Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT02017704
Group ID:
EG000
Title:
IMRT and Capecitabine
Description:
Patients will receive IMRT along with capecitabine.
Followed by:
* Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
* 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles
Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine.
External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus
Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
4
Other Number Affected:
4
Other Number At Risk:
4
Study:
NCT02017704
Results Section:
NCT02017704
Adverse Events Module:
NCT02017704