Safety evaluation of combining short-course RT with preoperative treatment for esophageal cancer

JRCT ID: jRCT1061240036

Registered date:24/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 24/07/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Short-course radiotherapy (25 Gy/ 5fr) followed by two courses of preoperative chemotherapy with docetaxel (70 mg/m2/day, day 1), cisplatin (70 mg/m2/day, day1) and 5-FU (750 mg/m2/day, day 1-5) repeated every 3 weeks followed by surgery

Outcome(s)

• Primary Outcome: Perioperative complications within 30 days after surgery

Secondary Outcome

1. pCR rate in surgical cases
2. Percentage of cases that were inoperable
3. Assessment of adverse events during preoperative treatment
4. Rate of adverse events within 90 days after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. The main site of the primary tumor is in the thoracic esophagus
2. Histologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, or basaloid cell carcinoma
3. Clinical Stage II, III, IVA (exclude T4b), IVB (Only supraclavicular lymph node metastasis is allowed. However, excluding T4b) (UICC 8th)
4. Age 20-75
5. ECOG Performance status 0 or 1
6. No history of treatment other than endoscopic resection for esophageal cancer
7. No history of chemotherapy or radiation therapy, including for other cancers
8. Radical surgery for esophageal cancer is possible
9. Written informed consent for study participation was obtained from the patient

Exclude criteria

1. Have active infection requiring systemic treatment
2. Patients with active multiple cancers (synchronous multiple cancers/multiple cancers and metachronous multiple cancers/multiple cancers with a disease-free period of less than 5 years. However, even if the disease-free period is less than 5 years, clinical Stage I prostate cancer, clinical stage 0 or stage I laryngeal cancer that has had a complete response to radiation therapy, lesions equivalent to intraepithelial carcinoma or intramucosal cancer that have been determined to be cured after local treatment, Lesions diagnosed as intraepithelial carcinoma or intramucosal carcinoma of oropharyngeal cancer, hypopharyngeal cancer, gastric cancer, or colorectal cancer based on endoscopic findings before registration, as well as completely resected cancers with the following pathological stages: A history of cancer with a 5-year relative survival rate of 95% or higher is not included in active multiple cancers/multiple cancers). Gastric cancer "adenocarcinoma (general type)": stage 0-I, colon cancer (adenocarcinoma): stage 0-I, rectal cancer (adenocarcinoma): stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): stage 0, breast cancer (ductal carcinoma in situ, lobular carcinoma in situ): stage 0, breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): Stage 0-IIA, Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, Prostate cancer (adenocarcinoma): Stage I-II, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer Cancer (papillary carcinoma, follicular carcinoma): Stage I, II, III, Renal cancer (clear cell carcinoma, chromophobe cell carcinoma): Stage I, other lesions equivalent to intramucosal cancer. Stage classification is, in principle, Follow the UICC-TNM 8th edition or equivalent cancer treatment regulations.
3. Who are pregnant, may become pregnant, breastfeeding
4. Diagnosed with interstitial pneumonia
5. Serious heart disease or brain disease
6. Metastasis to other organs
7. The attending physician determines that the patient is unsuitable for this study.

Related Information

• Primary Sponsor: Noma Kazuhiro