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Table 1 Schematic diagrams for the schedule

From: Reduction of cycles of neoadjuvant chemotherapy for advanced epithelial ovarian, fallopian or primary peritoneal cancer (ROCOCO): study protocol for a phase III randomized controlled trial

 

Screening

1st cycle

2nd cycle

3rd cycle

IDS

4th cycle

5th cycle

6th cycle

Follow-up

(1) Control group

 Informed consent

O

        

 Review of the inclusion and exclusion criteria

O

        

 WHO performance status & physical examination

O

O

O

O

O

O

O

O

 

 Tumour markers1

O

O2

O2

O2

O3

O2

O2

O4

O5

 BRCA test

â–³6

        

 Tumour measurements (CT, PET-CT)

O7

  

O7

O8

  

O8

O9

 Adverse events

 

O

O

O

 

O

O

O

 

 Postoperative complications

    

O

    

 Quality of life

O10

   

O11

  

O11

O12

 

Screening

1st cycle

2nd cycle

IDS

3rd cycle

4th cycle

5th cycle

6th cycle

Follow-up

(2) Experimental group

 Informed consent

O

        

 Review of the inclusion and exclusion criteria

O

        

 WHO performance status & physical examination

O

O

O

O

O

O

O

O

 

 Tumour markers1

O

O2

O2

O3

O2

O2

O2

O4

O5

 BRCA test

â–³6

        

 Tumour measurements (CT, PET-CT)

O7

 

O7

O8

   

O8

O9

 Adverse events

 

O

O

 

O

O

O

O

 

 Postoperative complications

   

O

     

 Quality of life

O10

  

O11

   

O11

O12

  1. 1Cancer antigen-125 (CA-125), carcinoembryonic antigen (CEA), human epididymis protein-4 (HE-4), premenopausal Risk of Ovarian Malignancy Algorithm (ROMA), postmenopausal ROMA
  2. 2Performed within one week before the onset of chemotherapy
  3. 3Performed within one week before interval debulking surgery (IDS)
  4. 4Peformed within one week before the onset of the sixth cycle of chemotherapy and three weeks its completion. If total number of chemotherapy cycles is seven or more, tumour markers are evaluated three weeks after the completion of the last cycle of chemotherapy
  5. 5Performed every three months for the first two years and then every six months for the last three years
  6. 6Performed selectively after informed consent (one additional cancer panel using tumour tissues can be performed after informed consent if there is disease recurrence or progression)
  7. 7Peformed at the screening time and after the completion of neoadjuvant chemotherapy
  8. 8Only CT is performed three weeks after IDS (within six weeks), and three weeks after the completion of the 6th cycle of chemotherapy. If total number of chemotherapy cycles is seven or more, CT is performed three weeks after the completion of the last cycle of chemotherapy
  9. 9Only CT is performed every three months for the first two years and then every six months for the last three years
  10. 10EORTC QLQ-C30, EORTC QLQ-Ov28, FACT-O, EQ-5D-5 L are administered to evaluate quality of life
  11. 11EORTC QLQ-C30, EORTC QLQ-Ov28, FACT-O, EQ-5D-5 L, CTSQ are administered after IDS and three weeks after the completion of the sixth cycle of chemotherapy
  12. 12EORTC QLQ-C30, EORTC QLQ-Ov28, FACT-O, EQ-5D-5 L are administered six months after the completion of the sixth cycle of chemotherapy