NCT06097416Not yet recruitingPhase 3

Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer

A Phase III, Multi-institutional Randomised Trial Comparing Neoadjuvant Chemoradiotherapy (NARCT) and Total Neoadjuvant Therapy (TNT) in Patients With T3 (a/b/c) Rectal Cancer

Source: ClinicalTrials.gov · Last updated 25 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC). The primary goal of treatment is to achieve local disease control, reduce tumour volume and minimise the risk of distant metastases. While this multimodal treatment approach has offered improvements in local control and sphincter preservation, it has had little effect on distant recurrence and overall survival. We aim to compare NACRT and TME using the following endpoints: Primary --\>To compare the effects neoadjuvant chemoradiotherapy versus total neoadjuvant therapy (TNT) for T3 rectal cancer on overall survival. Secondary --\> To compare the effects neoadjuvant chemoradiotherapy (NARCT) and total neoadjuvant therapy (TNT) for cT3 rectal cancer on clinical outcomes: * Clinical complete response (cCR) * Pathological complete response (pCR) * Disease-free survival (DFS) * Organ preservation * Overall morbidity / mortality * Treatment-related morbidity / mortality * Peri-operative outcomes

Status (registry): Not yet recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 18 Oct 2023
Start date: Oct 2024
Primary completion date: Oct 2025
Lead sponsor: St. James's Hospital, Ireland
Diseases: Colorectal cancer
NCT number: NCT06097416

What you commit to

Study type: Interventional · Phase 3
Planned participants: 100
From Oct 2024 to the primary completion date, Oct 2025
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Received prior chemotherapy for local or metastatic disease.
Received prior pelvic radiotherapy.
Previous or concurrent active malignancy ≤ 5 years prior to registration with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating Investigator does not feel will impact the study objectives.
Clinically significant cardiovascular disease including:
- Cerebrovascular accident within 6 months prior to registration
- Myocardial infarction within 6 months prior to registration
- Uncontrolled angina
- Uncontrolled or poorly controlled arterial hypertension (i.e. BP \>150/90mmHg under treatment with at a maximum three antihypertensive drugs)
- Clinically significant valvular disease
- Congestive Heart Failure (NYHA \> Class 2 (See Appendix E)
- Known family history of idiopathic cardiac arrest or sudden death whereby a cardiac cause cannot be excluded
- Known history or family history of Brugada Syndrome.
Patients with a history of venous thrombotic episodes such as DVT, PE occurring more than 6 months prior to enrolment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.
Concurrent treatment with any other investigational agents within 30 days prior to registration.
Unable or unwilling to discontinue (and substitute if necessary) use of prohibited medications for at least 30 days prior to and for the duration of study treatment (see section 7.5 for a description of prohibited medications).

Other illness

Locally advanced rectal cancer; \>T3, Nodal disease
Primary unresectable rectal cancer. A tumour is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins.
Known pulmonary compromise, as determined by the treating investigator, resulting from intercurrent pulmonary illness, but not limited to, any pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease.
Patients with a history of any arterial thromobotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA or CVA.
Any psychological, physical, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; (those conditions should be discussed with the patient before registration in the trial).

Lab values

Screening electrocardiogram (ECG) with evidence of:
- QT prolongation (QTc \> 450ms in males and \> 470ms in females)
- Clinically significant cardiac arrhythmias, complete left bundle branch block, high atrioventricular AV block (e.g. bi-vascular block , Mobitz type II and third degree AV block
- Other severe cardiac dysfunction
- (ECG must be assessed for all patients within 14 days prior to registration).
Creatinine level \>1.5x ULN

Other

Patients who meet any of the following criteria at the time of screening will be excluded from study registration:
Patients unable to undergo MRI.
Pregnant or nursing women.

Criteria the registry did not label

Patients are eligible to be included in the study only if they meet all of the following criteria:
Written informed consent must be given according to ICH/GCP and national/local regulations and be obtained prior to any study-related procedures.
Histologically or cytologically confirmed surgically resectable adenocarcinoma of the rectum.
Clinical stage II (T3, N-) \\
Absence of metastatic disease
Eastern Co-operative Oncology Group (ECOG) performance status \> 2.
Age \> to 18.
Estimated life expectancy ≥ 12 months.
No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician).
Measurable disease, as defined by RECIST Version 1.1
Adequate haematological, hepatic, and renal function defined as:
- Renal: i. Calculated creatinine clearance (CrCl) \> 50ml/min (see Appendix G)
- Liver function tests: i. Total Bilirubin \< 1.5 ULN
- (OR \< 3 x ULN (\< Grade 2) in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.) ii. ALT and AST \< 2.5 x ULN (\< 5 x ULN with liver involvement of their cancer) iii. Alkaline Phosphatase \< 2.5 x ULN (\< 5 x ULN with liver involvement of their cancer)
- Haematology: i. Haemoglobin \> 9 g/dL (\< Grade 1) ii. Absolute neutrophil count \> 1.5 x 109/L iii. Platelet count \> 100 x109/L (≤ Grade 1)
Normal thyroid function defined as a TSH within normal local institutional range
Able to swallow and retain oral medication
Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential; agree to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception measures during the treatment period. For women, highly effective contraception should be used, for X months after last dose of (INSERT AGENT). For men, highly effective contraception should be used, for X months after (INSERT AGENT). (Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:
- Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable).
- Intrauterine device (IUD). iv. Intrauterine hormone-releasing system (IUS). v. Bilateral tubal occlusion. vi. Successfully vasectomised partner. vii. Sexual abstinence.)
Women of childbearing potential must have pregnancy excluded by urine or serum beta-HCG testing within 7 days prior to registration.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.