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Table 1 Study calendar. Pre-Study Testing Intervals. To be completed ≤21 DAYS before registration: All laboratory studies, history and physical. To be completed ≤28 DAYS before registration: CT/MRI scans used for staging

From: Alliance for clinical trials in oncology (ALLIANCE) trial A021501: preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas

 

Prior to Pre-Reg

Prior to Reg*

Day 1 of each cycle of mFOLFIR-INOX*

RT (day 1 to day 5) (Arm 2 only)

Surgery

Day 1 of each cycle of FOLFOX *

Post Tx Follow- up**

Tests & Observations

History and physical, weight, PS ***

 

X [1]

X [1]

X [1]

 

X [1]

X [1]

Pulse, BP

 

X [1]

X [1]

X [1]

 

X [1]

X [1]

Height

 

X [1]

     

Adverse Event Assessment (CTCAE) †

 

X [1]

X [1]

X [1]

D [1]

X [1]

 

Adverse Event Assessment (PRO-CTCAE) ††

 

X [2]

X

X

D

X

 

Registration QOL/Mental Well-being/Physical Well-being/Fatigue

 

X [2]

     

Laboratory Studies

CBC, Differential, Platelets

 

X

X

X

X

X

X

Chemistry (Serum Creatinine, Electrolytes, AST, ALT, Alk. Phos., Albumin, Total Bilirubin)

 

X

X

X

X

X

X

Pregnancy Test (#)

 

X

     

CA 19–9

 

A

A

A

A

A

X

RT Planning

EUS with Fiducial Placement for RT

   

B

   

Staging

Staging CT Scan of Chest or Chest X-ray/CT or MRI of Abdomen

X [3]

 

C [3]

C [3]

C [3]

C [3]

X [3]

Central Radiographic Review

 

C

  

C

  

Central Pathology Review

    

X [4]

  

Optional Correlative studies: For patients who consent to participate

Blood specimen sample (A021501-PP1)

Between Registration and C1D1. See Additional file 1: Section 6.2.

Imaging (A021501-IM1)

See Additional file 1: Section 6.4.2 for CT images submission time points and requirements.

  1. *Labs completed prior to registration may be used for day 1 of cycle 1 if obtained ≤7 days prior to treatment (except pregnancy test and CA 19–9, as detailed below). For subsequent cycles, labs, tests and observations may be obtained +/− 3 days from scheduled day of assessment. Radiographic windows are +/− 7 days from scheduled day of assessment
  2. **After off-treatment (evaluation of the last treatment cycle), patients will have physical examinations, labs, and staging scans every 16 weeks (+/− 28 days) until they have reached 24 months post-registration or until documented progression, whichever occurs first. Thereafter, survival information is required every 6 months for 5 years post-registration. For patients who discontinue treatment for progressive disease or are removed from protocol treatment, survival information is required every 6 months for 5 years post-registration. See Additional file 1: Section 12.0 for removal of patients from protocol therapy
  3. ***Drug dosages need not be changed unless the calculated dose changes by ≥10%
  4. 1 May be performed by physician, NP, or PA responsible for oncologic care of the patient
  5. 2 To be completed after registration and ≤21 days prior to treatment. See Additional file 1: Appendix I
  6. 3 Chest scans must be CT or chest X-ray. Abdominal baseline and restaging scans can include either a CT or MRI, although CT is preferred. The same method of scanning used at baseline must be used for all subsequent evaluations. The CT must be acquired with 3 mm or less slice thickness. See Additional file 1: Section 7.4.1 for further details. Supporting documentation is to be submitted, per Additional file 1: Section 6.1.1. The baseline scan and restaging scan after completion of preoperative therapy/prior to surgery are to be centrally reviewed by the Alliance ICL at IROC Ohio, per Additional file 1: Section 7.4.2
  7. 4 Central Pathology review is retrospective. Sites must submit slides within 60 days of surgery of patient. See Additional file 1: Section 6.2
  8. †Solicited AEs are to be collected starting at baseline. Routine AEs are to be collected starting after registration. See Additional file 1: Section 9.1 for the list of solicited AEs. See Additional file 1: Section 9.4 for expedited reporting of SAEs. See Additional file 1: Section 9.2 for reporting of surgical AEs, to be completed within 90 days after surgery
  9. ††Patients complete PRO-CTCAE by paper booklet ordered through the CTSU website. See Additional file 1: Section 9.1 for administration instructions. See Additional file 1: Appendix I for PRO-CTCAE assessments for IRB submission and review only. See Additional file 1: Section 4.5 for ordering instructions. PRO-CTCAE booklets should be administered at the following time points: ≤ 21 days prior to treatment; day 1 of each cycle of mFOLFIRINOX (+/− 3 days); RT days 1–5 (Arm 2 only); prior to surgery (+/− 7 days); and day 1 of each cycle of FOLFOX (+/− 3 days)
  10. # For women of childbearing potential (see Additional file 1: Section 3.3.6). Must be done ≤7 days prior to registration
  11. A CA19–9 may be performed <28 days prior to registration. Subsequently, CA 19–9 may be performed +/− 14 days from the scheduled date. During treatment, CA 19–9 should be performed every 28 days. For patients who have normal CA 19–9 levels at baseline, continued testing of CA 19–9 is not required
  12. B EUS/fiducial marker placement is mandatory for patients in the RT arm. Immediately following review of first restaging studies, planning for EUS/fiducial placement and RT simulation should be scheduled to be performed during either cycle 5 or 6 of mFOLFIRINOX
  13. C Restaging scans should be performed for both Arm 1 and Arm 2 at the following time points: 1. After the first 4 cycles of mFOLFIRINOX; 2. Prior to Surgery; 3. Post-surgery but prior to first cycle of FOLFOX; 4. After 4 cycles while on FOLFOX. The baseline and restaging scan after completion of preoperative therapy and prior to surgery are to be centrally reviewed by the Alliance ICL at IROC Ohio per Additional file 1: Section 7.4.2. After protocol treatment, scans should be performed per the schedule indicated by footnote “**”
  14. D Surgery-related AEs should be assessed and captured within 90 days of surgery
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BMC Cancer

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