Trial Outcomes & Findings for Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer (NCT NCT00613080)

Last Updated: 2018-09-25

Results Overview

The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events \<= 90 days from the start of concurrent treatment are included.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Results posted on

2018-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Study STARTED	79
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Study Ineligible / no protocol treatment	11

Baseline Characteristics

Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)

Population: Eligible subjects who started study treatment.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively	51 percentage of patients Interval to 59.0 This is a one-sided confidence interval.

SECONDARY outcome

Timeframe: Pretreatment

Population: Eligible patients who started study treatment

Real-time quality assurance was performed remotely by the study chair or the radiation oncology co-chair prior to initiation of treatment for the first 40 cases. The final cases enrolled were reviewed within 3 months after accrual was completed. Review included evaluation of clinical target volume (CTV) and planning target volume (PTV), Organs at Risk (OARs), and treatment plan dosimetry.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Contouring score · Per Protocol	58 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Contouring score · Acceptable variation	5 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Contouring score · Unacceptable variation	5 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Contouring score · Per Protocol	62 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Contouring score · Acceptable variation	6 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Contouring score · Unacceptable variation	0 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Dose volume analysis score · Per Protocol	59 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Dose volume analysis score · Acceptable variation	8 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Tumor volume: Dose volume analysis score · Unacceptable variation	1 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Dose volume analysis score · Per Protocol	48 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Dose volume analysis score · Acceptable variation	17 Participants
Number of Patients in Protocol Adherence Categories for Intensity-modulated Radiotherapy (IMRT) Planning Organs at risk: Dose volume analysis score · Unacceptable variation	3 Participants

SECONDARY outcome

Timeframe: At the time of surgery, which is 4-8 weeks after radiation therapy, approximately 9-13 weeks from treatment start.

Population: Eligible patients who started study treatment

Pathologic complete response is defined as no evidence of residual cancer histologically in the resection specimen.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Number of Patients With Pathologic Complete Response	10 Participants

SECONDARY outcome

Timeframe: From study registration to end of follow-up. Maximum follow-up at time of analysis was 5.2 years.

Population: For the four time periods reported, respectively: all registered patients; patients that had surgery; patients that had surgery and postoperative chemotherapy; all registered patients.

Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Adverse events were compiled in four different time periods: 1) Preoperative: Preoperatively or, if no surgery, then ≤ 90 days from the Start of Concurrent Treatment; 2) Postoperative#1: Postoperatively and ≤ 30 days from the Date of Surgery; 3) Postoperative#2: Postoperatively and ≤ 90 days from the End of Postoperative Chemotherapy; 4) Overall: From start of concurrent treatment to end of follow-up;

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Preoperative	49 percentage of participants Interval 37.0 to 60.0
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Postoperative #1	7 percentage of participants Interval 3.0 to 17.0
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Postoperative #2	74 percentage of participants Interval 59.0 to 85.0
Percentage of Patients With Grade 3 or Higher Treatment-related Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Overall	78 percentage of participants Interval 67.0 to 86.0

SECONDARY outcome

Timeframe: From registration to four years

Population: Eligible patients who started study treatment

Local failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) reported at surgery or reported after the end of protocol treatment; or (2) persistence \[failure at one day post study entry\], absence of CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Regional failure is defined as: (1) any recurrence after a nodal CR reported at surgery or reported after the end of protocol treatment; or (2) persistence, absence of nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Local-regional failure time is defined as time from registration to local or regional failure, last known follow-up (censored), or death (competing risk). Local-regional failure rates are estimated by the cumulative incidence method.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Local-regional Failure: 4-year Rate	7.4 percentage of participants Interval 1.0 to 13.7

SECONDARY outcome

Timeframe: From registration to four years

Population: Eligible patients who started study treatment

Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Time to distant failure is defined as time from registration to the date of distant failure, last known follow-up (censored), or death (competing risk). Distant failure rates are estimated by the cumulative incidence method.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Distant Failure: 4-year Rate	29.7 percentage of participants Interval 18.7 to 40.8

SECONDARY outcome

Timeframe: From registration to four years

Population: Eligible patients who started study treatment

Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Overall Survival: 4-year Rate	82.9 percentage of participants Interval 70.1 to 90.6

SECONDARY outcome

Timeframe: From registration to four years

Population: Eligible patients who started study treatment

Disease is defined as local-regional failure or distant failure. Distant failure is defined as the appearance of peritoneal seeding or distant metastases. Local-regional failure is defined as: (1) any recurrence or surgery to the primary site after a complete response (CR) / any recurrence after a nodal CR - reported at surgery or reported after the end of protocol treatment; or (2) persistence \[failure at one day post study entry\], absence of primary/nodal CR after protocol treatment was completed and patient lived at least 90 days from the end of treatment. Disease-free survival time is defined as time from registration to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Disease-free Survival: 4-year Rate	60.6 percentage of participants Interval 47.5 to 71.4

SECONDARY outcome

Timeframe: Surgery occurred 4 to 8 weeks following the completion of radiation therapy, approximately 9-13 weeks from start of treatment.

Population: Eligible patients that had surgery

All patients were to undergo surgery 4 to 8 weeks following the completion of radiation therapy. The choice of procedure (abdominoperineal resection (APR), low anterior resection (LAR), or LAR/coloanal anastomosis) was at the discretion of the surgeon. If more than 28 patients received abdominoperineal resection, this would result in a conclusion of an excessive number of abdominoperineal resections.

Outcome measures

Outcome measures
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=67 Participants Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Number of Patients Who Underwent Abdominoperineal Resection	14 Participants

Adverse Events

IMRT + Chemotherapy , Resection, Postoperative Chemotherapy

Serious events: 23 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 participants at risk Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Blood and lymphatic system disorders Hemoglobin decreased	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial tachycardia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Myocardial ischemia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus tachycardia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Colonic stenosis	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Enteritis	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophageal hemorrhage	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal disorder	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Ileus	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis oral	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	4.4% 3/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal hemorrhage	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal pain	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Small intestinal obstruction	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	4.4% 3/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	4.4% 3/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fever	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Peritoneal infection	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Pneumonia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Sepsis	4.4% 3/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Intraoperative complications	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Rectal anastomotic leak	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Wound dehiscence	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alkaline phosphatase increased	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Creatinine increased	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypermagnesemia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	2.9% 2/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypomagnesemia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Ischemia cerebrovascular	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal failure	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Ureteric obstruction	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Reproductive system and breast disorders Pelvic pain	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Rash desquamating	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Sweating	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypertension	1.5% 1/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Other adverse events
Measure	IMRT + Chemotherapy , Resection, Postoperative Chemotherapy n=68 participants at risk Radiation therapy (intensity modulated radiation therapy \[IMRT\] + three dimensional conformal radiation therapy \[3D-CRT\]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
Blood and lymphatic system disorders Blood disorder	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin decreased	58.8% 40/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Vision blurred	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal distension	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	36.8% 25/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Anal pain	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	45.6% 31/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	80.9% 55/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	13.2% 9/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	10.3% 7/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Fecal incontinence	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Flatulence	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal disorder	16.2% 11/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Mucositis oral	17.6% 12/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	70.6% 48/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Proctitis	10.3% 7/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal fistula	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal hemorrhage	13.2% 9/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Rectal pain	39.7% 27/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	36.8% 25/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chest pain	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chills	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema limbs	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	79.4% 54/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fever	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	17.6% 12/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Immune system disorders Hypersensitivity	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation	19.1% 13/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	17.6% 12/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Vascular access complication	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Wound dehiscence	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alanine aminotransferase increased	35.3% 24/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Alkaline phosphatase increased	25.0% 17/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Aspartate aminotransferase increased	33.8% 23/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Creatinine increased	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Hyperbilirubinemia	16.2% 11/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Laboratory test abnormal	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Leukopenia	60.3% 41/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	33.8% 23/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	50.0% 34/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	50.0% 34/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight loss	26.5% 18/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	39.7% 27/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	26.5% 18/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	51.5% 35/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperkalemia	10.3% 7/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	23.5% 16/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	29.4% 20/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	25.0% 17/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypomagnesemia	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	26.5% 18/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Bone pain	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Joint pain	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Neck pain	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	19.1% 13/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neurological disorder NOS	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral motor neuropathy	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	73.5% 50/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Taste alteration	22.1% 15/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Agitation	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	13.2% 9/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	32.4% 22/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Cystitis	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary frequency	19.1% 13/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Urinary incontinence	5.9% 4/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	17.6% 12/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.2% 11/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	20.6% 14/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dry skin	11.8% 8/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	17.6% 12/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Rash desquamating	14.7% 10/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin disorder	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Sweating	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hot flashes	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypotension	7.4% 5/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thrombosis	8.8% 6/68 Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place