Efficacy of chemotherapy before surgery 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.
This study is testing if adding more chemotherapy before surgery helps people with non-metastatic rectal cancer do better than the standard treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Abdullah Medical City Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Mecca, Makkah Western) |
| Trial ID | NCT03957733 on ClinicalTrials.gov |
What this trial studies
This Phase II/III randomized study evaluates the effectiveness of neoadjuvant consolidation chemotherapy in patients with non-metastatic rectal cancer who are candidates for chemoradiotherapy. Participants will be assigned to either an experimental arm receiving chemotherapy after chemoradiotherapy or a standard arm undergoing surgery after chemoradiotherapy. The study aims to determine if the additional chemotherapy improves outcomes compared to the standard treatment approach. The primary focus is on assessing the efficacy of this treatment strategy in improving surgical outcomes and overall patient prognosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of rectal adenocarcinoma at specific clinical stages.
Not a fit: Patients with metastatic rectal cancer or those not eligible for total mesorectal excision may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and survival rates for rectal cancer patients.
How similar studies have performed: Previous studies have shown promise in using neoadjuvant chemotherapy for rectal cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * SGOT (AST) ≤ 3 x ULN * SGPT (ALT) ≤ 3 x ULN * Creatinine ≤1.5 x ULN or Creatinine clearance \> 50ml/minute by Cockcroft-Gault formula. * Negative pregnancy test ≤ 7 days prior to registration for women of childbearing potential only. * Patient of child-bearing potential is willing to employ an adequate contraception method * Provide informed written consent * Willing to return to the enrolling medical site for all study assessments 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. * Any investigational treatment for rectal cancer within the past year. * Pregnancy or breast feeding.
Where this trial is running
Mecca, Makkah Western
- King Abdullah Medical City, Holy Capital — Mecca, Makkah Western, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Shereef E Mohammad — King Abdullah Medical City
- Study coordinator: Rania M Felemban, MSc
- Email: felembanr@kamc.med.sa
- Phone: +96625549999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.