Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer

Phase 2

Completed

• Conditions: Rectal Neoplasms
• Interventions: Radiation: VMAT-SIB; Drug: XELOX

• Registration Number: NCT02745639
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief 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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2013-11
• Study Completion: 2015-11
• Status Verified: 2016-04
• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-17
• Last Update Submitted: 2016-04-17
• Study First Posted: 2016-04-20
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

i) histologically proven rectal adenocarcinoma (cT3-4N0-2 or cT2N1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion Criteria

i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VMAT-SIB + XELOX	XELOX	A VMAT-SIB technique was used. 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 Organs at risks. 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.
VMAT-SIB + XELOX	VMAT-SIB	A VMAT-SIB technique was used. 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 Organs at risks. 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.

Primary Outcome Measures

Name	Time	Method
Pathological response rate	6-8 weeks after chemoradiotherapy	Pathological response was determined according to the TNM classification system of the American Joint Committee on Cancer. The complete resection of the tumor (R) with no histological proven residual disease in the surgical specimen, was defined as pathological complete response (pCR =pT0). Near complete response (pTmic) was defined as the presence of a number of neoplastic cells inferior to 10%.

Secondary Outcome Measures

Name	Time	Method
Acute Toxicity	During radiation treatment and at the first follow-up visit (4 weeks after RT).	To score acute toxicity CTCAE v.3.0 was used