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Status unknownNCT04499586Updated Aug 5, 2020

A Study of Radiotherapy Combined With Raltitrexed and Irinotecan in Metastatic or Locally Recurrent Colorectal Cancer

A Phase 2 interventional study of Radiotherapy Combined With Raltitrexed and Irinotecan in Recurrent Colorectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2019, registered Jul 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.

02

Conditions studied

  • Recurrent Colorectal Cancer

Keywords

  • Recurrent Colorectal Cancer
  • Irinotecan
  • Raltitrexed
  • Chemoradiotherapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 30 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-FU) and oxaliplatin refractory adenocarcinoma of the colon or rectum; Progression of disease within 6 months of receiving adjuvant 5-FU and oxaliplatin chemotherapy OR Progression of disease during or following completion of 5-FU and oxaliplatin chemotherapy for metastatic disease
  • Evaluable lesions with indications of radiotherapy
  • No other metastatic lesions in the radiation field
  • Karnofsky Performance Status>=70
  • UGT1A1*28 6/6 or 6/7
  • Subject blood routine and biochemical indicators meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L
  • Able to follow the protocol during the study period
  • Sign the inform consent

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
  • Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
  • Organ transplantation requires immunosuppressive therapy
  • Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
  • Anyone who is allergic to any research medication
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Radiotherapy Combined With Raltitrexed and Irinotecan

    Each cycle lasts 3 weeks. Administration of Raltitrexed and Irinotecan weekly followed by a 2 week 'rest' period with no drug given. Raltitrexed is given by IV infusion at a dose of 3mg/m2. Irinotecan is given by IV infusion at a dose of 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7).Radiation: 45-55Gy/25-30Fx

    Combination Product: Radiotherapy Combined With Raltitrexed and Irinotecan

Interventions

  • Combination productRadiotherapy Combined With Raltitrexed and Irinotecan

    Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7) per week. Radiation: 45-55Gy/25-30Fx

06

What researchers measure

Primary outcomes

  1. ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)

    Time frame: 20 weeks

Secondary outcomes

  1. DCR(Disease Control Rate)

    Time frame: 20 weeks

  2. PFS(Progression Free Survival)

    Time frame: 24 months

  3. the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0

    Time frame: 20 weeks

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200023, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04499586
Lead sponsor
Fudan University
Responsible party
Zhu Ji (professor, Fudan University) — Principal investigator
First posted
Aug 5, 2020
Start date
Jan 1, 2019
Primary completion
Aug 1, 2020
Completion
Dec 1, 2020 (estimated)
Last update
Aug 5, 2020

Study contacts

Zhen Zhang, MD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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