A Phase 2 interventional study of Capecitabine, Oxaliplatin and External beam radiotherapy in Rectal Cancer, Rectal Cancer Stage II and Rectal Cancer Stage III, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.
A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.
The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.
The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.
1,761 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 98 is above the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Neoadjuvant chemotherapy Capeox (Capecitabine + Oxaliplatin), 6 cycles; adjuvant chemotherapy, Capecitabine, 2 cycles or physicians' decision. External beam radiotherapy: Neoadjuvant, 50 Gy, 2 Gy/session; 25 fractions. Procedure: 'Watch and wait strategy' or surgery including local excision, intersphincter resection or total mesorectal excision or other kinds of surgeries.
Drug: Capecitabine, Oxaliplatin · Radiation: External beam radiotherapy · Procedure: Surgery · Other: Watch and wait strategy
Drug: Capecitabine, Oxaliplatin
External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume
'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries
Watch and wait strategy recommendation and discussion for cCR patients
Rate of clinical complete response
Rate of clinical complete response
Time frame: 1.5 year after diagnosis
Ratio of sphincter preservation strategy
Number of patients with sphincter preservation through Watch and wait strategy, or local excision, or intersphincter resection, or low anterior resection, etc.
Time frame: 1.5 year after diagnosis
Rate of pathological complete response and tumor regression grade distribution
Rate of pathological complete response and tumor regression grade distribution
Time frame: 1.5 year after diagnosis
Acute toxicity
Acute toxicity according to CTCAE 5.0
Time frame: Within the first course of anti-tumor treatment
Rate of surgical complications
Rate of surgical complications
Time frame: 1.5 year after diagnosis
Long-term anal function
Long-term anal function according to Wexner Continence Grading Scale
Time frame: 1.5 year after diagnosis
Long-term toxicity grading
Long-term toxicity grading according to CTCAE 5.0
Time frame: 3 year after the end of the first course of anti-tumor treatment
ECOG standard score
ECOG standard score
Time frame: 1.5 year after diagnosis
3 year disease free survival
3 year disease free survival
Time frame: 3 year after the end of the first course of anti-tumor treatment
5 year overall survival
5 year overall survival
Time frame: 5 year after the end of the first course of anti-tumor treatment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University