A Phase 2 interventional study of Capecitabine and FOLFOX regimen (oxaliplatin/leucovorin/5FU) in Colorectal Neoplasm, Colorectal Cancer and Rectal Neoplasms, sponsored by Zealand University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Zealand University Hospital · Phase 2, Interventional, and Treatment
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse.
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided.
Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.
The standard treatment of locally advanced but resectable cancer in the middle or lower rectum is preoperative radio-chemotherapy and in the upper part initial surgery. The clinical benefit from radio-chemotherapy is primarily through a reduction in local relapse but the treatment is associated with acute toxicity and long term functional dysfunction. Subsequently, it is important to select patients with high risk of local relapse. Intense systemic combination chemotherapy reduces the risk of distant relapse and increases survival in the postoperative setting. The biological rationale is eradication of micrometastases and hence it may be anticipated that earlier, i.e. neoadjuvant, combination therapy may improve systemic control.
Exclusion Criteria:
Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy
Drug: Capecitabine
Neoadjuvant chemotherapy with CAPOX (oxaliplatin/capecitabine) or FOLFOX regimen (oxaliplatin/leucovorin/5FU), according to institutional practice
Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU) · Drug: CAPOX (oxaliplatin/capecitabine)
Radio-chemotherapy with 50.4 Gy in 28 fractions to tumor and regional lymph nodes concomitantly with capecitabine 825 mg/m2 b.i.d
Six cycles: Oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every two weeks.
Also known as: FOLFOX (oxaliplatin/leucovorin/5FU)
Four cycles: Oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.
Disease free survival
All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually until the number of events is reached and the trial is stopped (max 5 years)
Time frame: 5 years
Overall survival
All patients will be evaluated with CT and MRI scans and clinically every 6 months for 2 years and annually for maximum 5 years
Time frame: 5 years
Local relapse
Defined to be within the pelvis. Any relapse should be verified by biopsy
Time frame: 5 years
Distant relapse
Defined to be outside the pelvis. Any relapse should be verified by biopsy
Time frame: 5 years
Early toxicity
Evaluated using CTCEA (Common Terminology Criteria for Adverse Events) version 4.
Time frame: 5 years
Late toxicity
Evaluated using CTCEA version 4.
Time frame: 5 years
Functional outcome
Measured with LARS questionnaire
Time frame: 5 years
Quality of life (QoL)
Measured with EORTC QoL questionnaire
Time frame: 5 years
Plan to share: Undecided — Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital