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Status:

UNKNOWN

Resource-Sparing Curative Treatment for Rectal Cancer

Lead Sponsor:

International Atomic Energy Agency

Collaborating Sponsors:

Centre Anti Cancer Hopital Frantz Fanon

Hospital A.C. Camargo

Conditions:

Rectal Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 rectu...

Detailed Description

This phase III randomised clinical trial compares the outcome of two different neo-adjuvant radiation based treatments for locally advanced rectal carcinoma. This encompasses patients at risk for a po...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT01459328

Start Date

September 1 2009

Last Update

October 25 2011

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Centre Anti-Cancer, Hopital Franz Fanon

Blida, Algeria, 09000

2

Hospital A.C. Camargo, Fundacao Antonio Prudente

São Paulo, Brazil, 01509-010

3

Credit Valley Hospital

Mississauga, Ontario, Canada, L5M 2N1

4

Instituto Nacional de Cancerologia, Minesterio de Salud

Bogota D.C., Colombia