You are using an outdated browser. We suggest you update your browser for a better experience. Click here for update.
Close this notification.
Skip to main content Skip to search


Cancer Type: Gastrointestinal, Colorectal, Small bowel and appendix  Intent: Palliative
Regimen Category: Evidence-Informed
New Drug Funding Program
    Raltitrexed - Metastatic Colorectal Small Bowel or Appendiceal Cancer
A - Regimen Name

RALT Regimen

Disease Site
Gastrointestinal - Colorectal
Gastrointestinal - Small bowel and appendix


Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

Rationale and Uses

For treatment of metastatic colorectal, small bowel or appendiceal cancer.  Funded by NDFP for patients who have experienced unacceptable toxicity with 5-FU chemotherapy, or lives more than 60 km from the treatment centre/hospital or has special transportation needs.



Supplementary Public Funding

New Drug Funding Program (Raltitrexed - Metastatic Colorectal Small Bowel or Appendiceal Cancer) (NDFP Website)

B - Drug Regimen


(Round to nearest 0.1 mg)
3 mg /m² IV Day 1
back to top
C - Cycle Frequency


Until evidence of disease progression or unacceptable toxicity

D - Premedication and Supportive Measures

Antiemetic Regimen:


E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

Dosage in Myelosuppression ± Gastrointestinal Toxicity:

The dose of raltitrexed should be reduced based upon the worst hematologic and GI toxicity experienced in the previous cycle.  Doses should not be re-escalated if reduced for toxicity. 





Worst Toxicity in previous cycle



(% previous dose)

grade 3 neutropenia / thrombocytopenia
grade 2 GI toxicity
Hold until complete recovery
grade 4 neutropenia / thrombocytopenia
grade 3 GI toxicity
grade 3 or 4 ↑ LFTs
Hold until ≤ grade 2
100%; if recurs consider ↓ to 75%.
grade 4 GI toxicity
Discontinue treatment
grade 4 neutropenia / thrombocytopenia
grade 3 GI toxicity

1 Retreat only when GI toxicity resolved, platelets are ≥ 100 x 109/L, ANC ≥ 2 x 109/L, and WBC ≥ 4 x 109/L.





Hepatic Impairment

Initial Dose (baseline values)
100%, watch carefully
Extreme caution (no data)
Do not treat (no data)









Renal Impairment

Mild to moderate renal impairment results in a significant reduction in raltitrexed clearance and doses must be modified for renal impairment.  Patients with renal impairment should be monitored carefully. 

Creatinine Clearance (mL/min)

Dose as % of 3mg/m2

Dosing Interval








% equivalent to mL/min*




not applicable

*(e.g. if 30mL/min, give 30% of full dose.)

Dosage in the Elderly

Use with extreme caution as the elderly are more susceptible to toxicity.

F - Adverse Effects
Refer to raltitrexed drug monograph(s) for additional details of adverse effects

Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Myelosuppression ± infection, bleeding (may be severe)
  • Fatigue
  • Nausea/vomiting
  • Diarrhea (may be severe)
  • Anorexia, weigh tloss
  • ↑ LFTs (may be severe)
  • Abdominal pain
  • Constipation
  • Rash
  • Mucositis
  •  Arrhythmia
G - Interactions
Refer to raltitrexed drug monograph(s) for additional details
H - Drug Administration and Special Precautions

Refer to raltitrexed drug monograph(s) for additional details

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; baseline and regular
  • CBC, for patients who develop signs of GI toxicity; weekly
  • Liver function tests; baseline and regular
  • Renal function tests; baseline and regular
  • Clinical assessment of GI toxicity, rash, infection and bleeding; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

back to top
J - Administrative Information

Approximate Patient Visit
0.5 hour
Pharmacy Workload (average time per visit)
18.6 minutes
Nursing Workload (average time per visit)
36.667 minutes
K - References

Cocconi G, Cunningham D, Van Cutsem E. et al. Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. Tomudex Colorectal Cancer Study Group. J Clin Oncol 1998;16(9):2943-52.

Cunningham D, Zalcberg JR, Rath U, et al.  Final results of a randomised trial comparing 'Tomudex' (raltitrexed) with Fluorouracil plus leucovorin in advanced colorectal cancer. "Tomudex" Colorectal Cancer Study Group. Ann Oncol 1996;7(9):961-5.

Maughan TS, James RD, Kerr DJ, et al. Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomised trial. Lancet 2002;359(9317):1555-63.

National Comprehensive Cancer Network. Colon Cancer (Version 2.2017). Accessed June 30, 2017.

Raltitrexed drug monograph, Cancer Care Ontario.

October 2017 Modified disease site, NDFP forms, rationale/uses and references

back to top
M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.