Trial Outcomes & Findings for A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer (NCT NCT00226941)
NCT ID: NCT00226941
Last Updated: 2017-12-08
Results Overview
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a \< 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
10 weeks
Results posted on
2017-12-08
Participant Flow
Participant milestones
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by subject - toxicity
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawn by investigator - unrelated AE
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=7 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Histology
Adenocarcinoid Tumor
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Histology
Adenocarcinoma, Nos
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Histology
Adenosarcoma
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: All participants were formally part of the phase 1 portion of this study.
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a \< 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=7 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group
|
10 DLTs
|
2 DLTs
|
0 DLTs
|
0 DLTs
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: All participants were formally part of the phase 1 portion of this study.
Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a \< 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=7 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Dose-limiting Toxicity (DLT) - Number of Participants Affected
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 to 14 weeks after radiotherapyPopulation: This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.
After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Pathologic Response Rate
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 to 14 weeks after radiotherapyPopulation: This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.
Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Tumor Downstaging at Surgical Resection
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This study was terminated before all patients reached 5 years from the date of surgical resection. Only patients that progressed are reported, and since no patients progressed in Group 2, median and range are not reportable.
Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=2 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=1 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=3 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Time-to-Progression (TTP)
|
1.4 years
Interval 0.8 to 2.0
|
—
|
3.0 years
Interval 3.0 to 3.0
|
3.9 years
Interval 0.2 to 5.0
|
SECONDARY outcome
Timeframe: 72 monthsPopulation: This outcome is defined per protocol as study phase 2, which did not occur. However, data are provided for phase 1 participants, for completeness. This study was terminated before all patients reached 5 years on study. Some patients are reported as the last known alive date.
Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
59.7 months
Standard Deviation 0.7
|
57.0 months
Standard Deviation 5.8
|
54.4 months
Standard Deviation 11.1
|
53.7 months
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This outcome is defined per protocol as study phase 2, which did not occur. However, data are available from the phase 1 participants (only), and are provided for completeness. This study was terminated before all patients reached 5 years from study entry. Only patients known to be alive at 5 years are reported.
Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment.
Outcome measures
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=5 Participants
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Survival at 5 Years
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
Group A - Cetuximab + Capecitabine-800 + XRT
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B - Cetuximab + Capecitabine-1000 + XRT
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=7 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Decrease in lung volumes with increased bibasilar atelectasis
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Small bowel obstruction-Ileus
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
3/6 • Number of events 4 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
50.0%
2/4 • Number of events 2 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dehydration
|
50.0%
3/6 • Number of events 3 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 8 • 5 years
|
33.3%
2/6 • Number of events 7 • 5 years
|
0.00%
0/4 • 5 years
|
71.4%
5/7 • Number of events 12 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nausea
|
100.0%
6/6 • Number of events 11 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
Other adverse events
| Measure |
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100
n=6 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23
|
Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85
n=6 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23
|
Group A - Cetuximab + Capecitabine-800 + XRT
n=4 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
|
Group B - Cetuximab + Capecitabine-1000 + XRT
n=7 participants at risk
* Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic reaction
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Anorexia
|
66.7%
4/6 • Number of events 4 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
75.0%
3/4 • Number of events 3 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Infections and infestations
Pain
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Reproductive system and breast disorders
Libido
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Cardiac disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Edema
|
16.7%
1/6 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Immune system disorders
Fatigue
|
66.7%
4/6 • Number of events 7 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
50.0%
2/4 • Number of events 2 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Investigations
Insomnia
|
50.0%
3/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Rigors
|
33.3%
2/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Infections and infestations
Fever
|
66.7%
4/6 • Number of events 4 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage in rectum
|
50.0%
3/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Investigations
Syncope
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Nervous system disorders
Depression
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Backache
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bilateral jaw pain
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Distension
|
50.0%
3/6 • Number of events 3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Bloody stool
|
0.00%
0/6 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
57.1%
4/7 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
Bloody rectum
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Candidal infection
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 3 • 5 years
|
0.00%
0/7 • 5 years
|
|
General disorders
Chest tightness
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Cold sensitivity
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Constipation, alternating with diarrhea
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 3 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin cracking
|
16.7%
1/6 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
0.00%
0/4 • 5 years
|
42.9%
3/7 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Cramping
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Cuticle dryness
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
General disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 10 • 5 years
|
33.3%
2/6 • Number of events 7 • 5 years
|
0.00%
0/4 • 5 years
|
57.1%
4/7 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
Diarrhea with cramping
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Elevated alanine aminotransferase (ALT)
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Elevated aspartate aminotransferase (AST)
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema at incision
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Flatus
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Flu-like symptoms
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Flushing
|
16.7%
1/6 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash, follicular, chest and back
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Pain, groin
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hand and foot syndrome
|
33.3%
2/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
50.0%
2/4 • Number of events 2 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
33.3%
2/6 • Number of events 2 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Endocrine disorders
Hypomagnesemia
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Induration
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Left arm numbness
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Injury, poisoning and procedural complications
Pain, left knee
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Abnormal liver function test (LFT)
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Injury, poisoning and procedural complications
Pain, lower back
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Low grade fever
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Blood and lymphatic system disorders
Hematocrit decreased
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
General disorders
Migraine
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • Number of events 14 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
50.0%
2/4 • Number of events 2 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Nocturia
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Pain with bowel movements
|
66.7%
4/6 • Number of events 4 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 2 • 5 years
|
42.9%
3/7 • Number of events 3 • 5 years
|
|
General disorders
Weight loss
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 4 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection, urinary track (UTI)
|
16.7%
1/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Infection, upper respiratory tract
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Pain, umbilical cord protrusion
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Tingling, fingertips
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Tingling, cheeks
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
General disorders
Taste disturbance
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin dryness
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Blood in stool, scant
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Nervous system disorders
Neuropathy, right arm
|
33.3%
2/6 • Number of events 4 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Gastrointestinal disorders
Reflux
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
General disorders
Infection, rectal-anal
|
50.0%
3/6 • Number of events 3 • 5 years
|
83.3%
5/6 • Number of events 6 • 5 years
|
50.0%
2/4 • Number of events 2 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Radiation demititis
|
33.3%
2/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/7 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
6/6 • Number of events 11 • 5 years
|
100.0%
6/6 • Number of events 10 • 5 years
|
100.0%
4/4 • Number of events 7 • 5 years
|
71.4%
5/7 • Number of events 12 • 5 years
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 2 • 5 years
|
66.7%
4/6 • Number of events 5 • 5 years
|
25.0%
1/4 • Number of events 1 • 5 years
|
28.6%
2/7 • Number of events 2 • 5 years
|
|
General disorders
Pain (t11-12 level)
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Renal and urinary disorders
Pain, bladder and testes
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
0.00%
0/7 • 5 years
|
|
Ear and labyrinth disorders
Pain, middle ear
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain, throat
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/4 • 5 years
|
14.3%
1/7 • Number of events 1 • 5 years
|
Additional Information
George Albert Fisher, Jr, MD, PhD; Colleen Haas Chair, School of Medicine
Stanford Cancer Institute, Stanford University
Phone: 650-723-2990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place