Preoperative Chemoradiation With VMAT-SIB in Rectal Cancer (GRACE)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Completed; Phase 2

Conditions: Rectal Neoplasms

Treatments: Drug: XELOX; Radiation: VMAT-SIB

Study type: Interventional

Funder types: Other

Identifiers

NCT02745639

GRACE-RECTUM-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

VMAT-SIB + XELOX

Experimental group

Description:

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.

Treatment:

Drug: XELOX

Radiation: VMAT-SIB