Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723253
• Other study ID #: TOMOX Rectal Study
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2016
• Last updated: March 29, 2016
• Start date: January 2005
• Est. completion date: February 2012

Study information

• Verified date: March 2016
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2012
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Radiation:
• Radiotherapy
Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV. The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC). A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction. Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.

Drug:
• Tom-OX
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system.	Pathologic responses of the primary tumours were defined according to the Mandard regression grading system: grade 1 was recorded when no tumour cells remained in the primary tumour and lymph nodes (pCR); grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis; grade 3 was characterized by an increase in the number of residual cancer cells, but fibrosis still predominated; grade 4 showed residual cancer outgrowing fibrosis; and grade 5 was characterized by an absence of regressive changes. Good responders were defined those patients with a pathologic response with Mandard G1 or G2 and poor responder patients with Mandard G3, G4 or G5.	8 weeks after chemo-radiotherapy	No
Secondary	Number of patients in which a surgical resection was feasible		8 weeks after chemo-radiotherapy	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v3.0	CTCAE v 3.0 was used to score acute and late radiation toxicity.	Up to 36 months. In details, follow-up examinations were performed 4 weeks after surgery and every 6 months until the established length of follow-up or death.	Yes
Secondary	The number of patients without disease (i.e. rectal cancer) during the follow-up.	The disease-free survival (DFS) was defined as the time from the diagnosis to the documented local or distant recurrence or last follow-up.	Up to 36 months.	No
Secondary	The number of patients still alive at the end of follow-up	The overall-survival (OS) was defined as the time from the diagnosis until death for any cause or the last follow-up.	Up to 36 months	No