Registration and randomization

Give instructions for registering or randomizing patients and list and define any stratification variables and the questions that need to be answered before a patient can be entered; these relate to eligibility checking and factors required for stratification.

EORTC : 80931 MRC : B006

Form 1

EOI TRIAL OF CHEMOTHERAPY +/- G-CSF IN OPERABLE OSTEOSARCOMA REGISTRATION/ON-STUDY FORM

Please complete this form before randomising the patient and send top copy to your data coordinating centre.

Patient's name/ID code:

Responsible Clinician: .

Institution: Hospital number:

(where chemotherapy will be given)

Pathologist:

Initial biopsy hospital: (initial biopsy)

Surgeon:

(definitive surgery)

Pathology ref. no:. (initial specimen)

2 = Female

ELIGIBILITY Please confirm the following by ticking the box

1. Biopsy proven osteosarcoma of long bones of an extremity

2. Untreated non-metastatic disease Age ^ 40 years

Chemotherapy planned to start within 4 weeks of biopsy

Neutrophils >1.5x107I (or WBC »3.5 x 10»/l if neutrophils not available) and platelet count > 100 x 107I Glomerular Filtration Rate ^60 ml/min 1.73 m2 Serum bilirubin «20 nmol/l

8. No history of cardiac malfunction

9. Informed consent should be obtained according to local regulations

Thoracic scan

IU/L Alkaline phosphatase

IU/L LDH

_ Location on bone

3 = Distal

Intended surgical procedure at randomisation

1 = Amputation

2 = Disarticulation

3 = Rotation plasty

4 = Limb salvage

RANDOMISATION

Allocated treatment

□ 1 = Regimen 1 (CDDP + DOX) 2 = Regimen 2 (CDDP + DOX + G-i

CSF)

Date of randomisation

EORTC/MRC patient number

Signed Date

Fig. 7.6 Registration/on-study form from an osteosarcoma trial.

EORTC : 80931 MRC : B006

Form 2

EOI TRIAL OF CHEMOTHERAPY +/• G-CSF IN OPERABLE OSTEOSARCOMA CHEMOTHERAPY FORM

Please complete this form at the end of each cycle of chemotherapy and send top copy to your data coordinating centre.

Patient's name/ID code: Institution:

EORTC/MRC patient number

1 Cycle number m2 Surface area cm Height Kg Weight

Date of start of cycle (D,M,Y)

mg CDDP Dose this cycle

□ Major reason for delay/reduction

1 = No delay/reduction

2 = Administrative

3 = Haematological toxicity

4 = Renal toxicity

5 = Ototoxicity

6 = Neurotoxicity

7 = Infection

mg DOX Total dose this cycle

Major reason for delay/reduction

1 = No delay/reduction

2 = Administrative

3 = Haematological toxicity

4 = Renal toxicity

5 = Ototoxicity

6 = Neurotoxicity

7 = Infection

FOR G-CSF REGIMEN ONLY

10 |ig G-CSF Total dose this cycle

Was any toxicity attributed to G-CSF

Laboratory values

Date of test (D,M,Y) WBCx 107L Neutrophils x 109/L Platelets x 109/L Renal clearance ml/min/1.73m2 Alkaline phosphatase IU/L LDH IU/L Calcium mmol/l Magnesium mmol/l LFT

Before start of cycle

Electrolytes

Normal Abnormal

Side effects of treatment (Please use toxicity coding on back of book and specify grade) Nausea/Vomiting Oral

Infection

Other, specify

Neurological

Ototoxicity

Cardiac

Signed Date.

Fig. 7.7 Chemotherapy form from an osteosarcoma trial.

Signed Date .

Fig. 7.8 Follow-up form from an osteosarcoma trial.

Signed Date .

Fig. 7.8 Follow-up form from an osteosarcoma trial.

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