A single center, phase 2 study to evaluate safety and efficacy of total neoadjuvant treatment of short course radiotherapy followed by chemotherapy, capecitabine combined with oxaliplatin (CAPOX) for locally advanced rectal cancer

JRCT ID: jRCTs051200113

Registered date:19/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 19/01/2021
• Target sample size: 27
• Study type: Interventional

Intervention(s)

Neoadjuvant radiation therapy : 5Gyx5
Neoadjuvant chemo therapy : CAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles
Operation: Total methorectum excision wiht radical lymph node dissection

Outcome(s)

• Primary Outcome: Pathological complete response: pCR

Secondary Outcome

Clinical complete response (cCR) rate (the state of disappearance on the image is defined as cCR)
Radical resection rate
Recurrence type
Relapse-free survival (RFS)
Overall survival (OS)
Preoperative treatment-related adverse event occurrence rate judged by CTCAE ver4.0
Protocol treatment completion rate
Radiation therapy completion rate
Chemotherapy completion rate
Intraoperative safety evaluation (intraoperative complications judged by CTCAE ver4.0)
Postoperative safety evaluation (postoperative complications judged by CTCAE ver4.0 and Clavien-Dindo classification)

Key inclusion & exclusion criteria

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

Include criteria

1)Written informed consent obtained
2)Histological diagnosis of primary colorectal adenocarcinoma.
3)No distance metastases with CT or PET
4)Age >= 20 year old.
5)ECOG 0 or 1. If Age >= 75 year old, ECOG 0.
6)Treatment-naive patients with rectal cancer and clinically resectable rectal cancer located within 12cm from their anal verge.
7)Clinical stage of cT3-4 N0 M0 or TanyN+M0
8)Sufficient organ functions

Exclude criteria

1. Received one of the following treatments,
a. Extensive surgery within 4 weeks (excluding CV port)
b. Any anti-cancer drug treatment within 4 weeks
c. Irradiation within 4 weeks
2. Have a complication or history of severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.).
3. Cases with a colon stent for stenosis
4. Cases with serious comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, etc.)
5. Cases with active multiple cancers (simultaneous multiple cancers or metachronous multiple cancers with a disease-free period of 5 years or less). However, cancer in situ (carcinoma in situ) or lesions equivalent to intramucosal cancer that are cured by local treatment are not considered to be active multiple cancers.
6. Pregnant women, lactating women, positive pregnancy tests, or no intention of contraception.
7. Have Hbs antigen positive or HCV antibody positive
8. Have a known human immunodeficiency virus (HIV) infection.
9. In addition, the investigator or research coordinator judges that it is inappropriate for this study.

Related Information

• Primary Sponsor: Kagawa Yoshinori
• Secondary ID(s): ,