Status: Closed
Activation Date: 2017AUG22
Closing Date: 2020MAY19
Phase: II
Description: NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial
Eligibility: - Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment. - Tumour stage cT1-T3abN0 based on pelvic MRI - cN0 stage based on pelvic MRI - No contraindications to protocol chemotherapy - M0 stage based on no evidence of metastatic disease by CT imaging - Mid to low-lying tumor eligible for local tumor excision in the opinion of the treating surgeon - Medically fit to undergo radical surgery as per treating surgeon's discretion - Patient does not have pathologic high risk factors on either/ or the initial biopsy specimen report or follow up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion
Objective: Protocol specified organ preservation rate
Participation: Limited to invited centres
Lay Description: The purpose of this study is to find out the effects of chemotherapy followed by less invasive surgery on participants with early rectal cancer. The standard or usual treatment for this disease is to remove the whole rectum by surgery, including the tumour and lymph nodes in the area. Complications after this type of surgery are common. Less invasive surgery removes the tumour but does not remove all the lymph nodes. Chemotherapy given before the less invasive surgery would treat tumour that has spread to lymph nodes in the area. It can also help prevent the cancer from spreading further. This study uses a combination of three drugs (5-fluorouracil, leucovorin and oxaliplatin) called FOLFOX or a combination of two drugs (capecitabine and oxaliplatin) called CAPOX. The approach of this trial will be considered a success if at least 65% of participants are able to keep the rectum.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | CO28 | 58 | 34 | 39 | 49 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | CO28 | 58 | 1 | 3 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | CO28 | 58 | 58 | 0 | 0 | 0 | 54 | 53 | 0 | 0 |