Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29 (ShorTrip)

  • STATUS
    Recruiting
  • End date
    Oct 30, 2028
  • participants needed
    63
  • sponsor
    Gruppo Oncologico del Nord-Ovest
Updated on 15 March 2022
Accepts healthy volunteers

Summary

The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.

Description

This is a prospective, open-label, multicentre, phase II single arm trial. Eligible patients with middle-high LARC will receive short-course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery.

The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)

Details
Condition Locally Advanced Rectal Cancer
Treatment Irinotecan, Oxaliplatin, 5-fluorouracil, TME, Lederfolin, Short-course Radiotherapy
Clinical Study IdentifierNCT05253846
SponsorGruppo Oncologico del Nord-Ovest
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent to study procedures and to translational analyses
Age 18-70 years
Histologically proven diagnosis of rectal adenocarcinoma
Patients with locally advanced rectal cancer defined by the presence of at least one of the following features
cN2 (defined as at least 4 positive lymphnodes at pelvic MRI)
cT4
tumor extending to within 1 mm of or beyond mesorectal fascia (i.e., circumferential radial margin threatened or involved)
cT3, N1
Distal border of the tumour located between 5 and 12 cm from the anal verge (as
measured by pelvic MRI)
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1
No evidence of metastatic disease by total body CT-scan
Available tumour samples at baseline (archival biopsy)
Tumour amenable to curative resection (including pelvic exenteration)
No history of invasive rectal malignancy, regardless of disease-free interval
No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma) or synchronous colon cancer
No clear involvement of the pelvic side walls by imaging
Life expectancy of at least 5 years (excluding diagnosis of cancer)
Hematopoietic function: absolute neutrophil count ≥ 1,500/mm3; platelet count
≥100,000/mm3; haemoglobin level ≥ 9 g/dL
Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN); alkaline phosphatase ≤ 2 times ULN; AST ≤ 2 times ULN
Renal function: creatinine clearance > 50 mL/min or serum creatinine 1.5 x UNL; no renal disease that would preclude study treatment or follow-up
Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy
However, in the absence of 12 months of amenorrhea, a single FSH measurement is
insufficient; - Subjects and their partners must be willing to avoid pregnancy during the
trial. Male subjects with female partners of childbearing potential and female subjects of
childbearing potential must, therefore, be willing to use adequate contraception
Contraception, starting during study screening visit throughout the study period up to 180
days after the last dose of chemotherapy. Note: Abstinence is acceptable if this is the
usual lifestyle and preferred contraception for the subject
Will and ability to comply with the protocol

Exclusion Criteria

Previous history of malignancy within the last 5 years will be excluded with the
exception of localized basal and squamous cell carcinoma or cervical cancer in situ
Patients with radiological evidence of distant metastases
Previous pelvic radiation therapy
Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria
Previous treatment with fluoropyrimidine and/or oxaliplatin and/or irinotecan
Patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of
the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT)
Treatment with any investigational drug within 30 days prior to enrolment or 2
investigational agent half-lives (whichever is longer)
Active uncontrolled infections or other clinically relevant concomitant illness
contraindicating chemotherapy administration
Clinically significant (e.g. active) cardiovascular disease for example
cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable
angina, New York Heart Association (NYHA) grade II or greater congestive heart failure
(CHF), serious cardiac arrhythmia requiring medication
Active inflammatory bowel disease (i.e., patients requiring current medical
interventions or who are symptomatic)
Partial or total colectomy
Pregnant or lactating women. Women of childbearing potential with either a positive or
no pregnancy test at baseline. Sexually active males and females (of childbearing
potential) unwilling to practice contraception during the study and until 180 days
after the last trial treatment
Known hypersensitivity to fluorouracil, oxaliplatin or irinotecan
Psychiatric or addictive disorders, or other conditions that, in the opinion of the
investigator, would preclude study participation
Active uncontrolled infections or other clinically relevant concomitant illness
contraindicating chemotherapy administration
Withdrawal of the consent to take part to the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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