Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer (NCT NCT00796718)
NCT ID: NCT00796718
Last Updated: 2016-08-25
Results Overview
Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.
COMPLETED
PHASE2
62 participants
Up to 11 weeks (assessed at the time of post-treatment surgery)
2016-08-25
Participant Flow
A total of 62 participants were enrolled in the study.
Participant milestones
| Measure |
Capecitabine
Capecitabine 825 milligrams per meter square (mg/m\^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Capecitabine
Capecitabine 825 milligrams per meter square (mg/m\^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Exclusion Criteria
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Informed Consent
|
1
|
Baseline Characteristics
A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine
n=62 Participants
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 11 weeks (assessed at the time of post-treatment surgery)Population: Participants with available data.
Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.
Outcome measures
| Measure |
Capecitabine
n=50 Participants
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Percentage of Participants With Pathological Complete Response
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)Population: Participants with available data.
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Outcome measures
| Measure |
Capecitabine
n=49 Participants
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
No Response
|
77.6 percentage of participants
|
|
Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
Complete Response
|
2 percentage of participants
|
|
Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)
Partial Remission
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 15 weeks (assessed 1 month after surgery)Population: Participants with available data.
Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.
Outcome measures
| Measure |
Capecitabine
n=50 Participants
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Complete Response
|
56 percentage of participants
|
|
Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
Partial Remission
|
10 percentage of participants
|
|
Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)
No Response
|
14 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 15 weeksPopulation: All enrolled participants.
An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Capecitabine
n=62 Participants
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Percentage of Participants With Adverse Events
|
91.9 percentage of participants
|
Adverse Events
Capecitabine
Serious adverse events
| Measure |
Capecitabine
n=62 participants at risk
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Cardiac disorders
Ventricular fibrillation
|
1.6%
1/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
2/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Hemorrhoidal inflammation
|
1.6%
1/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/62 • Up to 15 weeks
All enrolled participants.
|
|
Infections and infestations
Sepsis
|
1.6%
1/62 • Up to 15 weeks
All enrolled participants.
|
Other adverse events
| Measure |
Capecitabine
n=62 participants at risk
Capecitabine 825 mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.9%
8/62 • Up to 15 weeks
All enrolled participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
5/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
8/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Diarrhea
|
33.9%
21/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
11.3%
7/62 • Up to 15 weeks
All enrolled participants.
|
|
Gastrointestinal disorders
Rectal pain
|
19.4%
12/62 • Up to 15 weeks
All enrolled participants.
|
|
General disorders
Fatigue
|
9.7%
6/62 • Up to 15 weeks
All enrolled participants.
|
|
Infections and infestations
Upper respiratory infection
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
32.3%
20/62 • Up to 15 weeks
All enrolled participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in the liver
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
|
Vascular disorders
Hypertension
|
6.5%
4/62 • Up to 15 weeks
All enrolled participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER