- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957733
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.
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Rania M Felemban, MSc
- Phone Number: 18013 +96625549999
- Email: felembanr@kamc.med.sa
Study Contact Backup
- Name: Wedian O Almowlad, MSc
- Phone Number: 18004 +96625549999
- Email: Almwlld.W@kamc.med.sa
Study Locations
-
-
Makkah Western
-
Mecca, Makkah Western, Saudi Arabia, 21955
- Recruiting
- King Abdullah Medical City, Holy Capital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental arm
Long course CRT is followed by 4 cycles of combination chemotherapy of modified FOLFOX6 or 3 cycles of XELOX (capecitabine and oxaliplatin) and surgery.
Consolidation chemotherapy will start 2-4 weeks after the end of CRT.
Surgery will be performed 2-4 weeks after the last chemotherapy cycle.
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).
|
Long course CRT is followed by 4 cycles of combination chemotherapy of modified FOLFOX6 or 3 cycles of XELOX (capecitabine and oxaliplatin) and then surgery
Other Names:
|
NO_INTERVENTION: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic complete response rate (pCR).
Time Frame: 3 years
|
pCR will be defined as the absence of viable tumor cells in the primary tumor and in the lymph nodes (ypT0N0) by histopathological assessment of the surgical specimen at the time of definitive rectal surgery.
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3 years
|
3-year disease free survival (DFS) rate.
Time Frame: 3 years
|
3-year DFS will be defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of randomization
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 5 years
|
defined as the time from randomization to death from any cause
|
5 years
|
Radiological response by MRI imaging before surgery.
Time Frame: 3 years
|
3 years
|
|
Short and long-term toxicity.
Time Frame: 3 - 5 years
|
According to common toxicology criteria of adverse events, version 3
|
3 - 5 years
|
Surgical complications.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shereef E Mohammad, King Abdullah Medical City
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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