Resection of the primary tumor before Ctx vs. first-line Ctx in metastasized CRC

Not Applicable

• Conditions: C18; C19; Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction

• Registration Number: DRKS00003855
• Lead Sponsor: Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-04
• Study Completion: 2017-03-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Newly diagnosed, histologically confirmed colon cancer
2. Synchronous metastases not amenable for curative therapy; assessment by a local tumour board at each trial centre consisting of a surgeon, a medical oncologist or gastroenterologist and a radiologist
3. Resectable primary tumour
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
5. Adequate medical condition to tolerate surgery and/or chemotherapy
6. Age greater than or equal to 18 years
7. Given informed consent

Exclusion Criteria

1. Rectal cancer (tumor up to 12 cm from the anal verge)
2. Tumour related symptoms requiring urgent surgery
3. Patients not eligible for surgery (American Society of Anaesthesiologists [ASA] greater than or equal to IV)
4. Unequivocal extensive peritoneal metastases, i.e., lower gastrointestinal bleeding requiring transfusion, bowel obstruction, tumour perforation or intractable pain at site of primary tumour
5. Chemotherapy or radiotherapy during the past 6 months
6. History of another primary cancer. Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer or other primary solid tumour curatively treated with no known active disease present and no treatment administered for greater than or equal to 5 years prior to randomisation.
7. Expected lack of compliance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
1. Time-to-development of primary tumour complications (control arm), assessed until the end of the trial<br>2. Kind of primary tumour complications (control arm), assessed until the end of the trial<br>3. Need for intervention due to primary tumour complication (control arm), assessed until the end of the trial<br>4. Peri-operative morbidity (experimental arm) at 30 days after surgery<br>5. Peri-operative mortality (experimental arm) at 30 days after surgery<br>6. Interventions with curative intent (experimental and control arm), assessed until the end of the trial<br>7. Quality of life (EORTC QLQ C30 and CR29) at three months and six months after randomisation and then every six months