untitled h1
12.2 appendix ii late rtog

| ORGAN TISSUE                                           | 0                                                                                            | Grade 1                                                                         | Grade 2                          | Grade 3   | Grade 4   |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------|-----------|-----------|
| Slight atrophy Pigmentation  change Some hair loss     | Patch atrophy; Moderate  telangiectasia; Total hair  loss                                    | Marked atrophy; Gross  telangiectasia                                           | Ulceration                       |           |           |
| SKIN                                                   | None                                                                                         | Slight                                                                          | Moderate fibrosis but            |           |           |
| induration                                             | asymptomatic                                                                                 |                                                                                 |                                  |           |           |
| (fibrosia) and                                         | Slight field contracture                                                                     |                                                                                 |                                  |           |           |
| loss of                                                | <10% linear reduction                                                                        |                                                                                 |                                  |           |           |
| subcutaneous fat                                       | Severe induration and loss of  subcutaneous tissue Field contracture >10% linear measurement |                                                                                 |                                  |           |           |
| SUBCUTANEOUS  TISSUE                                   | None                                                                                         | Necrosis                                                                        |                                  |           |           |
| Moderate atrophy and  telangiectasia Little mucous     | Marked atrophy with complete  dryness Severe telangiectasia                                  |                                                                                 |                                  |           |           |
| MUCOUS  MEMBRANE                                       | None                                                                                         | Slight atrophy  and dryness                                                     | Ulceration                       |           |           |
| Slight dryness  of mouth Good response  on stimulation | Moderate dryness of  mouth Poor response on  stimulation                                     |                                                                                 |                                  |           |           |
| SALIVARY  GLANDS                                       | None                                                                                         | Complete dryness of mouth                                                       | Fibrosis                         |           |           |
| No response on stimulation                             |                                                                                              |                                                                                 |                                  |           |           |
| Mild  L'Hermitte's  syndrome                           | Severe L'Hermitte's  syndrome                                                                | Objective neurological findings  at or below cord level treated                 | Mono, para  quadraplegia         |           |           |
| SPINAL CORD                                            | None                                                                                         | Severe headaches Severe CNS dysfunction  (partial loss of power or  dyskinesia) | Seizures or  paralysis Coma      |           |           |
| BRAIN                                                  | None                                                                                         | Mild headache Slight lethargy                                                   | Moderate headache Great lethargy |           |           |  
| ORGAN TISSUE                                                           | 0                                                                                | Grade 1                                                                                                      | Grade 2                                                                                                                                                                                 | Grade 3                                                                                                                   | Grade 4                                                               |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Asymptomatic  cataract Minor corneal  ulceration or  keratitis         | Symptomatic cataract Moderate corneal  ulceration Minor retinopathy or  glaucoma | Severe keratitis Severe retinopathy or  detachment Severe glaucoma                                           | Panopthalmitis/  Blindness                                                                                                                                                              |                                                                                                                           |                                                                       |
| EYE                                                                    | None                                                                             | Hoarseness Slight arytenoid  edema                                                                           | Moderate arytenoid  edema Chondritis                                                                                                                                                    | Severe edema Severe chondritis                                                                                            | Necrosis                                                              |
| LARYNX                                                                 | None                                                                             | Asymptomatic  or mild  symptoms (dry  cough) Slight  radiographic  appearances                               | Moderate symptomatic  fibrosis or pneumonitis  (severe cough) Low grade fever Patchy radiographic  appearances                                                                          | Severe  respiratory  insufficiency/  Continuous O2/  Assisted  ventilation                                                |                                                                       |
| Severe symptomatic fibrosis or  pneumonitis Dense radiographic changes |                                                                                  |                                                                                                              |                                                                                                                                                                                         |                                                                                                                           |                                                                       |
| LUNG                                                                   | None                                                                             | Asymptomatic  or mild  symptoms Transient T  wave inversion  & ST changes Sinus  tachycardia  >110 (at rest) | Moderate angina on  effort Mild pericarditis Normal heart size Persistent abnormal T  wave and ST changes Low ORS                                                                       | Severe angina Pericardial effusion Constrictive pericarditis Moderate heart failure Cardiac enlargement EKG abnormalities | Tamponade/  Severe heart  failure/ Severe  constrictive  pericarditis |
| HEART                                                                  | None                                                                             | Mild fibrosis Slight difficulty  in swallowing  solids No pain on  swallowing                                | Unable to take solid food  normally Swallowing semi-solid  food Dilatation may be  indicated Severe fibrosis Able to swallow only liquids May have pain on swallowing Dilation required | Necrosis/  Perforation Fistula                                                                                            |                                                                       |
| ESOPHAGUS                                                              | None                                                                             |                                                                                                              |                                                                                                                                                                                         |                                                                                                                           |                                                                       |  
| ORGAN TISSUE                                                                                     | 0                                                                                                            | Grade 1                                                                                                                                       | Grade 2                                                                                                                                                        | Grade 3                                                                                                                                          | Grade 4                                          |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Mild diarrhea Mild cramping Bowel  movement 5  times daily Slight rectal  discharge or  bleeding | Moderate diarrhea and  colic Bowel movement >5  times daily Excessive rectal mucus  or intermittent bleeding | Necrosis/  Perforation Fistula                                                                                                                |                                                                                                                                                                |                                                                                                                                                  |                                                  |
| SMALL/LARGE  INTESTINE                                                                           | None                                                                                                         | Obstruction or bleeding requiring surgery                                                                                                     |                                                                                                                                                                |                                                                                                                                                  |                                                  |
| Mild lassitude Nausea,  dyspepsia Slightly  abnormal liver  function                             | Disabling hepatitic  insufficiency Liver function tests grossly  abnormal Low albumin Edema or ascites       |                                                                                                                                               |                                                                                                                                                                |                                                                                                                                                  |                                                  |
| Moderate symptoms Some abnormal liver  function tests Serum albumin normal                       | Necrosis/  Hepatic coma  or  encephalopathy                                                                  |                                                                                                                                               |                                                                                                                                                                |                                                                                                                                                  |                                                  |
| LIVER                                                                                            | None                                                                                                         | Transient  albuminuria No hypertension Mild  impairment of  renal function Urea 25-35  mg% Creatinine 1.5- 2.0 mg% Creatinine  clearance >75% | Persistent moderate  albuminuria (2+) Mild hypertension No related anemia Moderate impairment of  renal function Urea>36-60 mg% Creatinine clearance (50- 74%) | Severe albuminuria Severe hypertension Persistent anemia (<10g%) Severe renal failure Urea >60 mg% Creatinine >4.0 mg% Creatinine clearance <50% | Malignant  hypertension Uremic  coma/Urea  >100% |
| KIDNEY                                                                                           | None                                                                                                         |                                                                                                                                               |                                                                                                                                                                |                                                                                                                                                  |                                                  |  
| ORGAN TISSUE                                                                                                                                        | 0                                                                                  | Grade 1                                                                                  | Grade 2                                                                  | Grade 3                                                                       | Grade 4 Necrosis/  Contracted  bladder  (capacity <100  cc) Severe  hemorrhagic  cystitis   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Severe frequency and dysuria Severe generalized  telangiectasia (often with  petechiae) Frequent hematuria Reduction in bladder capacity  (<150 cc) |                                                                                    |                                                                                          |                                                                          |                                                                               |                                                                                             |
| Slight epithelial  atrophy Minor  telangiectasia  (microscopic  hematuria)                                                                          | Moderate frequency Generalized  telangiectasia Intermittent macroscopic  hematuria |                                                                                          |                                                                          |                                                                               |                                                                                             |
| BLADDER                                                                                                                                             | None                                                                               | Asymptomatic No growth  retardation Reduced bone  density                                | Moderate pain or  tenderness Growth retardation Irregular bone sclerosis | Severe pain or tenderness Complete arrest of bone growth Dense bone sclerosis | Necrosis/  Spontaneous  fracture                                                            |
| BONE                                                                                                                                                | None                                                                               | Moderate stiffness Intermittent or moderate  joint pain Moderate limitation of  movement |                                                                          |                                                                               |                                                                                             |
| Mild joint  stiffness Slight limitation  of movement                                                                                                | Severe joint stiffness Pain with severe limitation of  movement                    | Necrosis/  Complete  fixation                                                            |                                                                          |                                                                               |                                                                                             |
| JOINT                                                                                                                                               | None                                                                               |                                                                                          |                                                                          |                                                                               |                                                                                             |  
GUIDELINES: The late morbidity criteria are used to score/grade toxicity from radiation therapy. The critera are relevant from day 90 after completion of therapy. The evaluator must attempt to discriminate between disease- and treatment-related signs and symptoms.  
All toxicities Grade 3, 4 or 5* must be verified by the Principal Investigator. *ANY TOXICITY WHICH CAUSED DEATH IS GRADED 5.  
12.3 APPENDIX III. EXCLUDED IMMUNOSUPRESSIVE MEDICATIONS Adalimumab (HUMIRA) Azathioprine Basiliximab (Simulect) Certolizumab pegol (Cimzia) Cyclophosphamide Cyclosporin Daclizumab (Zenapax) Dactinomycin Etanercept (Enbrel) Golimumab (Simponi) Ifliximab (Remicade) Methotrexate Mercaptopurine Muromonab-CD3 Mycophenolate Rituxan Sirolimus Tacrolimus Oral or intravenously delivered glucocorticoids