A phase I trial of neoadjuvant DCF therapy for elderly esophageal cancer patients.

JRCT ID: jRCTs061240067

Registered date:08/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 08/10/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): For elderly patients aged 76 years or older with resectable advanced esophageal cancer, preoperative DCF therapy, consisting of docetaxel, cisplatin, and 5-FU, will be administered in three 3-week courses. Using a three-patient cohort method, the dose will be increased stepwise if no dose-limiting toxicity (DLT) is observed, to determine the optimal dose.

Outcome(s)

• Primary Outcome: DLT occurrence rate at each dose level
• Secondary Outcome: Safety and pathological response rate

Key inclusion & exclusion criteria

• Age minimum: >= 76age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. The patient has been diagnosed with squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma by endoscopic biopsy of the primary esophageal lesion (biopsy of secondary lesions is not mandatory, but if performed, the diagnosis must be squamous cell carcinoma, adenosquamous carcinoma, or basaloid carcinoma).

2. All esophageal lesions (primary lesion, intramural metastasis, intraepithelial extension) are confined to the thoracic and abdominal esophagus (UICC-TNM 8th edition). However, secondary lesions eligible for EMR do not need to be confined to the thoracic or abdominal esophagus. If the esophagectomy is feasible, secondary lesions eligible for EMR in the cervical esophagus are also acceptable.

3. The clinical stage is cStage II, III, or IVA excluding T4, according to the TNM classification (UICC-TNM 8th edition).

4. The patient is 76 years or older at the time of registration.

5. The patient's performance status (PS) is 0 or 1 according to the ECOG criteria (PS must be recorded in the medical records).

6. The presence or absence of measurable lesions does not matter.

7. There is no history of treatment for esophageal cancer, except in the following cases:
-Curative resection by EMR/ESD resulting in pT1a-LPM (M2) or less.
-Curative resection by EMR/ESD resulting in pT1a-MM (M3) without vascular invasion.

8. There is no history of chemotherapy, radiotherapy, or endocrine therapy for any type of cancer. However, early cancer cases considered cured by endoscopic treatment are eligible. Prostate cancer cases with a history of hormone therapy are eligible if they have been disease-free for more than 5 years.

9. The latest test results within 14 days before registration (the same day of the week two weeks before the registration date is acceptable) meet all of the following criteria:
-White blood cell count: >=4,000 /mm3 and <=12,000 /mm3
-Platelet count: >=100,000 /mm3
-Hemoglobin: >=10.0 g/dL
-Total bilirubin: >=1.5 mg/dL
-AST (GOT): <=100 IU/L
-ALT (GPT): <=100 IU/L
-Serum creatinine: <=1.2 mg/dL
-SpO2: >=95% (room air)
-24-hour creatinine clearance (24hr-Ccr): >=50 mL/min/body

10. The patient is deemed suitable for curative esophagectomy (R0 resection) via thoracotomy (or thoracoscopic/robot-assisted surgery) and laparotomy (or laparoscopic/robot-assisted surgery).

11. The patient has provided written informed consent to participate in the study.

Exclude criteria

1. The patient has active double cancer (synchronous double cancer/multiple cancer and metachronous double cancer/multiple cancer with a disease-free period of 5 years or less). However, lesions equivalent to carcinoma in situ (intraepithelial cancer) or intramucosal cancer deemed cured by local treatment are not included as active double cancer/multiple cancer.

2. The patient has an active infection requiring systemic treatment (a fever of 38.0 degrees Celsius or higher, with bacterial infection proven by imaging or bacteriological examination). Localized infections not affecting the general condition are excluded.

3. HBs antigen, HCV antibodies, or HIV antibodies (registration is possible even if HIV antibodies have not been tested.

4.The patient has psychiatric disorders or mental symptoms that make participation in the trial difficult.

5. The patient is receiving continuous systemic steroid administration (oral or intravenous).

6. The patient requires continuous use of flucytosine (Ancotil, Domeclazine, Ancobon, Cocyl), phenytoin (Aleviatin, Hydantol, Phenytoin N), or warfarin potassium (Warfarin, Alepharin, Samofalon).

7. The patient has a history of hypersensitivity to DOC, CDDP, or polysorbate 80-containing preparations.

8. The patient has diabetes mellitus with HbA1c >=6.5% by JDS criteria (Japan Diabetes Society) or >=6.9% by NGSP criteria (National Glycohemoglobin Standardization Program) despite continuous use of insulin or oral hypoglycemic agents at the time of registration.

9. The patient has severe pulmonary emphysema or pulmonary fibrosis as determined by pulmonary function tests or CT.

10. The patient has uncontrolled hypertension.

11. The patient has unstable angina (angina that developed or worsened within the past 3 weeks) or a history of myocardial infarction within the past 6 months.

12. The patient has cirrhosis of the liver.

13. Other cases deemed unsuitable for participation in this study by the principal (or sub-) investigator.

Related Information

• Primary Sponsor: Hiroaki Nagano