Trial Outcomes & Findings for Preoperative CRT With or Without Induction Chemotherapy for Rectal Cancer With Liver Metastases (NCT NCT01643070)
NCT ID: NCT01643070
Last Updated: 2025-02-25
Results Overview
R0 = complete resection with grossly and microscopically negative margins of resection; R1 =grossly negative but microscopically positive margins of resection; R2 = grossly and microscopically positive margins of resection
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)
Results posted on
2025-02-25
Participant Flow
Between March 2010 and May 2014, a total of 38 patients from 3 centers in Korea were enrolled. They underwent random assignment and 18 patients were assigned to arm A and 20 to arm B. The cutoff date for this report was March 15, 2015. Baseline characteristics of these patients are presented in Table 1, and they were well balanced between the 2 arms. The median number of LM was 2 and cT3N+ was the most common clinical disease stage in both arms.
Participant milestones
| Measure |
Induction XELOX
Induction XELOX followed by XELOX-RT
Capecitabine, Oxaliplatin: Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.
Radiotherapy: Preoperative radiotherapy, 5040 cGy with 28 fractions
|
XELOX RT
Concurrent XELOX-RT
Capecitabine, Oxaliplatin: Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.
Radiotherapy: Preoperative radiotherapy, 5040 cGy with 28 fractions
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
XELOX-RT Received
|
15
|
0
|
|
Overall Study
Underwent Surgery
|
16
|
19
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Induction XELOX
Induction XELOX followed by XELOX-RT
Capecitabine, Oxaliplatin: Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.
Radiotherapy: Preoperative radiotherapy, 5040 cGy with 28 fractions
|
XELOX RT
Concurrent XELOX-RT
Capecitabine, Oxaliplatin: Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.
Radiotherapy: Preoperative radiotherapy, 5040 cGy with 28 fractions
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Pregressive disease
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years), median (range)
|
60 years
n=18 Participants
|
56 years
n=20 Participants
|
58 years
n=38 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=18 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=18 Participants
|
19 Participants
n=20 Participants
|
34 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Perfomance status (ECOG PS)
0
|
0 Participants
n=18 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=38 Participants
|
|
Perfomance status (ECOG PS)
1
|
18 Participants
n=18 Participants
|
15 Participants
n=20 Participants
|
33 Participants
n=38 Participants
|
|
Distance of the primary tumor from the anal verge
≤ 4 cm
|
6 Participants
n=18 Participants
|
13 Participants
n=20 Participants
|
19 Participants
n=38 Participants
|
|
Distance of the primary tumor from the anal verge
> 4 and ≤ 8 cm
|
10 Participants
n=18 Participants
|
7 Participants
n=20 Participants
|
17 Participants
n=38 Participants
|
|
Distance of the primary tumor from the anal verge
> 8 cm
|
2 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=38 Participants
|
|
Tumor differentiation
Well differentiated
|
3 Participants
n=18 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=38 Participants
|
|
Tumor differentiation
Moderately differentiated
|
13 Participants
n=18 Participants
|
16 Participants
n=20 Participants
|
29 Participants
n=38 Participants
|
|
Tumor differentiation
Poorly differentiated/signet ring cell/mucinous
|
0 Participants
n=18 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=38 Participants
|
|
Tumor differentiation
Undetermined
|
2 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=38 Participants
|
|
Clinical T Stage
cT3
|
12 Participants
n=18 Participants
|
16 Participants
n=20 Participants
|
28 Participants
n=38 Participants
|
|
Clinical T Stage
cT4
|
6 Participants
n=18 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=38 Participants
|
|
Clinical N Stage
cN0
|
1 Participants
n=18 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=38 Participants
|
|
Clinical N Stage
cN1
|
5 Participants
n=18 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=38 Participants
|
|
Clinical N Stage
cN2
|
12 Participants
n=18 Participants
|
15 Participants
n=20 Participants
|
27 Participants
n=38 Participants
|
|
Number of liver metastases
1 metastases
|
6 Participants
n=18 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=38 Participants
|
|
Number of liver metastases
2 metastases
|
4 Participants
n=18 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=38 Participants
|
|
Number of liver metastases
≥3 metastases
|
8 Participants
n=18 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=38 Participants
|
|
Number of liver metastases
1
|
6 Participants
n=18 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=38 Participants
|
|
Number of liver metastases
2
|
4 Participants
n=18 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=38 Participants
|
|
Number of liver metastases
≥3
|
8 Participants
n=18 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=38 Participants
|
|
Largest size of liver metastases (cm), median (range)
|
1.8 cm
n=18 Participants
|
2.4 cm
n=20 Participants
|
2.1 cm
n=38 Participants
|
|
Carcinoembryonic antigen (ug/ml), median (range)
|
7.4 ng/ml
n=18 Participants
|
6.9 ng/ml
n=20 Participants
|
7.15 ng/ml
n=38 Participants
|
PRIMARY outcome
Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)R0 = complete resection with grossly and microscopically negative margins of resection; R1 =grossly negative but microscopically positive margins of resection; R2 = grossly and microscopically positive margins of resection
Outcome measures
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
|---|---|---|
|
Quality of Surgery for Primary Tumor
Surgery not performed
|
2 Participants
|
1 Participants
|
|
Quality of Surgery for Primary Tumor
R0
|
15 Participants
|
19 Participants
|
|
Quality of Surgery for Primary Tumor
R1
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)R0 = complete resection with grossly and microscopically negative margins of resection; R1 =grossly negative but microscopically positive margins of resection; R2 = grossly and microscopically positive margins of resection
Outcome measures
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
|---|---|---|
|
Quality of Surgery for Liver Metastases
Surgery not performed
|
2 Participants
|
1 Participants
|
|
Quality of Surgery for Liver Metastases
R0
|
11 Participants
|
12 Participants
|
|
Quality of Surgery for Liver Metastases
R0 with intraoperative Rdiofrequency ablation
|
3 Participants
|
2 Participants
|
|
Quality of Surgery for Liver Metastases
R1
|
1 Participants
|
3 Participants
|
|
Quality of Surgery for Liver Metastases
R2
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)synchronous complete R0 resection rate, R0 = complete resection with grossly and microscopically negative margins of resection
Outcome measures
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
|---|---|---|
|
R0 Resection Rate of Both the Primary Tumor and Livermetastases
|
77.8 percentage of patients
Interval 58.6 to 97.0
|
70.0 percentage of patients
Interval 49.9 to 90.1
|
SECONDARY outcome
Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)The pathologic stage (ypT or N) was recorded according to the International Union Against Cancer TNM system. Pathologic complete response (ypCR) was defined as the absence of viable tumor cells in the surgical specimens, of the primary tumor (ypT0).
Outcome measures
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
|---|---|---|
|
Pathologic Complete Response Rate of Primary Tumor
|
11.1 percentage of participants
Interval 0.0 to 25.6
|
5.0 percentage of participants
Interval 0.0 to 14.6
|
SECONDARY outcome
Timeframe: Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks); Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks)Population: Tumor regression grade (primary tumor)
The regression of the primary tumor was quantified according to the 5-point tumor regression grade proposed by Dworak. Complete regression = No tumor cells ; Near complete regression = Very few tumor cells; Moderate regression = Dominantly fibrotic changes with few tumor cells or groups; Minimal regression = Dominant tumor mass with obvious fibrosis
Outcome measures
| Measure |
Induction XELOX-RT (Arm A)
n=18 Participants
induction XELOX followed by XELOX-RT (arm A)
|
XELOX-RT Alone (Arm B)
n=20 Participants
no induction XELOX, XELOX-RT alone (arm B)
|
|---|---|---|
|
Tumor Regression Grade (Primary Tumor)
Surgery not performed
|
2 Participants
|
1 Participants
|
|
Tumor Regression Grade (Primary Tumor)
Total regression
|
2 Participants
|
1 Participants
|
|
Tumor Regression Grade (Primary Tumor)
Near total regression
|
2 Participants
|
4 Participants
|
|
Tumor Regression Grade (Primary Tumor)
Moderate regression
|
10 Participants
|
11 Participants
|
|
Tumor Regression Grade (Primary Tumor)
Minimal regression
|
2 Participants
|
3 Participants
|
Adverse Events
During Induction XELOX (Arm A)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
During Preoperative Chemoradiotherapy With XELOX (Arm A)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 1 deaths
During Preoperative Chemoradiotherapy With XELOX (Arm B)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
During Postoperative XELOX (Arm A)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
During Posoperative XELOX (Arm B)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
During Induction XELOX (Arm A)
n=18 participants at risk
consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 2 cycles.
|
During Preoperative Chemoradiotherapy With XELOX (Arm A)
n=15 participants at risk
consisted of radiation therapy with 45 Gy delivered in conventional fractionation (daily fractions of 1.8 Gy over a period of approximately 5 wk, excluding weekends) with or without additional 5.4 Gy delivery in daily fractions of 1.8 Gy over 3 days, oxaliplatin 50 mg/m2 weekly for 5 weeks, and capecitabine 825 mg/m2 twice daily on days 1 to 38 (during radiation therapy)
|
During Preoperative Chemoradiotherapy With XELOX (Arm B)
n=20 participants at risk
consisted of radiation therapy with 45 Gy delivered in conventional fractionation (daily fractions of 1.8 Gy over a period of approximately 5 wk, excluding weekends) with or without additional 5.4 Gy delivery in daily fractions of 1.8 Gy over 3 days, oxaliplatin 50 mg/m2 weekly for 5 weeks, and capecitabine 825 mg/m2 twice daily on days 1 to 38 (during radiation therapy)
|
During Postoperative XELOX (Arm A)
n=14 participants at risk
Surgery was planned with total mesorectal excision and simultaneous liver metastasectomy with or without addition of radiofrequency ablation within 6 weeks after completion of preoperative treatments. Postoperative chemotherapy (postoperative CapeOx) consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 6 cycles.
|
During Posoperative XELOX (Arm B)
n=17 participants at risk
Surgery was planned with total mesorectal excision and simultaneous liver metastasectomy with or without addition of radiofrequency ablation within 6 weeks after completion of preoperative treatments. Postoperative chemotherapy (postoperative CapeOx) consisted of oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1 to 14, every 3 weeks for 6 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
22.2%
4/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
6.7%
1/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
10.0%
2/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
50.0%
7/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
52.9%
9/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
4/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
20.0%
3/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
10.0%
2/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
64.3%
9/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
58.8%
10/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
3/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
33.3%
5/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
20.0%
4/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
50.0%
7/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
5.9%
1/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
13.3%
2/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
5.0%
1/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
General disorders
Fatigue
|
27.8%
5/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
33.3%
5/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
45.0%
9/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
14.3%
2/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
29.4%
5/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
20.0%
3/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
35.0%
7/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
28.6%
4/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
52.9%
9/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
46.7%
7/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
40.0%
8/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
0.00%
0/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
17.6%
3/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Nervous system disorders
Sensory neuropathy
|
50.0%
9/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
33.3%
5/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
65.0%
13/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
100.0%
14/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
82.4%
14/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
Nervous system disorders
Hand foot syndrome
|
0.00%
0/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
6.7%
1/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
5.0%
1/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
21.4%
3/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
23.5%
4/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
|
General disorders
Anal pain
|
5.6%
1/18 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
26.7%
4/15 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
40.0%
8/20 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
7.1%
1/14 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
17.6%
3/17 • Arm A = Induction chemotherapy (XELOX, 6 weeks) followed by chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks). Arm B = Chemoradiotherapy (XELOX plus radiotherapy) to surgery (6 weeks), followed by postoperative chemotherapy (XELOX, 18 weeks).
Adverse events were analyzed by treatment exposure. This included Induction Chemotherapy (only Arm A), Preoperative Chemoradiotherapy, and Postoperative Chemotherapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place