A Phase 2 interventional study of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME and concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX in Rectal Cancer, Pathological Complete Response and Disease Free Survival, sponsored by Peking University People's Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-22.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with high-risk rectal cancer defined by MRI.
This is the randomized controlled, multi-centers, and open-labeled study. Delivering systemic chemotherapy between concurrent capecitabine-based long-term radiotherapy and total mesorectal excision (TME) surgery would be more effectively improved local control rates and improved metastases-free survival rates. The investigators attempted to investigate the effect on pathological response of delivering 4 cycles XELOX between concurrent capecitabine-based long-term radiotherapy and TME with lengthening the interval from radiation to surgery. In this study, the participants with high risk of deeper infiltration, or extramural vessel invasion, or circumferential resection margin involvement, or surrounding organs and structures invaded et al. were recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will receive best current practice of concurrent capecitabine-based long-term radiotherapy followed by TME and then a 6 cycles of XELOX as standard adjuvant chemotherapy. The participants in the intervention arm will receive concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX as neoadjuvant chemotherapy pre- a delayed TME.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's planned enrollment of 244 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
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Exclusion Criteria:
experimental group (arm B): concurrent capecitabine-based long-term radiotherapy, 4 cycles of XELOX as neoadjuvant chemotherapy and TME surgery
Drug: concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME
control group (arm A): concurrent capecitabine-based long-term radiotherapy, TME surgery and 6 cycles of XELOX as adjuvant chemotherapy.
Drug: concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX
concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted. XELOX: Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks Surgery Procedure: Total Mesorectal Excision
concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted. XELOX: Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks Surgery Procedure: Total Mesorectal Excision
Pathological complete response rate
Pathological complete response (pCR) rate between control and intervention arm
Time frame: up to 30days after total mesorectal excision
Disease Free Survival
Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death.
Time frame: 3-year
R0 of total mesorectal excision rate
Overall R0 of total mesorectal excision rate between the control and intervention arm
Time frame: up to 30days after total mesorectal excision
Surgery morbidity
Surgical morbidity reported according to Clavien-Dindo classification
Time frame: 30 days and 12-months
quality of surgery
Quality of surgery determined using the mesorectal grading system
Time frame: Time of surgery
Plan to share: Yes
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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