Trial Outcomes & Findings for Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer (NCT NCT00033657)

Last Updated: 2023-06-28

Results Overview

A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Results posted on

2023-06-28

Participant Flow

E1201 opened to accrual on May 21, 2002 and accrued its first patient on August 15, 2002. A total of 97 patients were accrued from 19 different participating sites.

Participant milestones

Participant milestones
Measure	Cisplatin / Irinotecan / RT (Arm A) Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Neoadjuvant Chemotherapy STARTED	50	47
Neoadjuvant Chemotherapy Eligible	42	43
Neoadjuvant Chemotherapy Eligible and Treated	39	42
Neoadjuvant Chemotherapy COMPLETED	36	36
Neoadjuvant Chemotherapy NOT COMPLETED	14	11
Surgical Resection STARTED	36	36
Surgical Resection COMPLETED	36	33
Surgical Resection NOT COMPLETED	0	3
Adjuvant Chemotherapy STARTED	36	33
Adjuvant Chemotherapy COMPLETED	18	16
Adjuvant Chemotherapy NOT COMPLETED	18	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Cisplatin / Irinotecan / RT (Arm A) Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Neoadjuvant Chemotherapy Lack of Efficacy	1	2
Neoadjuvant Chemotherapy Adverse Event	0	2
Neoadjuvant Chemotherapy Death	1	1
Neoadjuvant Chemotherapy Withdrawal by Subject	1	0
Neoadjuvant Chemotherapy other complicating disease	0	1
Neoadjuvant Chemotherapy Ineligible	8	4
Neoadjuvant Chemotherapy Not started protocol therapy	3	1
Surgical Resection not complete resection	0	3
Adjuvant Chemotherapy Lack of Efficacy	3	1
Adjuvant Chemotherapy Adverse Event	7	10
Adjuvant Chemotherapy Death	2	1
Adjuvant Chemotherapy Withdrawal by Subject	5	3
Adjuvant Chemotherapy alternative therapy	1	0
Adjuvant Chemotherapy Other	0	2

Baseline Characteristics

Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin / Irinotecan / RT (Arm A) n=39 Participants Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) n=42 Participants Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.	Total n=81 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	59.9 years STANDARD_DEVIATION 10.7 • n=7 Participants	58.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	42 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Population: Eligible, treated patients

A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.

Outcome measures

Outcome measures
Measure	Cisplatin / Irinotecan / RT (Arm A) n=39 Participants Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) n=42 Participants Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Pathologic Complete Response Rate	15.4 percentage of participants Interval 6.9 to 28.1	16.7 percentage of participants Interval 8.1 to 29.0

SECONDARY outcome

Timeframe: Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Population: Eligible, treated patients

Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.

Outcome measures

Outcome measures
Measure	Cisplatin / Irinotecan / RT (Arm A) n=39 Participants Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) n=42 Participants Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Overall Survival Time	35.0 Months Interval 19.5 to 67.7	21.0 Months Interval 17.4 to 49.3

SECONDARY outcome

Timeframe: Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry

Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.

Outcome measures

Outcome measures
Measure	Cisplatin / Irinotecan / RT (Arm A) n=39 Participants Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Paclitaxel / Cisplatin / RT (Arm B) n=42 Participants Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.
Recurrence-free Survival Time	39.8 Months Interval 13.3 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	12.4 Months Interval 11.0 to 31.4

Adverse Events

Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)

Serious events: 32 serious events

Other events: 47 other events

Deaths: 0 deaths

Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)

Serious events: 30 serious events

Other events: 46 other events

Deaths: 0 deaths

Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)

Serious events: 20 serious events

Other events: 30 other events

Deaths: 0 deaths

Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)

Serious events: 15 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

Eastern Cooperative Oncology Group (ECOG) Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) n=47 participants at risk Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) n=46 participants at risk Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.	Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) n=31 participants at risk Adjuvant chemotherapy toxicities in treated patients	Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) n=27 participants at risk
Investigations Leukopenia	36.2% 17/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	34.8% 16/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	48.4% 15/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	22.2% 6/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Lymphopenia	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Neutropenia	31.9% 15/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	28.3% 13/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	51.6% 16/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	29.6% 8/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Thrombocytopenia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Blood and lymphatic system disorders Transfusion:PRBCS	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Cardiac disorders Sinus bradycardia	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Vascular disorders Hypertension	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Vascular disorders Hypotension	4.3% 2/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Blood and lymphatic system disorders Thrombosis/Embolism	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
General disorders Fatigue	4.3% 2/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	10.9% 5/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
General disorders Fever	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Weight loss	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Anorexia	19.1% 9/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	16.1% 5/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Constipation	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Dehydration	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	14.8% 4/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Dysphagia	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Dysphagia-esophageal radiation	12.8% 6/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	17.4% 8/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Mucositis due to radiation	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Nausea	23.4% 11/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	13.0% 6/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Vomiting	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	14.8% 4/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Diarrhea w/o prior colostomy	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	16.1% 5/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Bilirubin increased	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Hepatobiliary disorders AST increased	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Hepatobiliary disorders ALT increased	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Blood and lymphatic system disorders Febrile neutropenia	4.3% 2/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Infections and infestations Infection w/o neutropenia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hyperglycemia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypokalemia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypomagnesemia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hyponatremia	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypophosphatemia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Dizziness/lightheadedness	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Neuropathy-motor	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Syncope	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Tremor	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Cardiac disorders Chest pain	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Neuropathic pain	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Pain due to radiation	4.3% 2/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	2.2% 1/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy

Other adverse events
Measure	Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A) n=47 participants at risk Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles	Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B) n=46 participants at risk Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy. Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles.	Adjuvant_Cisplatin / Irinotecan / RT ( Arm A) n=31 participants at risk Adjuvant chemotherapy toxicities in treated patients	Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B) n=27 participants at risk
Blood and lymphatic system disorders Anemia	80.9% 38/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	87.0% 40/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	90.3% 28/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	81.5% 22/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Leukopenia	93.6% 44/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	89.1% 41/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	87.1% 27/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	63.0% 17/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Neutropenia	74.5% 35/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	52.2% 24/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	74.2% 23/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	33.3% 9/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Thrombocytopenia	66.0% 31/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	63.0% 29/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	67.7% 21/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	29.6% 8/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
General disorders Edema	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
General disorders Fatigue	68.1% 32/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	71.7% 33/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	74.2% 23/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	70.4% 19/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Weight loss	40.4% 19/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	37.0% 17/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	48.4% 15/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	37.0% 10/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Skin and subcutaneous tissue disorders Alopecia	25.5% 12/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	28.3% 13/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	32.3% 10/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	51.9% 14/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Radiation dermatitis	17.0% 8/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	13.0% 6/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Skin and subcutaneous tissue disorders Rash/desquamation	0.00% 0/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Anorexia	44.7% 21/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	39.1% 18/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	35.5% 11/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	51.9% 14/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Constipation	21.3% 10/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	26.1% 12/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Dehydration	12.8% 6/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	26.1% 12/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	12.9% 4/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Dyspepsia	14.9% 7/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Dysphagia	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Dysphagia-esophageal radiation	38.3% 18/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	45.7% 21/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Injury, poisoning and procedural complications Dysphagia-pharyngeal radiation	14.9% 7/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Mouth dryness	6.4% 3/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 3/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Nausea	55.3% 26/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	65.2% 30/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	61.3% 19/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	51.9% 14/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Stomatitis	6.4% 3/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	17.4% 8/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Taste disturbance	19.1% 9/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	32.6% 15/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	25.8% 8/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	37.0% 10/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Vomiting	42.6% 20/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	34.8% 16/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	32.3% 10/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	33.3% 9/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Diarrhea w/o prior colostomy	36.2% 17/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	34.8% 16/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	45.2% 14/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	48.1% 13/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Alkaline phosphatase increased	21.3% 10/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	15.2% 7/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	32.3% 10/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	25.9% 7/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Investigations Bilirubin increased	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	13.0% 6/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypoalbuminemia	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Hepatobiliary disorders AST increased	10.6% 5/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	19.6% 9/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Hepatobiliary disorders ALT increased	36.2% 17/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	37.0% 17/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	16.1% 5/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	22.2% 6/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hyperglycemia	14.9% 7/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	19.6% 9/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypocalcemia	12.8% 6/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	13.0% 6/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypokalemia	10.6% 5/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hypomagnesemia	6.4% 3/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	15.2% 7/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	12.9% 4/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Metabolism and nutrition disorders Hyponatremia	4.3% 2/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	19.6% 9/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Dizziness/lightheadedness	10.6% 5/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	23.9% 11/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Psychiatric disorders Insomnia	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	4.3% 2/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Psychiatric disorders Anxiety/agitation	6.4% 3/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.2% 1/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	11.1% 3/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Nervous system disorders Neuropathy-sensory	8.5% 4/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	15.2% 7/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	9.7% 3/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	44.4% 12/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Gastrointestinal disorders Abonominal pain	17.0% 8/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	15.2% 7/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	16.1% 5/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	25.9% 7/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 3/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	0.00% 0/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	7.4% 2/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy
Respiratory, thoracic and mediastinal disorders Dyspnea	10.6% 5/47 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	8.7% 4/46 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	6.5% 2/31 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy	3.7% 1/27 • Reported 4-6 weeks after the end of pre-op chemotherapy/RT, (just prior to resection) and 4 weeks after the end of adjuvant chemotherapy