Chemoradiotherapy and consolidation chemotherapy for lower rectal cancer

JRCT ID: jRCTs021190023

Registered date:25/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 27/04/2020
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Chemoradiotherapy followed by consolidation chemotherapy
Chemoradiotherapy
Radiotherapy:45-50.4Gy in 25-28 fractions (5 fractions per week) to the pelvis.
Chemotherapy: Capecitabine according to the body surface area (refer to the following) twice daily 5 days/week along the radiotherapy. Single dose <1.31sqm, 900mg. 1.31sqm=< and 1.64sqm>, 1200mg. >1.64sqm, 1500mg.

Consolidation chemotherapy
CAPOX: 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 6 cycles.
Single dose <1.36sqm, 1200mg. 1.36sqm=< and 1.66sqm>, 1500mg. 1.66sqm=< and 1.96sqm>, 1800mg. >1.96sqm, 2100mg.

Outcome(s)

• Primary Outcome: clinical complete response rate
• Secondary Outcome: 2 year clinical complete response rate, local regrowth rate, non-regrowth disease-free survival, overall survival, pathological complete response rate, down-staging rate, R0 rate, local recurrence rate after rectal resection, disease-free survival after rectal resection, defecation QOL, urination QOL, rate of definitive stoma

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 lower rectum or anal canal (Rb or P) and palpable by digital examination
3) High resolution MRI examination is possible and the risk factor of recurrence is noted
greater than 5mm spread from mucularis propria, lymph node metastasis, positive EMVI, positive CRM, positive intersphincteric plane
4) No distant metastases
5) Eastern Cooperative Oncology Group performance status (PS) 0-1
6) Aged 20 years and older
7) Adequate hematological, hepatic, renal and metabolic function parameters
8) Written informed concent

Exclude criteria

1) Tumor lower margin is located at middle rectum (Ra) and not palpable by digital examination
2) Tumor invading surrounding organs
3) Lateral lymph node metastasis (Diameter of short axis is equal to or greater than 5mm)
4) Distant metastasis
5) MRI contraindications (Pace maker, cerebral artery clipping etc.)
6) Myelosuppresion (neutrophil count < 1,500/mm3, platlet count < 100,000/mm3)
7) Serious renal dysfunction (Creatinine Clearance < 30mL/min)
8) History of chemotherapy fot rectal cancer
9) History of radiotheraphy to the pelvic region
10) Known allergic reactions on study medication
11) Major surgery within the last 4 weeks prior to enrolment
12) Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, congestive heart failure, brain stroke, pulmonary embolism, etc.) within the last 6 months before enrolment
13) Serious concurrent diseases (incl. Interstitial pneumoniae, pulmonary fibrosis, severe liver function disorders, active and uncontrolled infections, etc.)
14) Pregnant or lactating women, women who are capable of pregnancy and intend to get pregnant or men who want to get their partners pregnant
15) Physician will determine that the patient is inappropriate participate in this trail for the safety.

Related Information

• Primary Sponsor: Miura Takuya