A Phase 3 interventional study of Capecitabine and Oxaliplatin in Rectal Neoplasms Malignant, Rectum Carcinoma and Rectal Cancer, sponsored by Blokhin's Russian Cancer Research Center. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Blokhin's Russian Cancer Research Center · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper rectal cancer.
This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to upfront surgery in intermediate risk rectal cancer patients. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy and surgery or surgery alone. A stratification will be performed based on N stage, tumor location in the middle or upper rectum and clinical center. Patients with cT3-4aN1-2M0, T4aN0M0 cancer in the upper rectum and сТ2-Т3bN1M0 (based on preoperative MRI) cancer in the middle rectum are included. All patients are potential candidates for adjuvant chemotherapy, according to preoperative staging. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage in both treatment arms, according to actual treatment guidelines. The target accrual is 280 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 10% 3-yr disease-free survival (75% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI isbject to central review. Conduction of this study and data collection are controlled by a local institutional board.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 560 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Blokhin's Russian Cancer Research Center is the lead sponsor of 32 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Patients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
Drug: Capecitabine · Drug: Oxaliplatin · Radiation: Radiotherapy · Procedure: Rectal cancer surgery
Patients will receive standard surgery for rectal cancer with partial or total mesorectal excision (based on exact tumor location and surgeons discretion). The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
Drug: Capecitabine · Drug: Oxaliplatin · Procedure: Rectal cancer surgery
2000 mg/m2, bid, per os, days 1-14, 4 cycles
Also known as: Xeloda
130 mg/m2 iv day 1, 4 cycles
825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Also known as: Xeloda
Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)
3-year disease-free survival
Time frame: 3 years
Adjuvant chemotherapy compliance
Proportion of patients who receive a complete course of adjuvant chemotherapy
Time frame: 6 months
Acute chemotherapy toxicity
Toxicity measured according to NCI-CTCAE v.5.0
Time frame: 14 weeks
pathologic complete response rate (pCR)
Time frame: 1 month
local recurrence rate
Time frame: 3 years
3-year overall survival
Time frame: 3 years
Operative morbidity
Morbidity measured according to Clavien-Dindo classification
Time frame: 30 days
Neoadjuvant chemotherapy disease progression rate
Proportion of patients with disease progression during neoadjuvant chemotherapy
Time frame: 14 weeks
Preoperative tumor-associated complications rate
The rate of tumor-associated complications (bowel obastruction, bleeding etc) during neoadjuvant chemotherapy
Time frame: 14 weeks
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Blokhin's Russian Cancer Research Center