Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Completed; Phase 2

Conditions: Rectal Neoplasms

Treatments: Radiation: Radiotherapy; Drug: Tom-OX

Study type: Interventional

Funder types: Other

Identifiers

NCT02723253

TOMOX Rectal Study

Details and patient eligibility

About

Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival.However, patients with T4 rectal cancer show high risk of local recurrence after conventional treatment. Therefore investigators designed a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy.

Full description

Neoadjuvant chemoradiation (CRT), is considered the standard treatment of locally advanced rectal cancer with a positive impact on locoregional control and survival. However, patients with T4 rectal cancer show high risk of local recurrence (LR) after conventional treatment. This was a prospective Phase II study on patients with locally advanced rectal cancer or locally recurrences, to evaluate the efficacy in terms of pathological response and resectability of concomitant boost RT (55 Gy/5 weeks) with concurrent Raltitrexed and Oxaliplatin (Tom-Ox) chemotherapy. The primary aim was to assess the pathological complete response rate. Key secondary aim was the resectability. Secondary aims were evaluation of treatment-related acute and late toxicity, local control, disease-free survival and overall survival (OS). The follow-up period of each subjects started after the radiochemotherapy treatment and ended after a maximum of 36 months of observation or until death.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven locally advanced (T4N0-2) or locally recurrent rectal adenocarcinoma;
• Age ≥ 18 years;
• Eastern Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Exclusion criteria

• Metastatic patients
• unfit surgery patients,
• pregnant or breast feeding females
• patients with clinically detectable ascites

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

Radiotherapy plus Tom-Ox

Experimental group

Description:

Patients received concomitant boost RT (55 Gy/5 weeks) with concurrent Tom-Ox chemotherapy. The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.

Treatment:

Radiation: Radiotherapy

Drug: Tom-OX