Trial Outcomes & Findings for Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial (NCT NCT03690921)
NCT ID: NCT03690921
Last Updated: 2023-06-29
Results Overview
Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Acute physician reported toxicity from start of treatment 12 weeks post-treatment
Results posted on
2023-06-29
Participant Flow
Recruitment occurred from 11/5/2018 until 6/3/2022. Recruitment occurred in radiation oncology clinics at UT MD Anderson Cancer Center.
There were no enrolled patients excluded prior to assignment to arms or groups.
Participant milestones
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
Baseline characteristics by cohort
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
70 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Acute physician reported toxicity from start of treatment 12 weeks post-treatmentPopulation: All patients with 12 week follow up.
Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Acute Toxicity
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All patients with 12 weeks follow up
Number (percentage) patients who achieved a complete clinical response of their disease by 12 weeks after chemoradiation.
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Complete Response at 12 Weeks
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients with 24 month follow up
Patients alive without evidence of local progression 24 months after chemoradiation.
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Local Progression Free Survival at 24 Months
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients with 24 month follow up
Patients alive without evidence of distant metastases 24 months after chemoradiation.
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Distant Metastasis-free Survival at 24 Months.
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients with 24 month follow up
Patients alive 24 months after chemoradiation.
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Overall Survival at 24 Months
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All patients with 24 week follow up
Number (percentage) patients who achieved a complete clinical response of their disease by 24 weeks after chemoradiation.
Outcome measures
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 Participants
Intensity Modulated Proton Therapy with concurrent chemotherapy as definitive treatment for non-metastatic anal squamous cell carcinoma.
|
|---|---|
|
Complete Response at 24 Weeks
|
6 Participants
|
Adverse Events
IMPT for Anal Cancer (Single Arm Trial)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMPT for Anal Cancer (Single Arm Trial)
n=8 participants at risk
Acute physician reported toxicity from start of treatment 12 weeks post-treatment.
|
|---|---|
|
Gastrointestinal disorders
Abnormal bowel habits
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Absolute eosinophil decrease
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Absolute lymphocyte decrease
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Absolute monocyte decrease
|
50.0%
4/8 • Number of events 4 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Absolute neutrophil decrease
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Absolute neutrophil increase
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
Acute kidney disease
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increase
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Anal fissure
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Anal bleeding
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8 • Number of events 7 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Anorectal pain
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
AST Increased
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Nervous system disorders
Bilateral foot pain
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Nervous system disorders
Binaural tinnitus
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
Bladder incontinence
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Bowel incontinence
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Bowel urgency
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
BUN increase
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Carbon Dioxide Decreased
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Chest pain (non-cardiac)
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Chloride level increase
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Chloride level decrease
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
Creatinine increased
|
62.5%
5/8 • Number of events 5 • Assessed up to 2 years
CTCAE v4
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
General disorders
Difficulty with sleep
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Skin and subcutaneous tissue disorders
Dyspaurenia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Epigastric pain
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
High TSH
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hot flashes
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Increased LDH
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Low TSH
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Musculoskeletal and connective tissue disorders
Lower extremity edema
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash of torso
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Monocyte count increase
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Mucous discharge
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8 • Number of events 5 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Nosebleed
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
General disorders
PICC line pain
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
25.0%
2/8 • Number of events 2 • Assessed up to 2 years
CTCAE v4
|
|
Metabolism and nutrition disorders
Total protein decreased
|
37.5%
3/8 • Number of events 3 • Assessed up to 2 years
CTCAE v4
|
|
General disorders
Ear fullness
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Cardiac disorders
Troponin I increased
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Renal and urinary disorders
Urinary Urgency
|
12.5%
1/8 • Number of events 1 • Assessed up to 2 years
CTCAE v4
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
50.0%
4/8 • Number of events 4 • Assessed up to 2 years
CTCAE v4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place