Clinical trial NCT02723253: Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer
Official title: Concurrent Chemoradiation With Concomitant Boost In Locally Advanced Rectal Cancer: A Phase II Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Keywords: rectal cancer
radiotherapy
chemotherapy
Raltitrexed
Oxaliplatin
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of patients defined as good responders (G1 or G2) according to the Mandard regression grading system.
timeFrame: 8 weeks after chemo-radiotherapy
Secondary outcomes:
measure: Number of patients in which a surgical resection was feasible
timeFrame: 8 weeks after chemo-radiotherapy
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
timeFrame: 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.
measure: The number of patients without disease (i.e. rectal cancer) during the follow-up.
timeFrame: Up to 36 months.
measure: The number of patients still alive at the end of follow-up
timeFrame: Up to 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Division of Radiation Oncology, S.Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, Prof
role: STUDY_DIRECTOR
References: