Clinical trial NCT02151019: Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer
Official title: Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-05-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.

Detailed description: Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer.

Multiple randomised trials have proved pre-operative CRT and RT, compared to surgery alone, reduce local recurrence, even prior to optimal surgery, and may improve survival for T3 circumferential resection margin (CRM) negative patients.

This study aims to determine if 3-DCRT or IMRT result in lower incidence of grade 2 GI toxicities.

Acute toxicities will be assessed weekly during radiotherapy, and at 2 and 4 week post treatment.

Late toxicities will be assessed at 3, 6, 9, 12, 18, 24 months post treatment, and annually to 10 years.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing pre-operative pelvic chemo-radiotherapy for histologically confirmed rectal adenocarcinoma, with the following staging: cT3N0-2, cT4N0-2, cT(any)N1-2, cT(any)N(any) CRM at-risk \[AJCC version V\]
* Staging / imaging of pelvis with MRI, and CT Thorax/Abdomen
* No evidence of metastatic disease
* ECOG Performance Status 0 - 2
* Age \> or equal to 18 years
* Provision of written informed consent in line with ICH-GCP guidelines

Exclusion Criteria:

* Previous radiotherapy to the pelvic region
* Patients in whom induction chemotherapy has been delivered prior to chemo- radiotherapy
* History of inflammatory bowel disease
* Previous hip replacement
* Previous bowel surgery (excluding procedures/operations which would not result in small bowel adhesions - at the discretion of the Principal Investigator)
* Patients with other syndromes/conditions associated with increased radiosensitivity
* Any other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
* Pregnancy or lactation at the time of proposed randomisation
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol

Primary outcomes:
measure: Reduction in incidence of grade 2 or higher GI toxicity
timeFrame: 10 years
Secondary outcomes:
measure: Compare incidence of acute grade > 2 GU toxicity
timeFrame: 10 years
measure: Evaluate incidence of late GI and GU toxicity
timeFrame: 10 years
measure: Rate of loco-regional control
timeFrame: 10 years
measure: Assess quality of life
timeFrame: 10 years
measure: Rate of disease free survival
timeFrame: 10 years
measure: Estimate overall survival
timeFrame: 10 years
measure: Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4
timeFrame: 10 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Luke's Radiation Oncology Network at Beaumont Hospital
city: Dublin
country: Ireland
facility: St Luke's Centre for Radiation Oncology at St James Hospital
city: Dublin
country: Ireland
facility: St Luke's Centre for Radiation Oncology at St Lukes Hospital
Study officials:
affiliation: St Luke's Centre for Radiation Oncology
name: Dr Brian O'Neill, MD
role: PRINCIPAL_INVESTIGATOR
References: