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Table 2 SIRveNIB trial assessment schedule

From: Single administration of Selective Internal Radiation Therapy versus continuous treatment with sorafeNIB in locally advanced hepatocellular carcinoma (SIRveNIB): study protocol for a phase iii randomized controlled trial

Schedule

Screening/Baseline (Eligibility) Randomisationa

During Protocol Therapy

Study Conclusion

Post Study Conclusion Follow-Up

Week 2b

Week 4

Week 8

Week 12

12-weekly thereafter

As appropriatec

12 weekly

Informed consent

X

       

Demographics

X

       

Medical and surgical history

X

       

Concurrent illness

X

       

Concomitant medications

Xd

Xd

Xd

Xd

Xd

Xd

Xd

 

Clinical assessment & physical examination

• Height (Baseline only)

• Weight

• Blood pressure

• Body temperature

X

 

X

X

X

X

X

 

Performance status

• ECOG

X

 

X

X

X

X

X

 

Haematology

• Leukocytes

• Platelets

• Haemoglobin

• INR

X

 

X

X

X

X

X

 

Hepatitis serology

• Hep Bsag

• Anti-HCV IgG

• Hep B Core Antibody IgG (optional)

Xe

       

Renal function

• Creatinine

X

 

X

X

X

X

X

 

Liver function

• AST/ALT

• ALP

• Total bilirubin

• Albumin

X

 

X

X

X

X

X

 

Pregnancy test (as appropriate)

Xf

       

Tumour marker

• Serum AFP

X

   

X

X

X

 

EQ-5D HRQoL

X

 

X

X

X

X

X

X

CT or MRI scan: chest/abdomen/pelvish, i

X

   

X

X

  

SIRT-arm ONLY

• Hepatic angiogram

• 99mTc- MAA lung shunt study

X g

       

Response assessment

    

X

X

X

 

Sorafenib arm ONLY

• Toxicity assessment

• Dose delay/modification

 

Xb

X

X

X

X

X

 

AE/SAE

AE/SAE for the Sorafenib arm will be recorded from the time of signing the ICF until 30 days after the final dose of Sorafenib, or until commencement of the next alternative therapy, whichever is earlier.

AE/SAE for the SIRT arm will be recorded from the time of signing the ICF until 30 days post-SIRT regardless of causality and for a further 5 months thereafter if judged by the investigator to be causally related to SIRT or Sir-Spheres, or until commencement of the next alternative therapy, whichever is earlier.

If the AE/SAE is a Sorafenib or SIRT related toxicity follow-up will continue until resolution.

Survival

 

X

  1. aScreening assessments performed within 28 days before signing of informed consent can be used to confirm eligibility
  2. bSorafenib arm only. Sorafenib patients contacted at Week 2 to assess treatment related toxicity and interrupt/modify the dose as necessary
  3. cDisease progression, death, complete regression, unacceptable toxicity, patient responds to treatment and becomes eligible for surgical resection, liver transplantation or ablative therapy, lost to follow-up, patient’s request for withdrawal
  4. dConcomitant medication to be recorded from screening up to 30 days post-study conclusion, or until commencement of the next alternative therapy, whichever is earlier
  5. eIf either the Hepatitis B Surface Antigen (Hep Bsag) test or anti-HCV IgG test is positive, the other test will be optional. Hepatitis B Core Antibody IgG test is optional
  6. fWomen of reproductive potential must have a negative pregnancy test before commencing treatment. Test to be repeated if pregnancy is suspected during the study
  7. gHepatic angiogram and 99mTc-MAA lung shunt study to be performed after randomisation and prior to treatment commencement only for SIRT arm group
  8. hThe same radiological assessment method must be used throughout the study
  9. i Assessment for tumour response rate to be done every 12 weeks from date of randomisation until first evidence of disease progression
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BMC Cancer

ISSN: 1471-2407

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