Trial Outcomes & Findings for Complete Neoadjuvant Treatment for REctal Cancer (CONTRE) (NCT NCT01363843)
NCT ID: NCT01363843
Last Updated: 2020-06-11
Results Overview
The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
approx 6 months
Results posted on
2020-06-11
Participant Flow
39 patients we enrolled, 36 completed all 8 cycles of induction modified FOLFOX6, 35 patients completed chemo-radiation, 38 patients underwent surgery.
Participant milestones
| Measure |
Study Arm Only
Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
2. Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)
Baseline characteristics by cohort
| Measure |
Study Arm
n=39 Participants
Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
2. Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: approx 6 monthsThe primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine
Outcome measures
| Measure |
Study Arm Only
n=39 Participants
Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
2. Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Incidence of Complete Resection
|
13 participants
|
SECONDARY outcome
Timeframe: approx 1 yearEvaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation. Results show number of patients who experienced a SAE. This does not mean all SAEs were deemed related to treatment. •Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed
Outcome measures
| Measure |
Study Arm Only
n=39 Participants
Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
2. Capecitabine 825 mg/m2 PO BID
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Evaluate the Toxicity of Study Therapy
|
13 Participants
|
Adverse Events
Study Arm Only
Serious events: 13 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Arm Only
n=39 participants at risk
Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Investigations
anorexia
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
angioderma/allergy
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
constipation
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dehydration
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
diarrhea
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
DVT
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
edema
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
fever
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
gastritis
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
LFTs
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
migrane/headache
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
nausea
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
neutropenia
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
numbness
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-abdominal and cramps
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-neck
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
Panic Attack
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
parasthesia
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
rash
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
renal failure
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
tingling
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
thrombocytopenia
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
thrombus formation
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
TIA
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
URI
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
UTI
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
vomiting
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
weakness
|
2.6%
1/39 • Number of events 1 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
Other adverse events
| Measure |
Study Arm Only
n=39 participants at risk
Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles
Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)
Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)
1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
2. Capecitabine
|
|---|---|
|
Investigations
Alk phos
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
Albumin
|
15.4%
6/39 • Number of events 6 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
alopecia
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
anemia
|
53.8%
21/39 • Number of events 21 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
anorexia
|
15.4%
6/39 • Number of events 6 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
anxiety
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
vision disturbances
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-bone
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
ca
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
chills
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
cold sensitivity
|
28.2%
11/39 • Number of events 11 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
constipation
|
53.8%
21/39 • Number of events 21 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
cough
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
creatinine
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dehydration
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
diarrhea
|
41.0%
16/39 • Number of events 16 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dizziness
|
15.4%
6/39 • Number of events 6 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dry skin, acne, itchiness, pruritus
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dyspnea/SOB
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
dysuria
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
edema
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
fatigue
|
79.5%
31/39 • Number of events 31 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
heartburn
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
bili
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
glucose
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
potassium
|
23.1%
9/39 • Number of events 9 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
Mg
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
Hypersensitivity rxn
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
hypertension/tach/palp
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
HTN
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
infection - general (tooth included here)
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
insomnia
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
LFTs
|
25.6%
10/39 • Number of events 10 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
light headedness
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
mood alteration
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
mucositis/oral thrush
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
M/A
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
nausea
|
64.1%
25/39 • Number of events 25 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
neuropathy
|
48.7%
19/39 • Number of events 19 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
neutropenia
|
30.8%
12/39 • Number of events 12 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain - mouth
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-abdominal and cramps
|
17.9%
7/39 • Number of events 7 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-general
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
pain-rectal
|
17.9%
7/39 • Number of events 7 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
palpatations/ tachycardia
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
proteinuria
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
rash
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
rectal bleeding
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
taste alteration
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
thrombocytopenia
|
46.2%
18/39 • Number of events 18 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
uric acid
|
5.1%
2/39 • Number of events 2 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
urinary frequency
|
7.7%
3/39 • Number of events 3 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
vomiting
|
20.5%
8/39 • Number of events 8 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
WBC
|
10.3%
4/39 • Number of events 4 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
|
Investigations
weight loss
|
12.8%
5/39 • Number of events 5 • From signing consent to post completion of induction (approximately 4 months)
induction AEs and SAEs included for reporting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place