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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00613080
First received: February 9, 2008
Last updated: June 11, 2013
Last verified: June 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine
Drug: oxaliplatin
Procedure: resection
Radiation: radiation therapy
Drug: FOLFOX

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
STARTED     79  
COMPLETED     68 [1]
NOT COMPLETED     11  
Ineligible / no protocol treatment                 11  
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients.

Reporting Groups
  Description
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)

Baseline Measures
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
Number of Participants  
[units: participants]
  68  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 29 to 77 )  
Gender  
[units: participants]
 
Female     30  
Male     38  



  Outcome Measures

1.  Primary:   The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively   [ Time Frame: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery) ]

2.  Secondary:   Intensity-modulated Radiotherapy (IMRT) Feasibility   [ Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pathologic Complete Response Rate   [ Time Frame: After protocol surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   All Treatment-related Adverse Events Per NCI CTCAE v3.0 Preoperative, Postoperative, and Overall   [ Time Frame: Three timeframes: Start of treatment to surgery, Surgery to 3 months after the completion of postoperative chemotherapy and Combined ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Patterns of Failure (i.e., Local, Regional, and Distant), Including Overall Survival (Death Due to Any Cause)   [ Time Frame: From registration to date of local failure, regional failure, distant failure, death or last follow-up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Rate of Anterior Posterior Resections   [ Time Frame: From registration to end of follow-up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
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)

Other Adverse Events
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
Total, other (not including serious) adverse events    
# participants affected / at risk     67/68  
Blood and lymphatic system disorders    
Anemia * 1  
# participants affected / at risk     41/68 (60.29%)  
Blood and lymphatic system disorders - Other * 1  
# participants affected / at risk     4/68 (5.88%)  
Hemolysis * 1  
# participants affected / at risk     1/68 (1.47%)  
Cardiac disorders    
Atrial flutter * 1  
# participants affected / at risk     1/68 (1.47%)  
Palpitations * 1  
# participants affected / at risk     1/68 (1.47%)  
Paroxysmal atrial tachycardia * 1  
# participants affected / at risk     1/68 (1.47%)  
Sinus tachycardia * 1  
# participants affected / at risk     3/68 (4.41%)  
Supraventricular tachycardia * 1  
# participants affected / at risk     1/68 (1.47%)  
Endocrine disorders    
Endocrine disorders - Other * 1  
# participants affected / at risk     1/68 (1.47%)  
Hyperthyroidism * 1  
# participants affected / at risk     1/68 (1.47%)  
Eye disorders    
Blurred vision * 1  
# participants affected / at risk     4/68 (5.88%)  
Dry eye * 1  
# participants affected / at risk     1/68 (1.47%)  
Extraocular muscle paresis * 1  
# participants affected / at risk     1/68 (1.47%)  
Eye disorders - Other * 1  
# participants affected / at risk     2/68 (2.94%)  
Watering eyes * 1  
# participants affected / at risk     3/68 (4.41%)  
Gastrointestinal disorders    
Abdominal distension * 1  
# participants affected / at risk     5/68 (7.35%)  
Abdominal pain * 1  
# participants affected / at risk     24/68 (35.29%)  
Anal fistula * 1  
# participants affected / at risk     1/68 (1.47%)  
Anal mucositis * 1  
# participants affected / at risk     1/68 (1.47%)  
Anal pain * 1  
# participants affected / at risk     10/68 (14.71%)  
Anal stenosis * 1  
# participants affected / at risk     1/68 (1.47%)  
Colitis * 1  
# participants affected / at risk     2/68 (2.94%)  
Colonic obstruction * 1  
# participants affected / at risk     1/68 (1.47%)  
Constipation * 1  
# participants affected / at risk     28/68 (41.18%)  
Diarrhea * 1  
# participants affected / at risk     52/68 (76.47%)  
Dyspepsia * 1  
# participants affected / at risk     9/68 (13.24%)  
Dysphagia * 1  
# participants affected / at risk     7/68 (10.29%)  
Enterocolitis * 1  
# participants affected / at risk     2/68 (2.94%)  
Esophageal hemorrhage * 1  
# participants affected / at risk     1/68 (1.47%)  
Fecal incontinence * 1  
# participants affected / at risk     5/68 (7.35%)  
Flatulence * 1  
# participants affected / at risk     3/68 (4.41%)  
Gastrointestinal disorders - Other * 1  
# participants affected / at risk     10/68 (14.71%)  
Gingival pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Hemorrhoidal hemorrhage * 1  
# participants affected / at risk     1/68 (1.47%)  
Hemorrhoids * 1  
# participants affected / at risk     1/68 (1.47%)  
Ileal fistula * 1  
# participants affected / at risk     1/68 (1.47%)  
Malabsorption * 1  
# participants affected / at risk     1/68 (1.47%)  
Mucositis oral * 1  
# participants affected / at risk     11/68 (16.18%)  
Nausea * 1  
# participants affected / at risk     49/68 (72.06%)  
Oral pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Proctitis * 1  
# participants affected / at risk     7/68 (10.29%)  
Rectal fistula * 1  
# participants affected / at risk     4/68 (5.88%)  
Rectal hemorrhage * 1  
# participants affected / at risk     9/68 (13.24%)  
Rectal pain * 1  
# participants affected / at risk     26/68 (38.24%)  
Rectal stenosis * 1  
# participants affected / at risk     2/68 (2.94%)  
Small intestinal obstruction * 1  
# participants affected / at risk     3/68 (4.41%)  
Upper gastrointestinal hemorrhage * 1  
# participants affected / at risk     1/68 (1.47%)  
Vomiting * 1  
# participants affected / at risk     27/68 (39.71%)  
General disorders    
Chills * 1  
# participants affected / at risk     5/68 (7.35%)  
Edema limbs * 1  
# participants affected / at risk     5/68 (7.35%)  
Fatigue * 1  
# participants affected / at risk     53/68 (77.94%)  
Fever * 1  
# participants affected / at risk     9/68 (13.24%)  
Flu like symptoms * 1  
# participants affected / at risk     1/68 (1.47%)  
General disorders and administration site conditions - Other * 1  
# participants affected / at risk     1/68 (1.47%)  
Non-cardiac chest pain * 1  
# participants affected / at risk     6/68 (8.82%)  
Pain * 1  
# participants affected / at risk     11/68 (16.18%)  
Immune system disorders    
Allergic reaction * 1  
# participants affected / at risk     5/68 (7.35%)  
Infections and infestations    
Catheter related infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Esophageal infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Infections and infestations - Other * 1  
# participants affected / at risk     9/68 (13.24%)  
Pelvic infection * 1  
# participants affected / at risk     2/68 (2.94%)  
Peripheral nerve infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Scrotal infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Sinusitis * 1  
# participants affected / at risk     1/68 (1.47%)  
Skin infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Stoma site infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Urinary tract infection * 1  
# participants affected / at risk     2/68 (2.94%)  
Vaginal infection * 1  
# participants affected / at risk     3/68 (4.41%)  
Wound infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Injury, poisoning and procedural complications    
Bruising * 1  
# participants affected / at risk     1/68 (1.47%)  
Burn * 1  
# participants affected / at risk     1/68 (1.47%)  
Dermatitis radiation * 1  
# participants affected / at risk     13/68 (19.12%)  
Fracture * 1  
# participants affected / at risk     1/68 (1.47%)  
Gastrointestinal anastomotic leak * 1  
# participants affected / at risk     1/68 (1.47%)  
Injury, poisoning and procedural complications - Other * 1  
# participants affected / at risk     1/68 (1.47%)  
Intraoperative gastrointestinal injury * 1  
# participants affected / at risk     1/68 (1.47%)  
Radiation recall reaction (dermatologic) * 1  
# participants affected / at risk     11/68 (16.18%)  
Rectal anastomotic leak * 1  
# participants affected / at risk     1/68 (1.47%)  
Vascular access complication * 1  
# participants affected / at risk     2/68 (2.94%)  
Wound dehiscence * 1  
# participants affected / at risk     4/68 (5.88%)  
Investigations    
Activated partial thromboplastin time prolonged * 1  
# participants affected / at risk     2/68 (2.94%)  
Alanine aminotransferase increased * 1  
# participants affected / at risk     24/68 (35.29%)  
Alkaline phosphatase increased * 1  
# participants affected / at risk     16/68 (23.53%)  
Aspartate aminotransferase increased * 1  
# participants affected / at risk     23/68 (33.82%)  
Blood bilirubin increased * 1  
# participants affected / at risk     11/68 (16.18%)  
CD4 lymphocytes decreased * 1  
# participants affected / at risk     1/68 (1.47%)  
Cholesterol high * 1  
# participants affected / at risk     1/68 (1.47%)  
Creatinine increased * 1  
# participants affected / at risk     5/68 (7.35%)  
GGT increased * 1  
# participants affected / at risk     2/68 (2.94%)  
INR increased * 1  
# participants affected / at risk     1/68 (1.47%)  
Investigations - Other * 1  
# participants affected / at risk     6/68 (8.82%)  
Lymphocyte count decreased * 1  
# participants affected / at risk     21/68 (30.88%)  
Neutrophil count decreased * 1  
# participants affected / at risk     33/68 (48.53%)  
Platelet count decreased * 1  
# participants affected / at risk     34/68 (50.00%)  
Serum amylase increased * 1  
# participants affected / at risk     1/68 (1.47%)  
Weight loss * 1  
# participants affected / at risk     17/68 (25.00%)  
White blood cell decreased * 1  
# participants affected / at risk     41/68 (60.29%)  
Metabolism and nutrition disorders    
Acidosis * 1  
# participants affected / at risk     1/68 (1.47%)  
Anorexia * 1  
# participants affected / at risk     25/68 (36.76%)  
Dehydration * 1  
# participants affected / at risk     18/68 (26.47%)  
Glucose intolerance * 1  
# participants affected / at risk     1/68 (1.47%)  
Hypercalcemia * 1  
# participants affected / at risk     1/68 (1.47%)  
Hyperglycemia * 1  
# participants affected / at risk     35/68 (51.47%)  
Hyperkalemia * 1  
# participants affected / at risk     7/68 (10.29%)  
Hypermagnesemia * 1  
# participants affected / at risk     3/68 (4.41%)  
Hypernatremia * 1  
# participants affected / at risk     1/68 (1.47%)  
Hypertriglyceridemia * 1  
# participants affected / at risk     1/68 (1.47%)  
Hyperuricemia * 1  
# participants affected / at risk     1/68 (1.47%)  
Hypoalbuminemia * 1  
# participants affected / at risk     16/68 (23.53%)  
Hypocalcemia * 1  
# participants affected / at risk     19/68 (27.94%)  
Hypokalemia * 1  
# participants affected / at risk     17/68 (25.00%)  
Hypomagnesemia * 1  
# participants affected / at risk     7/68 (10.29%)  
Hyponatremia * 1  
# participants affected / at risk     18/68 (26.47%)  
Hypophosphatemia * 1  
# participants affected / at risk     2/68 (2.94%)  
Musculoskeletal and connective tissue disorders    
Arthralgia * 1  
# participants affected / at risk     4/68 (5.88%)  
Arthritis * 1  
# participants affected / at risk     1/68 (1.47%)  
Back pain * 1  
# participants affected / at risk     5/68 (7.35%)  
Bone pain * 1  
# participants affected / at risk     5/68 (7.35%)  
Buttock pain * 1  
# participants affected / at risk     2/68 (2.94%)  
Generalized muscle weakness * 1  
# participants affected / at risk     4/68 (5.88%)  
Muscle weakness left-sided * 1  
# participants affected / at risk     1/68 (1.47%)  
Muscle weakness lower limb * 1  
# participants affected / at risk     1/68 (1.47%)  
Muscle weakness upper limb * 1  
# participants affected / at risk     1/68 (1.47%)  
Musculoskeletal and connective tissue disorder - Other * 1  
# participants affected / at risk     1/68 (1.47%)  
Myalgia * 1  
# participants affected / at risk     3/68 (4.41%)  
Neck pain * 1  
# participants affected / at risk     2/68 (2.94%)  
Osteoporosis * 1  
# participants affected / at risk     1/68 (1.47%)  
Pain in extremity * 1  
# participants affected / at risk     5/68 (7.35%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Tumor pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Nervous system disorders    
Ataxia * 1  
# participants affected / at risk     1/68 (1.47%)  
Depressed level of consciousness * 1  
# participants affected / at risk     1/68 (1.47%)  
Dizziness * 1  
# participants affected / at risk     5/68 (7.35%)  
Dysgeusia * 1  
# participants affected / at risk     15/68 (22.06%)  
Dysphasia * 1  
# participants affected / at risk     1/68 (1.47%)  
Headache * 1  
# participants affected / at risk     12/68 (17.65%)  
Ischemia cerebrovascular * 1  
# participants affected / at risk     1/68 (1.47%)  
Memory impairment * 1  
# participants affected / at risk     2/68 (2.94%)  
Nervous system disorders - Other * 1  
# participants affected / at risk     5/68 (7.35%)  
Peripheral motor neuropathy * 1  
# participants affected / at risk     8/68 (11.76%)  
Peripheral sensory neuropathy * 1  
# participants affected / at risk     49/68 (72.06%)  
Sinus pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Syncope * 1  
# participants affected / at risk     1/68 (1.47%)  
Tremor * 1  
# participants affected / at risk     1/68 (1.47%)  
Psychiatric disorders    
Agitation * 1  
# participants affected / at risk     4/68 (5.88%)  
Anxiety * 1  
# participants affected / at risk     7/68 (10.29%)  
Confusion * 1  
# participants affected / at risk     1/68 (1.47%)  
Depression * 1  
# participants affected / at risk     6/68 (8.82%)  
Insomnia * 1  
# participants affected / at risk     21/68 (30.88%)  
Libido decreased * 1  
# participants affected / at risk     1/68 (1.47%)  
Personality change * 1  
# participants affected / at risk     2/68 (2.94%)  
Renal and urinary disorders    
Acute kidney injury * 1  
# participants affected / at risk     2/68 (2.94%)  
Cystitis noninfective * 1  
# participants affected / at risk     5/68 (7.35%)  
Hematuria * 1  
# participants affected / at risk     1/68 (1.47%)  
Proteinuria * 1  
# participants affected / at risk     1/68 (1.47%)  
Renal and urinary disorders - Other * 1  
# participants affected / at risk     3/68 (4.41%)  
Urinary frequency * 1  
# participants affected / at risk     12/68 (17.65%)  
Urinary incontinence * 1  
# participants affected / at risk     4/68 (5.88%)  
Urinary retention * 1  
# participants affected / at risk     3/68 (4.41%)  
Urinary tract pain * 1  
# participants affected / at risk     5/68 (7.35%)  
Reproductive system and breast disorders    
Ejaculation disorder * 1  
# participants affected / at risk     1/68 (1.47%)  
Pelvic pain * 1  
# participants affected / at risk     2/68 (2.94%)  
Perineal pain * 1  
# participants affected / at risk     3/68 (4.41%)  
Prostatic pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Testicular pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Vaginal discharge * 1  
# participants affected / at risk     1/68 (1.47%)  
Vaginal dryness * 1  
# participants affected / at risk     1/68 (1.47%)  
Vaginal obstruction * 1  
# participants affected / at risk     2/68 (2.94%)  
Respiratory, thoracic and mediastinal disorders    
Atelectasis * 1  
# participants affected / at risk     1/68 (1.47%)  
Cough * 1  
# participants affected / at risk     11/68 (16.18%)  
Dyspnea * 1  
# participants affected / at risk     10/68 (14.71%)  
Epistaxis * 1  
# participants affected / at risk     6/68 (8.82%)  
Hiccups * 1  
# participants affected / at risk     2/68 (2.94%)  
Hypoxia * 1  
# participants affected / at risk     1/68 (1.47%)  
Pharyngeal mucositis * 1  
# participants affected / at risk     1/68 (1.47%)  
Pharyngolaryngeal pain * 1  
# participants affected / at risk     3/68 (4.41%)  
Pleural effusion * 1  
# participants affected / at risk     2/68 (2.94%)  
Pleuritic pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Pneumonitis * 1  
# participants affected / at risk     2/68 (2.94%)  
Respiratory, thoracic and mediastinal disorders - Other * 1  
# participants affected / at risk     2/68 (2.94%)  
Skin and subcutaneous tissue disorders    
Alopecia * 1  
# participants affected / at risk     12/68 (17.65%)  
Body odor * 1  
# participants affected / at risk     1/68 (1.47%)  
Dry skin * 1  
# participants affected / at risk     8/68 (11.76%)  
Erythema multiforme * 1  
# participants affected / at risk     1/68 (1.47%)  
Hyperhidrosis * 1  
# participants affected / at risk     5/68 (7.35%)  
Pain of skin * 1  
# participants affected / at risk     2/68 (2.94%)  
Palmar-plantar erythrodysesthesia syndrome * 1  
# participants affected / at risk     11/68 (16.18%)  
Pruritus * 1  
# participants affected / at risk     3/68 (4.41%)  
Rash maculo-papular * 1  
# participants affected / at risk     9/68 (13.24%)  
Skin and subcutaneous tissue disorders - Other * 1  
# participants affected / at risk     5/68 (7.35%)  
Skin hyperpigmentation * 1  
# participants affected / at risk     1/68 (1.47%)  
Skin ulceration * 1  
# participants affected / at risk     2/68 (2.94%)  
Vascular disorders    
Flushing * 1  
# participants affected / at risk     3/68 (4.41%)  
Hot flashes * 1  
# participants affected / at risk     4/68 (5.88%)  
Hypertension * 1  
# participants affected / at risk     2/68 (2.94%)  
Hypotension * 1  
# participants affected / at risk     4/68 (5.88%)  
Thromboembolic event * 1  
# participants affected / at risk     5/68 (7.35%)  
Vascular disorders - Other * 1  
# participants affected / at risk     1/68 (1.47%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, CTCAE (4.0)



  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information