Trial · NCT07472868
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete response | pCR: date of surgery sustained cCR: from date of surgery or date of entering a watch-and-wait approach, up until 1 year later. | To evaluate if neoadjuvant FOLFOXIRI leads to higher pCR rates/sustained cCR rates (≥ 1 year) compared to neoadjuvant CAPOX/FOLFOX in patients with high risk LARC. |
| Secondary | Regrowth free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including regrowth free survival. |
| Secondary | Local recurrence free survival at 3 and 5 years | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including local recurrence free survival. |
| Secondary | Distant metastasis free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including distant metastasis free survival. |
| Secondary | Progression free survival | 3 and 5 years post-treatment. | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including progression free survival. |
| Secondary | Disease free survival (DFS) | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including disease free survival. |
| Secondary | Overall survival | 3 and 5 years post-treatment | To compare long term oncological outcomes at 3- and 5 years between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, including overall survival. |
| Secondary | Successful organ preservation | 1 and 3 years post-treatment | Organ preservation, defined as no bowel resection or stoma placement at 1 and 3 years follow-up. |
| Secondary | Radiological response | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), and after chemoradiotherapy (= approximately 20-28 weeks after enrollment). | To compare radiological response between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. |
| Secondary | Pathological response | Date of surgery. | To compare pathological response between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. |
| Secondary | Toxicity, compliance and dose reductions of ICT and CRT | From onset of ICT up until 3 months after last radiation (= approximately 8-10 months after enrollment). | To compare toxicity related to ICT between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX (toxicity, compliance and dose reductions during both ICT and CRT). |
| Secondary | Completion rates of ICT and CRT | From onset of ICT up until last radiation (=approximately 20-28 weeks after enrollment). | To compare the completion rates of ICT and chemoradiotherapy, both separately and combined, between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. Calculated as a percentage from the total number of patients per group. |
| Secondary | Number of patients undergoing surgery | At surgery date. | To compare the number of patients undergoing surgery between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX, calculated as a percentage from the total number of patients per group. |
| Secondary | Surgical characteristics and post-operative morbidity | At surgery date up until 3 months after surgery. | To compare surgical characteristics and post-operative morbidity between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. Data on the surgical procedure are registered in the surgical report in the patient's medical file by the operating surgeon. Data on intraoperative radiotherapy, if administered, are registered in the patient's medical file by the radiation oncologist. Data on postoperative complications, graded according to the Clavien-Dindo grading system, are registered in the patient's medical file by the treating physician up to 3 months after surgery (44). |
| Secondary | Patient-reported quality of life measured by the QLQ-C30 questionnaire | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), after chemoradiotherapy (= approximately 20-28 weeks after enrollment), and 3 - 12 - 24 months after surgery or entering a Watch-and-Wait approach. | \* Quality of Life Questionnaire - Core 30 (QLQ-C30) * Questions regarding general symptoms and functional impairments with an answering scale ranging from 'Not at all' to 'A lot'; a higher score meaning worse quality of life; * Questions regarding patient-reported quality of life in general with an answering scale ranging from 'Very bad' to 'Excellent'; a higher score meaning better quality of life. |
| Secondary | Patient-reported quality of life measured by the QLQ-CR29 questionnaire | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), after chemoradiotherapy (= approximately 20-28 weeks after enrollment), and 3 - 12 - 24 months after surgery or entering a Watch-and-Wait approach. | Quality of Life Questionnaire - Colorectal cancer module 29 (QLQ-CR29): Questions regarding disease-specific symptoms with an answering scale ranging from 'Not at all' to 'A lot'; a higher score meaning worse quality of life; |
| Secondary | Patient-reported quality of life measured by the QLQ-CIPN-20 questionnaire. | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), after chemoradiotherapy (= approximately 20-28 weeks after enrollment), and 3 - 12 - 24 months after surgery or entering a Watch-and-Wait approach. | Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN-20): questions regarding chemotherapy-specific symptoms with an answering scale ranging from 'Not at all' to 'A lot'; a higher score meaning worse quality of life. |
| Secondary | Patient-reported quality of life, measured by the EQ-5D-5L questionnaire. | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), after chemoradiotherapy (= approximately 20-28 weeks after enrollment), and 3 - 12 - 24 months after surgery or entering a Watch-and-Wait approach. | EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L) * Questions regarding general symptoms and functional impairments on a scale of ranging from 'No problems' to 'Not able to ... at all), a higher score meaning worse quality of life. * Scale ranging from worst to best health imagineable, a higher score meaning better quality of life. |
| Secondary | Patient-reported work productivity/activity impairment (measured by WPAI-GH questionnaires) | At baseline, after induction chemotherapy (= approximately 12-14 weeks after enrollment), and after chemoradiotherapy (= approximately 20-28 weeks after enrollment) | Measured by the Work Productivity and Activity Impairment - General Health (WPAI-GH) questionnaire version 2, comprised of questions with a numeric answer (e.g., number of hours of absence from occupation in the last 7 days), and scales regarding impact of health on work productivity and activity impairment, ranging from 'no impact' to 'total impediment of doing my job'; on these scales, a higher score means greater activity impairment. |
| Secondary | Cost-effectiveness and -utility | From enrollment up until 1 year post-operatively or after entering a W&W approach. | To compare cost-effectiveness and -utility between neoadjuvant FOLFOXIRI and neoadjuvant CAPOX/FOLFOX. For the purpose of economic evaluation, the EQ-5D-5L questionnaire (see description below) is used at baseline, and 12 months post-operatively. \* EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L) * Questions regarding general symptoms and functional impairments on a scale of ranging from 'No problems' to 'Not able to ... at all), a higher score meaning worse quality of life. * Scale ranging from worst to best health imagineable, a higher score meaning better quality of life. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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