Personalized treatment of rectal cancer with induction chemotherapy, radiation therapy and consolidation chemotherapy

JRCT ID: jRCTs021210076

Registered date:16/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 11/05/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Induction and consolidation chemotherapy:
Oxaliplatin 130mg/sqm over 2 hours, day1.
Capecitaine according to the body surface area (refer to the following) twice daily days1-15 every 3 weeks. Repeat 3 cycles.
Single dose <1.36sqm, 1200mg. 1.36sqm=< and 1.66sqm>, 1500mg. 1.66sqm=< and 1.96sqm>, 1800mg. >1.96sqm, 2100mg.

Radiotherapy:
25Gy in 5 fractions to the pelvis.

Surgery:
Surgery is performed as soon as possible (after recovery from adverse effects of chemotherapy) if the patient is judged effective within 4 weeks after the last dose of induction chemotherapy and is found to be negative for lateral lymph nodes, negative for CRM and EMVI, and cT3. Surgery is either sphincter function-preserving (low anterior resection, intersphincteric resection) or non-sphincter function-preserving (Hartmann's operation, abdominoperineal resection), but the details of the procedure are determined based on patient factors. For patients with lateral lymph node metastasis, lateral lymph node dissection of the side with lymph node metastasis before treatment should be performed. In cases of stenosis, induction chemotherapy should be given after loop stoma construction. The choice of approach (open, laparoscopic, or robot) and diverting stoma construction is left to each institution.

Postoperative therapy:
In the case of induction chemotherapy alone, 5 courses of capecitabine are administered as postoperative adjuvant chemotherapy. In the case of induction chemotherapy, radiation therapy and consolidation chemotherapy, no postoperative treatment is given.

Outcome(s)

• Primary Outcome: 3-year disease-free survival rate
• Secondary Outcome: Overall survival, pCR rate, R0 rate, local recurrence rate, completion rate of preoperative treatment, incidence rate of adverse events, and incidence rate of surgical complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically confirmed rectal adenocarcinoma.
2) Tumor lower margin is located at rectum (RS, Ra, Rb, P).
3) High-resolution MRI scan is available and any of the following factors are present.
Lateral lymph node metastasis, positive CRM, cT4, positive EMVI.
4) No distant metastasis.
5) Eastern Cooperative Oncology Group performance status (PS) 0-1.
6) Age at enrollment must be 20 years or older.
7) Adequate hematological, hepatic, renal and metabolic function parameters.
8) Written informed concent.

Exclude criteria

1) Active multiple cancers (intraepithelial cancer is acceptable).
2) Contraindications to MRI (pacemaker, cerebral artery clipping, etc.)
3) Patients with myelosuppression (neutrophil count <1,500/mm3, platelet count <100,000/mm3).
4) Patients with severe renal impairment (Creatinine Clearance <30mL/min).
5) History of chemotherapy for the target disease.
6) Prior radiation therapy in the pelvic region.
7) Drug hypersensitivity to study medications.
8) History of major surgery (implantable central venous reservoir, stoma construction is acceptable) within 28 days prior to enrollment.
9) History of clinically serious cardiovascular disease (myocardial infarction, unstable angina, heart failure, stroke, pulmonary embolism, other thromboembolism, etc.) within 6 months prior to enrollment.
10) Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, liver failure, active infection, etc.).
11) Pregnant women, lactating women, and men who may be or intend to become pregnant, or whose partners wish to become pregnant.
12) Other patients who are judged by the study physician to be inappropriate for the safe conduct of this study.

Related Information

• Primary Sponsor: Miura Takuya