Trial Outcomes & Findings for Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer (NCT NCT03781323)
NCT ID: NCT03781323
Last Updated: 2024-12-13
Results Overview
* A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations. * A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring. * Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decrease in size without obtaining near or complete response. * Stable disease, in our study, will be those tumors read with RECIST criteria with a \<20% decrease in size without obtaining near or complete response. * Progressive disease will be those tumors with \>20% increase in size by RECIST version 1.1 criteria on imaging.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2024-12-13
Participant Flow
13 patients were consented, 1 failed screening
Participant milestones
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Neoadjuvant FOLFOX Therapy With Short Course Radiation and Active Surveillance in Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
n=12 Participants
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Age, Continuous
|
51.4 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Data was missing for one participant.
* A complete response will consist of a digital rectal exam with normal appearing mucosa and sigmoidoscopy/proctoscopy with scarring but no nodularity or ulcerations. * A near complete response will consist of digital rectal exam with smooth or minor mucosal abnormalities, and sigmoidoscopy/proctoscopy with small mucosal abnormalities, or superficial ulceration or erythematous scarring. * Partial response, in our study, will be those tumors read with RECIST version 1.1 criteria with a ≥20% decrease in size without obtaining near or complete response. * Stable disease, in our study, will be those tumors read with RECIST criteria with a \<20% decrease in size without obtaining near or complete response. * Progressive disease will be those tumors with \>20% increase in size by RECIST version 1.1 criteria on imaging.
Outcome measures
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
n=11 Participants
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Proportion of Patients With a Complete Clinical Response.
|
0.27 proportion or participants
|
SECONDARY outcome
Timeframe: 5 yearsWill be measured by physical exams
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsWill be measured by laboratory testing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsWill be measured by proctoscopy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsWill be measured by sigmoidoscopy
Outcome measures
Outcome data not reported
Adverse Events
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
n=12 participants at risk
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Renal and urinary disorders
acute kidney injury
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
colonic performation
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
colitis
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
ileus
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
ileal obstruction
|
8.3%
1/12 • 1 year
|
Other adverse events
| Measure |
mFOLFOX (5-Fluorouracil Leucovorin Oxaliplatin)
n=12 participants at risk
Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
FOLFOX: Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
41.7%
5/12 • 1 year
|
|
Investigations
alanine aminotransferase increase
|
8.3%
1/12 • 1 year
|
|
Investigations
alkaline phosphatase increased
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
alopecia
|
8.3%
1/12 • 1 year
|
|
Blood and lymphatic system disorders
anemia
|
25.0%
3/12 • 1 year
|
|
Metabolism and nutrition disorders
anorexia
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
anxiety
|
33.3%
4/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • 1 year
|
|
Cardiac disorders
atrial fibrillation
|
8.3%
1/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.3%
1/12 • 1 year
|
|
Blood and lymphatic system disorders
Mediport Thrombus
|
8.3%
1/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.3%
1/12 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
2/12 • 1 year
|
|
General disorders
Chills
|
25.0%
3/12 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
83.3%
10/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Depression
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
91.7%
11/12 • 1 year
|
|
Nervous system disorders
Dizziness
|
41.7%
5/12 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
2/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • 1 year
|
|
General disorders
Edema limbs
|
25.0%
3/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • 1 year
|
|
General disorders
Fatigue
|
91.7%
11/12 • 1 year
|
|
General disorders
Fever
|
8.3%
1/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Hematochezia
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Heartburn
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Abdominal Cramping
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Hypoactive Bowel Sounds
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Mouth sores
|
8.3%
1/12 • 1 year
|
|
General disorders
Cold Sensitivity in hand and throat
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
1/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
4/12 • 1 year
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • 1 year
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • 1 year
|
|
General disorders
Hypothermia
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Mediport Incision Infection
|
8.3%
1/12 • 1 year
|
|
Injury, poisoning and procedural complications
Lesion from tick bite on upper back
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Insomnia
|
16.7%
2/12 • 1 year
|
|
Infections and infestations
Lip infection
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Lung infection
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Memory impairment
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
3/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck/Jawline pain
|
8.3%
1/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
75.0%
9/12 • 1 year
|
|
Nervous system disorders
Cold Sensitivity
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Sleep Disturbance
|
8.3%
1/12 • 1 year
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
16.7%
2/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
3/12 • 1 year
|
|
Cardiac disorders
Palpitations
|
16.7%
2/12 • 1 year
|
|
Nervous system disorders
Paresthesia
|
50.0%
6/12 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
58.3%
7/12 • 1 year
|
|
Investigations
Platelet count decreased
|
33.3%
4/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • 1 year
|
|
Psychiatric disorders
Sleep Disturbance
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
8.3%
1/12 • 1 year
|
|
Reproductive system and breast disorders
Vaginal spotting
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Sepsis
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nasal Sores
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Irritant dermatitis around stoma
|
16.7%
2/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Diaphoretic
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema to fingertips
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • 1 year
|
|
Investigations
Weight loss
|
8.3%
1/12 • 1 year
|
|
Investigations
White blood cell decreased
|
8.3%
1/12 • 1 year
|
|
Injury, poisoning and procedural complications
Wound complication
|
8.3%
1/12 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place