Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer

NCT02723253 | Completed Phase 2

• 1 other identifier: TOMOX Rectal Study
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rectal Neoplasms

Keywords

rectal cancer; radiotherapy; chemotherapy; Raltitrexed; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Number of patients in which a surgical resection was feasible

  8 weeks after chemo-radiotherapy

• Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

  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.

• The number of patients without disease (i.e. rectal cancer) during the follow-up.

  Up to 36 months.

• The number of patients still alive at the end of follow-up

  Up to 36 months

Study Arms (1)

Radiotherapy plus Tom-Ox

EXPERIMENTAL

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.

Radiation: Radiotherapy; Drug: Tom-OX

Interventions

Radiotherapy RADIATION

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.

Radiotherapy plus Tom-Ox

Tom-OX DRUG

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.

Also known as: Tomudex ®, Eloxatin ®

Radiotherapy plus Tom-Ox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; raltitrexed; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals

Study Officials

• Alessio G Morganti, Prof

  Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: March 30, 2016
• Study Start: January 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2012
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share