Neoadjuvant short-term radiotherapy followed by surgery versus surgery alone for patients over 70 years of age with local advanced rectal cancer and who are medically unfit for standard neoadjuvant radiochemotherapy treatment

NEROP-RC (NEoadjuvant Radiotherapy for Older Patients ? Rectal Cancer): a randomised controlled phase III study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74475000

Enrollment

800

Registered

2012-10-16

Start date

2013-01-01

Completion date

Unknown

Last updated

2017-04-24

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

Conditions

Optimal therapy for patients > 70 years with rectal cancer Cancer Malignant neoplasm of rectum

Interventions

All patients over 70 years of age and having preoperatively diagnosed locally advanced rectal cancer (uT1-3 and/or uN1-2), for whom the neoadjuvant standard RCT appears to present too high a risk, are

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary diagnosis of histologically bioptically secured diagnosis of rectal cancer 2. Rectal cancer at any height (up to 16cm lower edge of tumor measured from the anal line using inflexible rectoscopy) 3. Decision made by the treating tumor team that intensified RCT is not possible 4. Preoperative tumor staging max. uT1-4uN1-2M0 5. Age >/= 70 years 6. Karnofsky index >/= 70% 7. ASA-classification < IV 8. Oral and written consent according to 9. Good Clinical Practice and corresponding local, national and international regulations

Exclusion criteria

Exclusion criteria: 1. Other previous cancer illnesses with the exception of appropriately treated in situ carcinoma of the cervix or skin tumors with no indication of melanoma or in cases of tumor-free state = 10 years subsequent to appearance of cancer which has undergone appropriate treatment 2. Participation in studies elsewhere which include chemotherapy or radiotherapy 3. Inability to participate in regular check-ups

Design outcomes

Primary

Measure	Time frame
Superiority of preoperative radiotherapy (5x5Gy) followed by TME and abdomino-sacral rectum extirpation in patients over 70 years of age with locally advanced rectal cancer up to a maximum of uT1-4N1-2M0 versus surgery alone with TME or abdomino-sacralen rektum extirpation with respect to locoregional control.	—

Secondary

Measure	Time frame
1. Disease-free survival (DFS) (first case of tumor illness locoregional or distant metastases) 2. Occurrence of distant metastases 3. Frequency of other, non-tumor-related deaths 4. Determination for comorbidity based on the Charlson ? Index and the ADL Index 5. Determination of how often chemotherapy can be performed postoperatively 7. Acute and long-term toxicity of preoperative radiotherapy 8. Overall survival (OS)	—

Measure

Time frame

1. Disease-free survival (DFS) (first case of tumor illness locoregional or distant metastases) 2. Occurrence of distant metastases 3. Frequency of other, non-tumor-related deaths 4. Determination for comorbidity based on the Charlson ? Index and the ADL Index 5. Determination of how often chemotherapy can be performed postoperatively 7. Acute and long-term toxicity of preoperative radiotherapy 8. Overall survival (OS)

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026