A Feasibility Study of definitive radiotherapy with FOLFOX for Esophageal Cancer

JRCT ID: jRCTs031220219

Registered date:20/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 05/10/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Chemotherapy (FOLFOX:5-FU+I-LV+L-OHP) 1 course 2 weeks x 3 courses with concurrent radiation(60Gy/30fr).

Outcome(s)

• Primary Outcome: The incidence of DLT up to 1 year after the start of protocol treatment
• Secondary Outcome: Overall survival, progression-free survival, treatment completion rate, adverse event rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma by endoscopic biopsy of the primary esophageal tumor.
2) CT images show that the tumor is unresectable.
That is, one of the following applies
i. Wall depth of the primary tumor is T4
ii. Involvement of other organs via regional lymph node metastasis
iii. Progression after preoperative or induction chemotherapy that meets i-ii above
3) No distant organ metastasis on CT imaging, except for lymph node metastasis in the supraclavicular fossa if the primary lesion is in the upper chest, lymph node metastasis in either the supraclavicular fossa or periclavicular lymph nodes if the primary lesion is in the mid-thoracic region, or lymph node metastasis in the periclavicular lymph nodes if the primary lesion is in the lower chest.
4) Age is 18 years or older.
5) ECOG PS less than or equal to 2
6) No previous radical surgery for esophageal cancer except for endoscopic submucosal dissection
7) No history of radiation therapy to the chest
8) Meet the following laboratory requirements (latest values within 28 days prior to enrollment)
i. Neutrophil count more than or equal to 1,500/mm3
ii. Platelet count more than or equal to 100,000/mm3
iii. CCr more than or equal to 30ml/min/body
iv. Serum total bilirubin less than or equal to 3.0 mg/dL
v. SpO2 (room air) more than or equal to 90%
9) Unsuitable or unwilling to receive FP-RT as standard treatment
10) Written consent for participation in the study has been obtained from the patient

Exclude criteria

1) Have active multiple cancers (concurrent multiple cancers and heterogeneous multiple cancers with a disease-free interval of 3 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in active multiple carcinoma.
2) Patients with poorly controlled diabetes mellitus.
3) Patients with poorly controlled hypertension
4) Patients with any of the following conditions requiring treatment: coronary artery disease, cardiomyopathy, heart failure, and arrhythmia.
5) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema
6) Patients with active infections
7) Pregnant or potentially pregnant women, and lactating women
8) Patients with concomitant psychiatric disorders or psychiatric symptoms who are judged by the pri
ncipal investigator or sub-investigator to be unable to participate in the study
9) Patients who are deemed unsuitable for participation in the study by the investigators for any other reason.

Related Information

• Primary Sponsor: Miura Akinori