Recruiting
Phase 3

Neo-Adjuvant Radiation

Sponsor:

International Atomic Energy Agency

Code:

NCT01459328

Conditions

Rectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy

Radiotherapy

Study Details

Brief summary:

This is a prospective, multicentre, randomized clinical trial comparing two different neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced adenocarcinoma of the rectum.

This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.

Conditions

Rectal Carcinoma

Study ID

NCT01459328

Start date

Sep, 2009

Status verified date

Oct, 2011

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • Clinical (i.e. surgical determination) and/or diagnostic image findings consistent with c/uT4 or CRM+ (note that CRM+ must be established by MRI), primary rectal Adenocarcinoma (i.e. histology consistent with origin from rectal mucosa); these constitute LARC for the purpose of this protocol
  • Treatment will be directed at the primary cancer, being clinically appropriate and given with an initial intent to cure the patient (this includes accepting up front that radiation and surgery are feasible; for surgery, this means that the patient has been determined fit for major surgery by an anaesthesiologist prior to the request for randomization)
  • Performance status is sufficient to undertake the treatment in either arm (KPS>50%)
  • Patient is accessible for required follow-up and data collection
  • Radiation oncologist expects survival to exceed 6 months from date of diagnosis
  • Patient provides informed consent

Exclusion Criteria:

  • Recurrent rectal cancer
  • Primary wholly in the sigmoid colon
  • Considered to be arising in the anal canal
  • Metastatic disease beyond the pelvis (by clinical assessment and/or diagnostic imaging)
  • Contraindications to protocol RT or to protocol chemotherapy, such as one or more of the following:
  • any prior RT to the pelvis; a solitary pelvic kidney within the intended radiation volume
  • consideration by the most responsible radiation oncologist that the treatment volume is too large, or the amount of small bowel or other critical organs within the treatment volume is too much for safe treatment
  • significantly abnormal laboratory tests such as impaired renal/liver function
  • a haemoglobin that is < 8.0 (or 80, SI) and the patient is not transfused to exceed 8.0 (or 80, SI)
  • on-going medications that are not compatible with protocol neo-adjuvant chemotherapy as described in this protocol
  • Significant development issues (such as with age < 18 yr)
  • Co-morbidity
  • Psychiatric diagnosis
  • Physical impairment
  • Pregnancy or continuing breast-feeding, that precludes administration of protocol treatments, or that precludes data collection (such as likely to preclude follow-up visits or completing questionnaires)

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A: Conventional Long Course Chemo-Radiation

Conventional long course chemo-radiation

experimental: Arm B: Short Course Radiation Followed by Chemotherapy

Experimental short course radiation followed by chemotherapy.

Interventions

Radiotherapy

Short course radiotherapy: 25Gy in 5 daily fractions over 1 week Chemotherapy: - Bolus 5 Fluorouracil 450 mg/m2/day

  • Injected Leucovorin 20 mg/m2/day for 5 days

Radiotherapy

Conventional long course chemo-radiation:

  • Radiation 50Gy in 25 daily fractions over 5 weeks
  • Bolus 5 Fluorouracil 350mg/m2/d for 5 days
  • Injected Leucovorin 20mg in both the first and last (5th) week of radiation
  • Oral Capecitabine (CAPE) 825mg/m2 b.i.d. during the entire radiotherapy course over 5 weeks.

Primary outcome measure

  • Overall Survival [ Time Frame: From commencement of radiation (day 1) to death or last follow-up up to 5 years. ]

Central Contacts and Locations

Locations

Credit Valley Hospital

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Jidong Lian

ombudsman@cvh.on.ca

Principal Investigator:

Jidong Lian

More Information

Sponsor

International Atomic Energy Agency

Last update posted

Oct 25, 2011

Last verified

Oct, 2011

Keywords

  • rectal carcinoma
  • long course chemo-radiation
  • short course chemo-rdiation
  • Locally Advanced Rectal Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by International Atomic Energy Agency on 2011-10-25.