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Guideline Summary
Guideline Title
The role of IMRT in gastrointestinal cancers.
Bibliographic Source(s)
Wong RKW, Rumble RB, Warde P, IMRT Indications Expert Panel. The role of IMRT in gastrointestinal cancers. Toronto (ON): Cancer Care Ontario (CCO); 2010 Oct 29. Various p. (Evidence-based series; no. 21-3-10).  [28 references]
Guideline Status

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site External Web Site Policy for details on any new evidence that has emerged and implications to the guidelines.

Scope

Disease/Condition(s)

Gastrointestinal (GI) cancers including:

  • Anal cancer
  • Gastric cancer
  • Esophageal cancer
  • Rectal cancer
  • Pancreatic cancer
  • Liver cancer
  • Cholangiocarcinoma
Guideline Category
Assessment of Therapeutic Effectiveness
Treatment
Clinical Specialty
Gastroenterology
Oncology
Radiation Oncology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Other
Patients
Physician Assistants
Physicians
Guideline Objective(s)

To evaluate if there is a benefit associated with the use of intensity modulated radiation therapy (IMRT) compared with three-dimensional conformal radiation therapy (3DCRT) in the treatment of the following cancers: anal, gastric, esophageal, rectal, pancreatic, liver cancer, and cholangiocarcinoma

Target Population

Adult patients with gastrointestinal (GI) cancers who are being considered for radiation treatment

Interventions and Practices Considered

Intensity modulated radiation therapy (IMRT) versus three-dimensional conformal radiation therapy (3DCRT)

Major Outcomes Considered
  • Treatment-related outcomes including:
    • Local tumour control
    • Local and regional nodal recurrences
    • Distal metastasis
    • Overall or disease-free survival
    • Dosimetry comparison between intensity modulated radiation therapy (IMRT) and three-dimensional conformal radiation therapy (3DCRT) to organs at risk
  • Acute and late adverse effects

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Literature Search Strategy

The MEDLINE and EMBASE databases were searched for evidence on gastrointestinal (GI) cancers and intensity-modulated radiation therapy (IMRT) on March 20, 2009. In both databases keywords for "gastrointestinal cancer", "gastrointestinal neoplasms", or "digestive system cancer" were combined with keywords for "intensity-modulated radiotherapy" and the following terms were excluded: "brachytherapy", "proton therapy", "biological markers", "gene therapy", "children", "childhood cancer", "pediatric cancer", "quality assurance", "treatment plan comparison", "aperture optimization", "independent dose calculation", "EPID dosimetry", and "set up errors." Results were limited to those published in English from the year 2000 to the current date in 2009 (see Appendix 2 in the original guideline document for literature search strategies).

A search for clinical practice guidelines (CPG), systematic reviews (SR), and health technology assessments (HTA) was also performed. A search of the National Guideline Clearinghouse (located at: http://www.guideline.gov External Web Site Policy) was performed on March 9, 2009. Additionally, a search of the MEDLINE and EMBASE databases was performed on March 25, 2009, using keywords for IMRT in combination with terms for all disease sites, limited to review articles published after 2000. Finally, the Scottish Collegiate Guidelines Network (SIGN) (located at: http://www.sign.ac.uk External Web Site Policy), the National Institute for Health and Clinical Evidence (NICE) (located at: http://www.nice.org.uk External Web Site Policy), and the Agency for Healthcare Research and Quality (AHRQ) (located at: http://www.ahrq.gov External Web Site Policy) were searched on March 25, 2009, using keywords for "IMRT" and "radiation" in combination with disease-site specific terms.

Study Selection Criteria

Inclusion Criteria

Eligible publication types must include comparative data on IMRT versus 3DCRT in the treatment of the included GI cancer subsites and report on at least one of the outcomes of interest.

Eligible publication types include:

  • CPGs, SRs, HTAs
  • Randomized phase II or phase III trials
  • Dose escalation studies, toxicity reports, quality of life (QoL) reports, case series, and retrospective studies
  • Reports having 50 or more patients
  • Publications in English
  • Publications in the year 2000 to current date

Exclusion Criteria

  • Published in a language other than English
  • Do not provide comparative data
  • Reports on fewer than 50 patients
  • Published prior to 2000

Ongoing Trials

The U.S. National Institutes of Health online directory of clinical trials (located at http://www.clinicaltrial.gov External Web Site Policy) was searched on September 30, 2009 for listings of relevant trials. The details of the single relevant study on IMRT in the treatment of anal cancer appear in Table 2 of the original guideline. No studies were found examining the use of IMRT in other GI cancers.

Number of Source Documents

The MEDLINE and EMBASE searches returned 60 and 140 potential articles, respectively. After removing ineligible articles based on title and abstract review, 19 were ordered based on the MEDLINE results, and 15 were ordered based on the EMBASE results (34 articles in total were ordered for full-text review). In addition to these 34 articles, one abstract from the conference proceedings of the American Society for Therapeutic Radiology and Oncology (ASTRO) was also ordered for full-text review. After removing ineligible articles based on the title and abstract review, none of the remainder was ordered for full-text review. No evidence meeting the inclusion criteria was found in this systematic review, and all included results, discussion, and conclusions are based on historical evidence along with expert opinion only.

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

No statistical analyses were planned in this systematic review; however, this would be considered if data were to allow.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The Evidence-Based Series (EBS) guidelines developed by Cancer Care Ontario's (CCO) Program in Evidence-Based Care (PEBC) use the methods of the Practice Guidelines Development Cycle. For this project, the core methodology used to develop the evidentiary base was the systematic review. Evidence was selected and reviewed by one member of the Intensity-Modulated Radiation Therapy (IMRT) Indications Expert Panel (see Appendix 1 in the original guideline document for Panel membership) and one methodologist.

Development and Internal Review

This EBS was developed by the IMRT Indications Expert Panel of the Cancer Care Ontario Program in Evidence-based Care/Radiation Treatment Program (CCO PEBC/RTP). The series is a convenient and up-to-date source of the best available evidence on the role of IMRT in central nervous system cancer, developed through review of the evidentiary base, evidence synthesis, and input from external review participants in Ontario.

IMRT Expert Panel Conference

On December 3, 2009 the IMRT gastrointestinal (GI) cancers guideline was presented to members of the IMRT Expert Panel (N=27) and feedback was obtained on the quality and comprehensiveness of the evidence and the recommendations.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Report Approval Panel

Following the presentation of this Evidence-based Series (EBS) draft report for Expert Panel review, the report was submitted to the Program in Evidence-based Care (PEBC) Report Approval Panel (RAP) on March 8, 2010 for review. The RAP is comprised of two members, including an oncologist, with expertise in clinical and methodological issues.

External Review: Professional Consultation

On September 20, 2010 the RAP-approved document was distributed to clinicians practicing within the Province of Ontario as part of a Profession Consultation review process. A total of 126 clinicians were invited to participate, and a total of 12 submitted responses (9.5% response rate).

Recommendations

Major Recommendations

No evidence meeting the inclusion criteria was obtained in this systematic review; therefore, it is not possible to propose recommendations informed by evidence.

Qualifying Statements

  • To date there are insufficient clinical outcome study data comparing intensity modulated radiation therapy (IMRT) with three-dimensional conformal radiation therapy (3DCRT) in the treatment of gastrointestinal (GI) cancers. However, evidence from 19 non-comparative dosimetric and outcome studies has suggested that IMRT is an option for esophageal, gastric, bile duct, pancreatic, rectal, and anal cancers. These studies have demonstrated that IMRT can reduce radiation dose to organs at risk (OAR), while managing to deliver the prescribed radiation dose to target volumes. For this reason, IMRT may be considered a viable treatment option, as it is ethical to recommend a treatment with little known harm over one with greater expected harm prior to scientific proof of the difference in harm being established. Earlier clinical data from small studies have reported lower treatment toxicities but have not been sufficient to suggest either superiority or inferiority of local tumour control within the target volumes.
  • No evidence was obtained on liver cancer.
  • The developers suggest that IMRT be considered for those patients with GI cancers where 3DCRT cannot adequately protect OAR (OAR management is site specific). Strict quality assurance in planning and treatment delivery should be implemented, with particular attention to dose inhomogeneity (hot and cold spots) within target volumes and OAR volumes, machine physical parameters, control of organ motions, and patient-positioning reproducibility during radiation and between fractions.
  • Prospective clinical data including tumour control, and treatment toxicities with dosimetric correlations should be maintained and regularly audited to critically evaluate the experience of IMRT in treating selected patients with GI cancers.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

All included results, discussion, and conclusions are based on historical evidence along with expert opinion only.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Studies have demonstrated that intensity-modulated radiation therapy (IMRT) can reduce radiation dose to organs at risk (OAR) while managing to deliver the prescribed radiation dose to target volumes. The OAR that could be spared from the damaging effects of unintended radiation through the use of IMRT are the lungs, heart, and spinal cord for esophageal cancer; the small bowel and right kidney for pancreatic cancer; the small bowel, liver, kidney, and spinal cord for gastric cancer; the liver and both kidneys for bile duct cancer; and the femoral head, small bowel, perineal skin, and bladder (but not the bone marrow) for rectal and anal cancer.

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements

Care has been taken in the preparation of the information contained in this report. Nonetheless, any person seeking to apply or consult the report is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding the report content or use or application and disclaims any responsibility for its application or use in any way.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Wong RKW, Rumble RB, Warde P, IMRT Indications Expert Panel. The role of IMRT in gastrointestinal cancers. Toronto (ON): Cancer Care Ontario (CCO); 2010 Oct 29. Various p. (Evidence-based series; no. 21-3-10).  [28 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Oct 29
Guideline Developer(s)
Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]
Guideline Developer Comment

The Program in Evidence-based Care (PEBC) is a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Source(s) of Funding

The Program in Evidence-Based Care (PEBC) and Radiation Treatment Program (RTP) are supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care Ontario. All work produced by the PEBC is editorially independent from its funding source.

Guideline Committee

IMRT Indications Expert Panel

Composition of Group That Authored the Guideline

Steering Panel: Dr. Padraig Warde, Provincial Head, Radiation Treatment Program, Cancer Care Ontario; Mr. Eric Gutierrez, Program Manager, Radiation Treatment Program, Cancer Care Ontario; Ms. Kate Bak, Project Coordinator, Radiation Treatment Program, Cancer Care Ontario; Mr. Bryan Rumble, Research Coordinator, Program in Evidence-based Care, Cancer Care Ontario

Expert Panel: Dr. Anthony Whitton, Radiation Treatment Program, Cancer Care Ontario; Ms. Sarah Etheridge, Radiation Therapy Representative, Peel Regional Cancer Program; Ms. Lisa Favell, Capital Project Representative, Cancer Care Ontario; Ms. Katrina Fleming, Radiation Therapy Representative, Grand River Regional Cancer Centre; Ms. Esther Green, Chief Nursing Officer and Director of Health Human Resource Planning, Cancer Care Ontario; Dr. Konrad Leszczynski, Physics Representative, Northeastern Ontario Regional Cancer Centre; Dr. Michael Sharpe, Physics Representative, Princess Margaret Hospital

Working Group: Dr. Raimond Wong, Associate Professor, Department of Oncology, Division of Radiation Oncology, McMaster University, Hamilton, ON

Financial Disclosures/Conflicts of Interest

No conflicts of interest were declared.

Guideline Status

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site External Web Site Policy for details on any new evidence that has emerged and implications to the guidelines.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

  • Program in evidence-based care handbook. Toronto (ON): Cancer Care Ontario (CCO); 2011. 15 p. Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on June 8, 2012.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please refer to the Copyright and Disclaimer Statements posted at the Program in Evidence-based Care section of the Cancer Care Ontario Web site External Web Site Policy.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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