High-dose Intensity-modulated proton therapy versus Standard-dose Intensity-modulated RadIation therapy for esophageal squamous cell carcinoma (HI-SIRI): study protocol for a randomized controlled clinical trial

Table 1 Patient assessment schedule

Diagnostic study	Pre-study^a	Prior to CCRT	Weekly during CCRT	Prior to each CMT cycle	12 weeks after CCRT	Follow-up visits^g
History and physical exam	x	x	x	x	x	x
Nutritional evaluation	x	x	x	x	x	x
Complete blood count	x^b	x	x	x	x	x
Liver and renal function	x^b	x		x
Tumor markers	x					x
Bronchoscopy^c	x
EGD with biopsy	x				x^f	x^f
CT chest	x^d				x	x
PET/CT scan^e	x				x	x
Endoscopic ultrasound^e	x				x^f	x^f
Bone scan^e	x					x
Toxicity evaluation			x	x	x	x
QOL questionnaires			x		x	x
Pathological assessment, if surgery					x

CCRT concurrent chemoradiation, CMT chemotherapy, EGD esophagogastroduodenoscope, CT computed tomography, PET positron emission tomography, QOL quality of life
^aPre-study should be completed within 6 weeks prior to study entry (radiation start)
^bShould be taken within 14 days prior to study entry
^cRequired if the tumor is above the carina with suspected tracheoesophageal fistula
^dCT ≤ 6 weeks prior to study entry. Treatment planning CT scan ≤ 3 weeks prior to radiation
^ePET/CT scan and endoscopic ultrasound are optional. Bone scan is considered in patients who cannot perform PET/CT scan to exclude bone metastasis
^fIf clinically indicated
^gEvery 3 months × 3 visits, then every 6 months × 2 visits, then yearly

ISSN: 1745-6215