Trial Outcomes & Findings for Non-Operative Management and Early Response Assessment in Rectal Cancer (NCT NCT03904043)

Last Updated: 2025-10-23

Results Overview

\- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

63 participants

Primary outcome timeframe

Completion of treatment (estimated to be 22 weeks)

Results posted on

2025-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation + FOLFOX * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
Overall Study STARTED	55	8
Overall Study COMPLETED	51	7
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation + FOLFOX * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Non-compliance	1	0
Overall Study Did not start treatment	1	0

Baseline Characteristics

Non-Operative Management and Early Response Assessment in Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation + FOLFOX n=55 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX n=8 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Total n=63 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	60 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	2 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	6 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	8 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	7 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	8 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Completion of treatment (estimated to be 22 weeks)

Outcome measures

Outcome measures
Measure	Radiation + FOLFOX n=51 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX n=7 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
Clinical Complete Response Rate	36 Participants	2 Participants

SECONDARY outcome

Timeframe: At 2 years

* Criteria for progressive disease: * Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm) * New metastatic disease * PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment through the completion of treatment (estimated to be 22 weeks)

\- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Outcome measures

Outcome measures
Measure	Radiation + FOLFOX n=54 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX n=8 Participants * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
Incidence of Any Grade 3 or Higher Toxicity During Treatment Abdominal pain	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Acidosis	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Anal pain	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Anemia	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Anorexia	0 Participants	2 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Aspartate aminotransferase increased	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Congestive heart failure	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Dehydration	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Delirium	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Depression	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Fatigue	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Febrile neutropenia	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Generalized muscle weakness	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hyperglycemia	3 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hypoalbuminemia	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hypocalcemia	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hypokalemia	2 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hyponatremia	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Infection - cellulitis	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Platelet count decreased	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Proctitis	2 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Rectal hemorrhage	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Superior vena cava syndrome	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Thromboembolic event	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Vomiting	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment White blood cell decreased	7 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Alanine aminotransferase increased	2 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Anxiety	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Diarrhea	5 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Fall	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Hypertension	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Neutrophil count decreased	22 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Peripheral sensory neuropathy	1 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Rectal pain	0 Participants	1 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Skin infection	1 Participants	0 Participants
Incidence of Any Grade 3 or Higher Toxicity During Treatment Weight loss	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At 1 year after the start of radiation

\- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10-14 months after radiation therapy

* Questionnaire with 5 sections (physical well-being, social/family well being, emotional well-being, functional well-being, and additional concerns) * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 years

Outcome measures

Outcome data not reported

Adverse Events

Radiation + FOLFOX

Serious events: 21 serious events

Other events: 28 other events

Deaths: 1 deaths

Radiation + CAPOX

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Michael Waters

Washington University School of Medicine

Phone: 314-747-7236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Radiation + FOLFOX n=54 participants at risk * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks). * Oxaliplatin day 1 every 14 days * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available. * 5-FU bolus day 1 every 14 days * 5-FU infusion day 1 every 14 days over 46 hours * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted	Radiation + CAPOX n=8 participants at risk * Pelvic radiotherapy 5GY x 5 fractions once daily * Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily * CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks). * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle * An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
Blood and lymphatic system disorders Anemia	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Cardiac disorders Congestive heart failure	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Gastrointestinal disorders Anal pain	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Gastrointestinal disorders Diarrhea	7.4% 4/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Gastrointestinal disorders Proctitis	3.7% 2/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
General disorders Fatigue	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Infections and infestations Cellulitis	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Alanine aminotransferase increased	3.7% 2/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Aspartate aminotransferase increased	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Lymphocyte count decreased	9.3% 5/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Neutrophil count decreased	31.5% 17/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Platelet count decreased	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations Weight loss	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Investigations White blood cell decreased	11.1% 6/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Metabolism and nutrition disorders Anorexia	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	25.0% 2/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Metabolism and nutrition disorders Hyperglycemia	3.7% 2/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Metabolism and nutrition disorders Hypokalemia	3.7% 2/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Nervous system disorders Peripheral sensory neuropathy	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Psychiatric disorders Anxiety	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Psychiatric disorders Delirium	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Psychiatric disorders Depression	0.00% 0/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	12.5% 1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
Vascular disorders Hypertension	1.9% 1/54 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.	0.00% 0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation). Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.