Trial Outcomes & Findings for Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer (NCT NCT04380337)
NCT ID: NCT04380337
Last Updated: 2025-02-25
Results Overview
Proportion of patients who achieve a clinical complete response following therapy, expressed as a number and proportion without dispersion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
8 (+/-4 ) weeks following completion of RT and chemotherapy, an average of 9 months
Results posted on
2025-02-25
Participant Flow
38 patients were enrolled, but 1 withdrew prior to treatment start and was thus "replaced". We had 37 patients initiate treatment on study and be evaluable for primary outcome.
Participant milestones
| Measure |
Radiation/FOLFOXIRI
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer
Baseline characteristics by cohort
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 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
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 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
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 (+/-4 ) weeks following completion of RT and chemotherapy, an average of 9 monthsProportion of patients who achieve a clinical complete response following therapy, expressed as a number and proportion without dispersion.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Clinical Complete Response (cCR)
|
0.24 Proportion of Participants
Interval 0.105 to 0.381
|
SECONDARY outcome
Timeframe: 8 (+/- 4) weeks following completion of RT and chemotherapy, an average of 3 monthsToxicity defined as non-hematologic grade 4 adverse events using CTCAE v5 or higher toxicity at least possibly related to treatment, and assessed up to 3 months after completion of radiotherapy (RT) and chemotherapy.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Number of Participants With Toxicity
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)Population: All patients managed with an organ preservation approach.
Local regrowth is defined as the presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology, expressed as a percentage with its 95% confidence interval.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=18 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Local Regrowth Rate
|
50 Percentage of participants
Interval 26.0 to 74.0
|
SECONDARY outcome
Timeframe: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)Population: All participants who initiated the RT and chemotherapy regimen (intent-to-treat population) were included in the analysis.
DFS defined as the time from the start date of RT to the date of the first documented progression or death due to any cause assessed up to 2 years after completion of chemotherapy. Patients will be censored at the last date of follow-up if lost to follow-up prior to two years, expressed as a median with interquartile range.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Disease Free Survival (DFS)
|
22 months
Interval 18.0 to 28.0
|
SECONDARY outcome
Timeframe: 22 (+/- 2) months following completion of RT and chemotherapy, an average of 24 months (2 years)Population: All participants who initiated the RT and chemotherapy regimen (intent-to-treat population) were included in the analysis.
Colostomy-free survival defined as the time from the start date of RT to the date of colostomy or death due to any cause assessed up to 2 years after completion of chemotherapy, expressed as a median with interquartile range. Patients will be censored at the last date of follow-up if lost to follow-up prior to two years.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Colostomy-free Survival
|
11 months
Interval 8.0 to 18.0
|
SECONDARY outcome
Timeframe: 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 yearsPopulation: All participants who initiated the RT and chemotherapy regimen (intent-to-treat population) were included in the analysis.
OS defined as death from any cause from start date of RT until death, study completion, or loss to follow-up, whichever occurs first. This will be reported as median survival time with interquartile range.
Outcome measures
| Measure |
Radiation/FOLFOXIRI
n=37 Participants
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Overall Survival (OS)
|
27 months
Interval 19.0 to 31.0
|
Adverse Events
Radiation/FOLFOXIRI
Serious events: 25 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Radiation/FOLFOXIRI
n=37 participants at risk
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Gastrointestinal disorders
Lower GI Hemorrhage
|
2.7%
1/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
Sepsis
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Syncope
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Vasovagal Reaction
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
ALT Increase
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
Catheter Related Infection
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
Enterocolitis infectious
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Hyperglycemia
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
Hypertension
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
abcess
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
Myelitis
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
Pelvic Infection
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Presyncope
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
stoma
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
Thromboembolic Event
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment Related Secondary Malignancy
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Vasovagal reaction
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Lymphocyte count decrease
|
27.0%
10/37 • Number of events 11 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Rectal Pain
|
8.1%
3/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Neutrophil count decrease (neutropenia)
|
10.8%
4/37 • Number of events 7 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Diarrhea
|
13.5%
5/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
WBC decrease
|
8.1%
3/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Anemia
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Proctitis
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
Other adverse events
| Measure |
Radiation/FOLFOXIRI
n=37 participants at risk
Treatment comprised of 6 daily fractions of radiotherapy at 5 Gy per fraction followed by 4 months of FOLFOXIRI.
|
|---|---|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
51.4%
19/37 • Number of events 25 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
ALKALINE PHOSPHATASE INCREASE
|
70.3%
26/37 • Number of events 33 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.9%
17/37 • Number of events 17 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
ANAL FISSURE
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Blood and lymphatic system disorders
Anemia
|
81.1%
30/37 • Number of events 42 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.2%
6/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
ANOSMIA
|
8.1%
3/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
37.8%
14/37 • Number of events 18 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
BLOATING
|
16.2%
6/37 • Number of events 9 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
BLOOD BILIRUBIN INCREASE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Eye disorders
BLURRED VISION
|
10.8%
4/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
General Disorders - other, body ache
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - other, anorectal spasm
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
CHILLS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
General Disorders - other, COLD LIKE SYMPTOMS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
COLITIS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Constipation
|
37.8%
14/37 • Number of events 18 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.2%
6/37 • Number of events 9 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
CREATININE INCREASE
|
5.4%
2/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
CYSTIS NONINFECTIVE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Diarrhea
|
70.3%
26/37 • Number of events 69 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
DIZZINESS
|
16.2%
6/37 • Number of events 7 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Eye disorders
DRY EYE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Dry mouth
|
13.5%
5/37 • Number of events 6 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
DYSARTHRIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
DYSGEUSIA
|
35.1%
13/37 • Number of events 21 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
21.6%
8/37 • Number of events 14 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.4%
2/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
DYSURIA
|
18.9%
7/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
EDEMA LIMBS
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
8.1%
3/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Eye disorders
EYE DISORDERS-- OTHER PERIPHERAL VISION LOSS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
FALL
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
Fatigue
|
89.2%
33/37 • Number of events 89 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
13.5%
5/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
FEVER
|
8.1%
3/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
FLATULENCE
|
18.9%
7/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
FLU-LIKE SYMPTOMS
|
8.1%
3/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
FLUSHING
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
13.5%
5/37 • Number of events 7 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
GI DISORDER - DYSCHEZIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
GI DISORDER - FOOD SENSITIVITIES RESULTING IN DIARRHEA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
GI DISORDERS - OTHER, TENESMUS
|
8.1%
3/37 • Number of events 6 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Headache
|
24.3%
9/37 • Number of events 13 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
HEMATURIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - OTHER, HEMOPYTSIS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
HEMORRHOIDAL HEMORRHAGE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
5.4%
2/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
24.3%
9/37 • Number of events 18 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
HOT FLASHES
|
2.7%
1/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
8.1%
3/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
16.2%
6/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPERLIPIDEMIA
|
5.4%
2/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
2.7%
1/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
HYPERTENSION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
16.2%
6/37 • Number of events 10 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
HYPOTENSION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
INFUSION RELATED REACTION
|
27.0%
10/37 • Number of events 15 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
INJURY, POISIONING AND PROCEDURAL COMPLICATIONS - OTHER, INCISIONAL HERNIA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Psychiatric disorders
INSOMNIA
|
18.9%
7/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
LOCALIZED EDEMA (FEET)
|
2.7%
1/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Lymphocyte count decrease
|
62.2%
23/37 • Number of events 36 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
MALAISE
|
5.4%
2/37 • Number of events 6 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
29.7%
11/37 • Number of events 15 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
24.3%
9/37 • Number of events 19 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Nausea
|
89.2%
33/37 • Number of events 115 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER - JAW CLAUDICATION
|
13.5%
5/37 • Number of events 11 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Neutrophil count decrease
|
13.5%
5/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, BLASTOCYSTIS HOMINIS AND ENTAMOEBA COLI CYSTS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications - other, OSTOMY LEAK
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Pain - Abdominal
|
43.2%
16/37 • Number of events 23 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Pain - ANAL
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
Pain - AT PORT SITE
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
Pain - AT SURGICAL SITE
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
18.9%
7/37 • Number of events 7 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
Pain - BILATERAL ARMS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain - BONE
|
16.2%
6/37 • Number of events 6 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Ear and labyrinth disorders
Pain - EAR
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain - EXTREMITY
|
10.8%
4/37 • Number of events 5 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Eye disorders
Pain - EYE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain - FLANK
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Musculoskeletal and connective tissue disorders
Pain - NECK
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Pain - ORAL
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Reproductive system and breast disorders
Pain - PERIANAL
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Pain - Rectal
|
43.2%
16/37 • Number of events 21 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
Pain - SCALP
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
Pain - SHOULDER
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
General disorders
PAIN AT SURGICAL SITE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Cardiac disorders
PALPITATIONS
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
PAPULOPUSTULAR RASH
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Paresthesia
|
91.9%
34/37 • Number of events 124 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
56.8%
21/37 • Number of events 32 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Eye disorders
PHOTOPHOBIA
|
5.4%
2/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
Platelet count decrease
|
59.5%
22/37 • Number of events 29 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other, PRESSURE AT TESTICULAR AREA
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
PRESYNCOPE
|
5.4%
2/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Proctitis
|
62.2%
23/37 • Number of events 28 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
RECTAL ANASTOMOTIC LEAK
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
32.4%
12/37 • Number of events 13 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Reproductive system and breast disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY MENSTRUAL SPOTTING
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Psychiatric disorders
RESTLESSNESS
|
2.7%
1/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders - Other, LABIA DISCOMFORT
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER,TWO FEET ONE HAND SYNDROME (TFOHS)
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
8.1%
3/37 • Number of events 3 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - other, STOOL URGENCY
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
THRUSH
|
10.8%
4/37 • Number of events 8 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Ear and labyrinth disorders
TINNITUS
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Nervous system disorders
TREMOR
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
18.9%
7/37 • Number of events 7 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
10.8%
4/37 • Number of events 4 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.4%
2/37 • Number of events 2 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Renal and urinary disorders
URINARY URGENCY
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
VAGINAL INFECTION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Gastrointestinal disorders
VOMITING
|
45.9%
17/37 • Number of events 41 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
WBC decrease
|
51.4%
19/37 • Number of events 30 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
WEIGHT GAIN
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Investigations
WEIGHT LOSS
|
37.8%
14/37 • Number of events 15 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
|
Infections and infestations
WOUND INFECTION
|
2.7%
1/37 • Number of events 1 • 27 (+/- 4) months following completion of RT and chemotherapy, an average of 2.25 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place