Preoperative radiotherapy for advanced rectal cancer: a prospective observational study

Preoperative radiotherapy for advanced rectal cancer: a prospective observational study - Preoperative radiotherapy for advanced rectal cancer: a prospective observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044067

Enrollment

Registered

2021-04-28

Start date

2021-04-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed rectal adenocarcionma 2. Resectable rectal cancer with cT3-4N1-2M0-1 (UICC 8th ed.) 3. 20- years 4. Performance Status: 0-1 5. No previous pelvic radiotherapy 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Uncontrollable comorbidity 3. Previous pelvic radiotherapy 4. Other

Design outcomes

Primary

Measure	Time frame
2-year local-regional control rate	—

Secondary

Measure	Time frame
cumulative local-regional control rate, relapse-free survival, overall survival, failure pattern, accumulated local recurrence rate, treatment completion rate, safety (operative complications, late adverse events), nutritional status, R0 resection rate, immunohistochemical assessment, down-staging rate, pathological response rate, response rate (RECIST version1.1), cCR, pCR, imaging, treatment planning, IGRT, errors in radiotherapy.	—

Measure

Time frame

cumulative local-regional control rate, relapse-free survival, overall survival, failure pattern, accumulated local recurrence rate, treatment completion rate, safety (operative complications, late adverse events), nutritional status, R0 resection rate, immunohistochemical assessment, down-staging rate, pathological response rate, response rate (RECIST version1.1), cCR, pCR, imaging, treatment planning, IGRT, errors in radiotherapy.

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Countries

Japan

Contacts

Public ContactSaori Imamura

Kindai University Faculty of Medicine Department of Radiation Oncology

saorin823st@med.kindai.ac.jp072-288-7222

Outcome results