Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Treatments: Oxaliplatin; Raltitrexed

Criteria

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