eoadjuvant 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

Recruiting

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

Registration Number: ISRCTN74475000

Lead Sponsor: South City Hospital Rostock (Klinikum Suedstadt Rostock) (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 800

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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