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Phase II/III Study to Assess the Efficacy of Neoadjuvant Consolidation Chemotherapy in Rectal Cancer Patients. | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Phase II/III Study to Assess the Efficacy of Neoadjuvant Consolidation Chemotherapy in Rectal Cancer Patients.

Phase II/III Randomized Multicentre Study Comparing Neoadjuvant Chemoradiotherapy Followed by Consolidation Chemotherapy to Neoadjuvant Chemoradiotherapy Alone in Non-metastatic Rectal Cancer Patients.

NCT03957733•King Abdullah Medical City

View on ClinicalTrials.gov

Summary

This is a Phase II/III randomized study involving non-metastatic rectal cancer patients who are candidates for neoadjuvant chemoradiotherapy. Eligible patients will be randomized between two treatment arms: Experimental arm: Long course CRT is followed by 4 cycles of combination chemotherapy of modified FOLFOX6 or 3 cycles of XELOX and then surgery. After surgery, patients with pT0-2 N0 will not receive adjuvant chemotherapy. Patients with higher pathological stage will receive adjuvant chemotherapy (4 cycles of modified FOLFOX6 or 3 cycles of XELOX). Standard arm: Long course CRT will be followed by surgery 10-12 weeks after the end of CRT. After surgery, patients with pT0-2 N0 will not receive adjuvant chemotherapy. Patients with higher pathological stage will receive adjuvant chemotherapy (8 cycles of modified FOLFOX6 or 6 cycles of XELOX). The study aims to assess the efficacy of consolidation chemotherapy given in the interval between the end of CRT and surgery to allow for early initiation of systemic therapy aiming to decrease distant relapse rate and enhancing pathological response.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at diagnosis
•Histopathological diagnosis of rectal adenocarcinoma
•ECOG Performance Status (PS): 0- 2
•Clinical Stage: T2 N1-2, T3N0-2, T4 N0-2 based on pelvic MRI. Lymph node will be considered radiologically positive if: - size (short axis≥ 1cm) and/or - Morphological changes: irregular outlines/ abnormal signal intensity, positive enhancement.
•The standard treatment recommendation of included patients in the absence of a clinical trial would be combined modality neoadjuvant CRT followed by curative intent surgical resection.
•Primary surgeon is planning to perform Total Mesorectal Excision (TME).
•The following laboratory values must be obtained ≤ 28 days prior to registration:
•* Absolute neutrophil count (ANC) ≥ 1500/mm3
•* Platelet count ≥ 100,000/mm3
•* Hemoglobin \> 8.0 g/dl (transfusion permitted)
+8 more criteria

Exclusion Criteria

•Extensive growth into the sacrum or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen.
•Presence of metastatic disease or recurrent rectal tumor.
•Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis.
•Concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
•Known dihydropyrimidine dehydrogenase (DPD) deficiency.
•Any contraindications to MRI (e.g. patients with pacemakers)
•Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
•Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months.
•Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract.
•Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
+2 more criteria

Locations (1)

King Abdullah Medical City, Holy Capital

Mecca, Makkah Western, Saudi Arabia

Key Dates

Start Date

November 23, 2017

Primary Completion Date

May 30, 2022

Completion Date

November 23, 2025

Last Updated

April 6, 2022

Enrollment

338

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

Chemotherapy

DRUG

Contacts

Rania M Felemban, MSc

CONTACT

+96625549999 felembanr@kamc.med.sa

Wedian O Almowlad, MSc

CONTACT

+96625549999 Almwlld.W@kamc.med.sa

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II/III Study to Assess the Efficacy of Neoadjuvant Consolidation Chemotherapy in Rectal Cancer Patients.

Inclusion Criteria

Exclusion Criteria

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