to describe the types of HPV found in baseline anal swabs and tissue biopsies. Proportion of cases with each type will be summarized
Outcome measures
| Measure |
Combined Modality Therapy
n=30 Participants
cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
|
|---|---|
|
Count of Participants by Type of HPV at Baseline
HPV 16
|
16 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 6
|
9 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 11
|
9 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 18
|
5 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 31
|
5 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 33
|
3 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 32
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 35
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 45
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 54
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 53
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 69
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 72
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 73
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 82
|
3 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 68
|
3 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 51
|
2 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 52
|
2 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 26
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 30
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 56
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 58
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 86
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 87
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
HPV 97
|
1 Participants
|
|
Count of Participants by Type of HPV at Baseline
Mixed
|
1 Participants
|
Adverse Events
Combined Modality Therapy
Serious events: 27 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Modality Therapy
n=45 participants at risk
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Anal fistula
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Anal mucositis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Anal pain
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
17.8%
8/45 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Oral mucositis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
General disorders
death NOS
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Anorectal infection
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Infections and infestations
Lung infection
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Meningitis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Scrotal infection
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Wound infection
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Radiation reaction (dermatologic)
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Investigations
Creatinine increased
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Investigations
Platelet count decreased
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Investigations
White blood count decreased
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Acidosis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
9/45 • Number of events 9 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
9/45 • Number of events 9 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Nervous system disorders
Cognitive disturbance
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Nervous system disorders
Syncope
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
melena
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection with grade 3 or 4 neutrophils
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
Infections and infestations
Lung pneumonia
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Infections and infestations
Toxoplasmosis with Hydrocephalus
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.2%
1/45 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other skin disorder
|
4.4%
2/45 • Number of events 2 • 3 years
|
|
Infections and infestations
Cellulitis
|
2.2%
1/45 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Combined Modality Therapy
n=45 participants at risk
cisplatin, 5-flourouruacil, and irradiation plus cetuximab
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.1%
14/45 • Number of events 26 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
15.6%
7/45 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
Anal pain
|
22.2%
10/45 • Number of events 14 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
48.9%
22/45 • Number of events 38 • 3 years
|
|
Gastrointestinal disorders
Other GI disorders
|
20.0%
9/45 • Number of events 21 • 3 years
|
|
Gastrointestinal disorders
Oral mucositis
|
22.2%
10/45 • Number of events 23 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
26.7%
12/45 • Number of events 18 • 3 years
|
|
Gastrointestinal disorders
Proctitis
|
11.1%
5/45 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
6.7%
3/45 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
7/45 • Number of events 8 • 3 years
|
|
General disorders
Fatigue
|
37.8%
17/45 • Number of events 18 • 3 years
|
|
General disorders
Fever
|
11.1%
5/45 • Number of events 5 • 3 years
|
|
Blood and lymphatic system disorders
Other blood and lymphatic disorders
|
11.1%
5/45 • Number of events 7 • 3 years
|
|
General disorders
Other general disorders
|
13.3%
6/45 • Number of events 7 • 3 years
|
|
General disorders
Pain
|
6.7%
3/45 • Number of events 4 • 3 years
|
|
Infections and infestations
Anorectal infection
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Infections and infestations
Other infections
|
8.9%
4/45 • Number of events 6 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
24.4%
11/45 • Number of events 16 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
8.9%
4/45 • Number of events 4 • 3 years
|
|
Injury, poisoning and procedural complications
Aspartate aminotransferase increased
|
8.9%
4/45 • Number of events 4 • 3 years
|
|
Investigations
Blood bilirubin increased
|
6.7%
3/45 • Number of events 6 • 3 years
|
|
Investigations
Neutrophil count decreased
|
22.2%
10/45 • Number of events 18 • 3 years
|
|
Investigations
Platelet count decreased
|
28.9%
13/45 • Number of events 17 • 3 years
|
|
Investigations
Weight loss
|
24.4%
11/45 • Number of events 12 • 3 years
|
|
Investigations
White blood cell decreased
|
24.4%
11/45 • Number of events 34 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
9/45 • Number of events 11 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
22.2%
10/45 • Number of events 11 • 3 years
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
8.9%
4/45 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.6%
7/45 • Number of events 9 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
10/45 • Number of events 17 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
11.1%
5/45 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.6%
7/45 • Number of events 11 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Nervous system disorders
Anxiety
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Nervous system disorders
Depression
|
8.9%
4/45 • Number of events 4 • 3 years
|
|
Nervous system disorders
Insomnia
|
8.9%
4/45 • Number of events 4 • 3 years
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
6.7%
3/45 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
6/45 • Number of events 6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
5/45 • Number of events 5 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.9%
4/45 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
3/45 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
26.7%
12/45 • Number of events 15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other skin disorders
|
26.7%
12/45 • Number of events 20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
3/45 • Number of events 5 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place