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Table 3 CABOCOL-01 study procedures

From: CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure

 

Before inclusion

within 28 days before drug initiation

During treatment (1 cycle = 28 days)

End of treatment

30 days after the last dose of study treatment

(+/−  7 days)

Follow-up every 3 months up to progression

Overall survival after disease progression

Cycle 1

Cycle 2

Other Cycles from cycle 2

Additional Assessment at D1C4 and every 3 cycles (D1C7, D1C10 …)

(within 7 days)

D1

D15

D1

D15

D1

Study drug administration

 

CABOZANTINIB treatment (in a 28 day-cycle)

 

Informed Consent

should be done before any study procedures

        

No study visit is required. The following treatment is at the discretion of physician

Clinical assessment

- Complete physical examination including gynecological examination, weight, height (only at baseline), ECOG, vital signs

- Adverse Events collection and concomitant treatments

 

Laboratory Assessments1

- Blood assessment

- Urinary assessment

within 14 days before drug initiation

3

within 3 days

within 3 days

within 3 days

within 3 days

 

within 3 days

within 3 days

Cardiac assessment

- ECG (QT interval)

- Cardiac Echography or MUGA

  

  

  

Quality-of-life assessment

EORTC QLQ-C30 / CX24

   

 

  

Diary card

 

4

 

 

   

Radiological assessment

- CT-scan (thorax, abdominal and pelvis) 6

- Pelvic MRI 2

   

within 3 days

 

+/− 7 days

 

+/− 14 days

Biological collections

- Tumoral biopsy optional5

- Blood samples

  

 

at progression

  1. 1Laboratory assessment
  2. • Hematology (CBC, platelets)
  3. • Serum biochemistry (Albumin, total alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), corrected calcium, creatinine and clearance by CKD-EPI method, glutamyltransferase (GGT), glucose, lactate deshydrogenase (LDH), magnesium, phosphorus, potassium, sodium, total bilirubin (conjugated and unconjugated if clinically indicated), total protein
  4. • Coagulation (PT/INR and PTT) mandatory before inclusion, then for other visits only if clinically indicated
  5. • Thyroid function tests (TSH, free T3, free T4) (at each biological assessment except D15C1 and D15C2)
  6. • Tumor marker: SCC antigen (at each biological assessment except D15C1)
  7. • Urine analysis:
  8. - Before inclusion: Urine analysis: urine protein-to-creatinine ratio (UPCR) ≤ 1 g/g (≤ 113.2 mg/mmol) creatinine or 24-h urine protein < 1 g. When a UPCR exceeds 1 g/g, a repeat UPCR or a 24-h urine protein and creatinine should be performed to confirm the result
  9. -For other visits: Urine dipstick (with protein, blood and leucokytes).
  10. If results > 2+, an urinary analysis must be performed with a Urine protein / creatinine ratio (UPCR). When a UPCR exceeds 1 g/g, a repeat UPCR or a 24-h urine protein and creatinine should be performed to confirm the result.
  11. • Urinal pregnancy test (Women of childbearing potential), only before inclusion
  12. 2Mandatory pelvis IRM at inclusion and optional for further evaluations. MRI can be used in addition of CT scan if a local recurrence could not be assessed by CT
  13. 3Only if realized more 14 days before D1
  14. 4Subjects should be instructed before the beginning of the treatment of the risk of diarrhea and the initial management. A preventive prescription can be given to the patient at the beginning of the treatment.
  15. 5Fresh biopsy from primitive and/or from metastatic sites if feasible and only if the patient agrees on the consent form. AND Mandatory: One paraffin block of archival initial or recurrent tumour will be sent to sponsor during study.
  16. 6A central review of the scanners will be done in the study to assess sarcopenia. An anonymized copy of the scanner imagery will be sent to the sponsor during the study