Status:
UNKNOWN
CONVERT: Neoadjuvant Chemotherapy Alone Versus Preoperative Chemoradiation for Locally Advanced Rectal Cancer Patients
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Shantou Central Hospital
Liaoning Cancer Hospital & Institute
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More i...
Detailed Description
This randomised, open-label, multicentre,phase 3 trial began in August, 2014, as an adjuvant trial comparing capecitabine-based neoadjuvant chemoradiotherapy with chemotherapy alone,in patients aged 1...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of rectal adenocarcinoma
- Radiologically measurable or clinically evaluable disease
- Tumor location within 12cm from anal verge
- Clinical stage T2N+ or T3-4aNany,M0 Clinical staging should be estimated based on the combination of the following assessments: physical examination by the primary surgeon, CT scan of the chest/abdomen/pelvis, and a pelvic MRI with or without an endorectal ultrasound (ERUS)
- No evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on pre-operative MRI
- No tumor causing symptomatic bowel obstruction
- No distant metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0, 1
- White Blood Cell (WBC) ≥ 4,000/mm³
- Platelets ≥ 100,000/mm³
- Hemoglobin \> 10.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No co-morbid illnesses or other concurrent disease that, 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
Exclusion
- Pregnant or nursing
- Patient of child-bearing potential is not willing to employ adequate contraception
- Not willing to return to enrolling medical site for all study assessments
- With other invasive malignancy ≤ 5 years prior to registration; exceptions are colonic polyps, non-melanoma skin cancer, or carcinoma-in-situ of the cervix
- Chemotherapy within 5 years prior to registration (hormonal therapy is allowable if the disease-free interval is ≥ 5 years)
- Prior pelvic radiation
Key Trial Info
Start Date :
August 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
663 Patients enrolled
Trial Details
Trial ID
NCT02288195
Start Date
August 13 2014
End Date
March 1 2024
Last Update
May 12 2023
Active Locations (1)
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1
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China, 510060