| Objective: |
Compare overall survival rates in patients with rectal cancer and unresectable metastasis, surgically treated or not for their primary rectal tumor. |
| Aim: |
Exclusive systemic chemotherapy is most often used to treat patient with rectal cancer and unresectable metastasis. During this treatment, patients may require emergency surgery to treat complications related to the primary (obstruction, bleeding or perforation). Such unplanned operations are associated with higher operative morbidity and mortality to scheduled procedures for stage IV disease. Many surgeons have advocated resection of the primary mainly to avoid these complications however this surgery may delay the start of chemotherapy. Some studies reported that resection of the primary in case of unresectable metastatic disease prolonged survival. These studies were non-randomized and the majority were single-centre and retrospective. The major drawback of these non-randomized studies was that the patients selected for surgery were those with a better performance status and better prognosis. Furthermore, the impact of primary tumor resection on quality of life has not been assessed. All published studies included colon and rectal cancers, but the issues are different for these two localizations. Surgery for rectal cancer seems more complex and may result in increased morbidity and postoperative functional disorders (stoma, digestive, sexual, urinary) compared to colonic surgery. On the other hand, symptoms related to the progression of rectal tumor are often severely disabling (pain, rectal syndrome) and difficult to control. |
| Methods: |
This study is a multicentre randomized open-label controlled trial aimed to evaluate the impact on survival of the primary tumor resection in rectal cancer with unresectable synchronous metastasis (Figure 1- Flow chart study). Patients will be randomly assigned in a 1:1 ratio to Arm A: primary tumor resection followed by systemic chemotherapy versus Arm B: systemic chemotherapy alone. |
| Reason for International Trial: |
There are advantages and disadvantages with both tumor resection and chemotherapy alone. There is a need to perform a randomized trial evaluating the impact of primary tumor resection on survival in patients with rectal cancers and unresectable synchronous metastases. Moreover, quality of life is a critical aspect of palliative treatments which has never been specifically investigated. Quality of life may be impacted by both the symptoms and complications relating to the rectal cancer itself and by primary tumor resection. Whether or not resection of the primary tumor in palliative care is beneficial remains a clinical dilemma. To date, no randomized trial has assessed the impact of primary tumor resection on overall survival and quality of life in patients with CRC and unresectable metastases. GRECCAR 8 is a dedicated prospective randomized study looking into the specific problem of rectal cancer to evaluate the impact of primary tumor resection in rectal cancer with unresectable metastases. |
