NCT02745639

Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer

Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer: a Phase II Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective phase II study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX).

Detailed description

This was a prospective phase II study on patients with LARC or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with VMAT-SIB and two drugs chemotherapy ( XELOX). The primary aim was to asses the pathological response rate. Key secondary aim was the acute toxicity. Secondary aims were local control, disease-free survival (DFS) and overall survival (OS). The follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
RADIATION	VMAT-SIB	Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and OARs. Patients were treated only if the relative variations of the bone markers between the images were within 3 mm along the three spatial directions. Planning and delivery processes underwent to systematic independent-check procedures.
DRUG	XELOX	The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. An adequate blood count was necessary to start each chemotherapy infusion. Adjuvant chemotherapy was recommended on patients with high risk factors at pathological examination and decision was left to medical oncologists discretion.

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-11-01
• Completion: 2015-11-01
• First posted: 2016-04-20
• Last updated: 2016-04-20