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Table 2 Study calendar. pre-study testing to be completed ≤ 28 DAYS before registration: scan of any type which is used for tumor measurement per protocol, all laboratory studies and history and physical

From: Alliance for clinical trials in Oncology (Alliance) trial A022101/NRG-GI009: a pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur)

 

Prior to Pre-Registration

Day 1 of each cycle of systemic therapy*

Prior to Registration/Randomization*

During Total Ablative Therapy (TAT) **

During Standard of Care Treatment (SOC) **

Follow-up***

Tests & Observations

  

History & Physical, weight, performance status

 

X

X

X

X

X

Height

  

X

   

Pulse, Blood Pressure

 

X

X

X

X

 

CTCAE Adverse Event Assessment

 

X(1)

X(1)

X(1)

X(1)

X(1)

Laboratory Studies

  

CBC including Differential

 

X

X

X

X

X

Comprehensive Metabolic Panel

 

X(2)

X(2)

X(2)

X(2)

X(2)

Serum or Urine HCG

  

X(3)

   

CEA

  

X(4)

  

X(4)

CD4 count

  

X(5)

   

Staging

  

CT chest, CT (or MRI) abdomen/pelvis (or PET/CT)

A

B

B

B

B

B

  1. * Labs completed prior to registration may be used for Day 1 of Cycle 1 of the next planned cycle of systemic therapy (if registration occurs prior to initiation of systemic therapy) if obtained ≤ 14 days prior to treatment. For subsequent cycles, labs, scans, tests, and observations may be obtained ≤ 3 business days prior to day of treatment
  2. ** For patients on Arm 1, physical examination, vitals, adverse event (AE) assessment, and labs are required at 14–18 weeks post-randomization. For patients on Arm 2, physical examination, vitals, AE assessment and labs are required at least prior to the start of each cycle for patients receiving active systemic therapy and 14–18 weeks post-randomization. For patients on a treatment break, physical examination, vitals, AE assessment and labs are required at 14–18 weeks post-randomization
  3. *** Following the first assessment timepoint at 14–18 weeks post-randomization, patients should undergo physical examination, AE assessment, labs, and staging scans every 3 months (+/- 1 month) until disease progression or start of off-protocol anticancer therapy, whichever comes first. Off-protocol anticancer therapy incudes any experimental agent, a systemic therapy regimen not specifically included outlined in the protocol, or, for patients randomized to Arm 2 (institutional SOC therapy), local metastatic-directed therapy other than what is delivered for palliation. Patients who discontinue study treatment due to disease progression (or who start a new anticancer therapy after discontinuing study treatment for reasons other than disease progression) should be followed every 6 months for survival until 5 years after registration
  4. 1 Solicited adverse events are to be collected starting prior to treatment until off-treatment. Routine adverse events are to be collected starting after registration until the end of survival follow-up. For patients who register before/during systemic therapy, the first routine adverse event assessment should take place after registration but prior to Day 1 of the next planned cycle of systemic therapy
  5. 2 Albumin, alkaline phosphatase, total bilirubin, bicarbonate (or total CO2), BUN, chloride, creatinine, glucose, potassium, total protein, SGOT (AST), SGPT (ALT), and sodium
  6. 3 For women of childbearing potential. Must be done ≤ 14 days prior to registration
  7. 4 Perform at baseline (prior to initiation of systemic therapy, if applicable), ≤ 28 days prior to registration, ≤ 28 days prior to randomization, 14–18 weeks post-randomization, then every 3 months (+/- 1 month) for the first three years after randomization, then every 6 months (+/- 1 month) for years 4–5 after registration. Any measurements of biochemical response should occur in conjunction with the radiologic assessments for disease status
  8. 5 To be performed ≤ 28 days prior to registration only for patients with known HIV positivity
  9. A Baseline scans should include CT chest and CT or MRI of the abdomen/pelvis. The CT component of a PET-CT is also acceptable if the CT is of diagnostic quality (using oral and IV contrast if possible). CT scans should be of diagnostic quality and performed with oral and IV contrast unless there is a medical contraindication. MRIs should be performed with IV contrast unless there is a medical contraindication. For patients who register after initiation of induction systemic therapy, baseline imaging obtained ≤ 28 days prior to initiation of systemic therapy must be available. For patients with liver disease, triple-phase CT or MRI with IV contrast can be obtained for treatment planning as directed by the treating physician
  10. B Response assessment should include assessment of all sites of disease and the same imaging method used at baseline must be used for all subsequent scans. The first response assessment imaging time point is 14–18 weeks post-randomization. Imaging should then be obtained every 3 months (+/- 1 month) until evidence of progression or relapse
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BMC Cancer

ISSN: 1471-2407

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