A Phase 2 interventional study of radiotherapy, capecitabine, oxaliplatin in Rectal Cancer, sponsored by Uppsala University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Uppsala University · Phase 2, Interventional, and Treatment
Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative resection or a recurrence, local or distant, within three years will be treated with the short course 5 x 5 Gy radiation scheme followed by four cycles of combination chemotherapy (capecitabine and oxaliplatin) and TME surgery
The multicentre, multinational RAPIDO (Rectal cancer And Pre-operative Induction therapy followed by Dedicated Operation, EudraCT number 2010-023957-12) closed patient entry in June 2016 after having randomised the planned number of 920 patients. In the study, patients were randomised to conventional chemoradiotherapy (CRT) to 50 Gy with capecitabine followed by surgery or to short-course radiotherapy (scRT, 5 x 5 Gy), 6 cycles of oxaliplatin-capecitabine (CAPOX) followed by surgery. In the CRT arm, adjuvant chemotherapy with 8 cycles of CAPOX was optional. At the time of closure of the RAPIDO study, it was discussed in Uppsala whether CRT should be the reference treatment for these high-risk rectal cancers, the experimental treatment or an alternative. Influenced by a Polish study reported by Bujko et al in 2016 with a similar design comparing CRT with scRT followed by 3 cycles of FOLFOX), it was decided that the reference treatment for patient with primary rectal cancer at high risk of failing either locally or systemically should be scRT followed by 4 cycles of CAPOX and surgery. This regimen, identical to the experimental arm in a Chinese trial (Stellar trial (ClinicalTrials.gov NCT02533271), preliminarily revealing promising pCR rates has since then been the reference treatment for patients having the same inclusion criteria as in the RAPIDO trial. Other centres in Sweden have also decided to use this regimen as reference treatment. A formal protocol is written and approved.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 280 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Histological proof of newly diagnosed primary adenocarcinoma of the rectum
Exclusion Criteria:
Short Course Radiation Therapy (5 x 5 Gy in 1 week, scRT) followed by 4 cycles of Pre-operative Chemotherapy using capecitabine and oxaliplatin (CAPOX) and Surgery in High-risk Rectal Cancer
Combination Product: radiotherapy, capecitabine, oxaliplatin
Drug pages: Capecitabine · Oxaliplatin
5x5 Gy radiotherapy in 1 week, 4 cycles of CAPOX (capecitabine 1000 mg/m2 x2 d 1-14, oxaliplatin 130 mg/m2 d 1 every third week), surgery
Pathological complete response (pCR) rate and clinical complete response (cCR) rate
pCR assessed at pathological examination of the surgical specimen, cCR at clinical and radiological (MRI) examination
Time frame: pCR assessed directly after surgery and cCR 12 months after end of treatment if no surgery is performed (cCR)]
Disease-free survival
non-radical surgery, recurrence or death within 3 years
Time frame: 3 years
Neoadjuvant rectal score (NAR score)
Score from 0 - 100, where 0 is best
Time frame: After surgery when the patological examination of the surgical specimen is completed
Incidence of Treatment-Emergent Adverse Events
CTCAE v 4.0
Time frame: within 60 days after end of treatment
Long-term Adverse Events
CTCAE v 4.0
Time frame: 4 years after end of treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2016 to primary completion in May 2020, 46 months.
Of 185 non-industry phase 2 interventional studies under Rectal Neoplasms, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 80. This study's 46 months is below that.
Counting every sponsor, half of 195 studies reached it within 48 months; a quarter within 31 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Capecitabine · Oxaliplatin