Influence of primary tumour resection on the course of disease in patients with metastatic colon cancer and unresectable metastases

Conditions

Synchronous metastatic colon cancer not amenable for curative therapy Cancer Colon cancer

Nuh N. Rahbari, Sebastiano Biondo, Manuel Feißt, Thomas Brückner, Inga Rossion et al. (13 authors)

Journal of Clinical Oncology2022-06-0826 citations

10.1200/jco.2022.40.17_suppl.lba3507

The Role of Primary Tumor Resection in Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis: A Multicenter Randomized Controlled Trial

Eun Jung Park, Jeong‐Heum Baek, Gyu‐Seog Choi, Won Cheol Park, Chang Sik Yu et al. (15 authors)

Cancers2020-08-1656 citations

10.3390/cancers12082306

A randomized controlled trial comparing primary tumour resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 (iPACS study)

Konosuke Moritani, Yukihide Kanemitsu, Dai Shida, Kohei Shitara, Junki Mizusawa et al. (8 authors)

Japanese Journal of Clinical Oncology2019-11-1944 citations

10.1093/jjco/hyz173

Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS--a randomised controlled multicentre trial (ISRCTN30964555).

Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jäger D, Luntz SP, Englert S, Rossion I, Koch M, Büchler MW, Kieser M, Weitz J, SYNCHRONOUS trial group.

2012-04-0587 citations

10.1186/1471-2407-12-142

Interventions

Experimental arm: Surgical resection of the primary tumour prior to systemic therapy Control arm: Systemic therapy without previous resection of the primary tumour The duration of follow-up is 36 mon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed, histologically confirmed colon cancer and/or high rectal 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

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

Design outcomes

Primary

Measure	Time frame
Overall survival is measured by follow up visits every 6 months up to 36 months and documented by participating hospitals in the eCRF (QoL questionnaire, medical treatment record, laboratory values of tumour markers; in case of death additional information on date cause of death is required).	—

Secondary

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

Measure

Time frame

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

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Countries

Austria, Germany

Outcome results

None listed