Trial · NCT01333709
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ro resection rate | Within 15 days after surgery | To confirm the feasibility of a tailored management with a 90% R0 resection rate achieved for all arms. |
| Secondary | Efficiency of MRI for prognosis | Within 15 days after the surgery | To specify the efficiency of MRI for prognosis in terms of volumetry, downstaging, downsizing and CRM measurement after completion of the induction trichemotherapy. |
| Secondary | Compliance rate with neoadjuvant treatment schedule | Within 4 months after the start of treatment | To measure the compliance rate to the whole neoadjuvant schedule (induction CT + radiochemotherapy) |
| Secondary | Acute and late toxicity of neoadjuvant treatments | For the duration of treatment, as expexcted to be up to 4 months and within the 5-year follow-up | To evaluate overall toxicity of neoadjuvant treatments (induction trichemotherapy + radiochemotherapy) according to the Common Terminology Criteria for Adverse Events v4.0 (NCI CTC v4.0). |
| Secondary | Pathological complete response rate | Within 15 days after surgery | To assess the pathological complete response rate (ypT0N0) |
| Secondary | Tumor regression grade (TRG) | Within 15 days after surgery | To assess at pathologic examination the tumor regression grade (TRG) according to the Dworak classification. |
| Secondary | Perioperative and postoperative morbidity | Within 6 weeks after surgery and during the 5-year follow-up | To assess the impact of the therapeutic strategy on perioperative and postoperative morbidity. |
| Secondary | Sphincter-saving surgery rate | Up to 2 months after the end of the neoadjuvant treatment | To assess the impact of the therapeutic strategy on the rate of sphincter-saving surgery. |
| Secondary | Functional outcome | For a 5-year follow-up | To assess the long-term digestive,urinary and sexual functional results of tailored strategy |
| Secondary | Quality of life | For a 5-year follow-up | To assess the impact of treatments on quality of life according to the EORTC QLQ-C30. |
| Secondary | Local recurrence rate | For a 5-year follow-up | To measure the local recurrence rate in each treatment arm. |
| Secondary | Incidence of metastases | For a 5-year follow-up | To measure the incidence of distant metastases (liver, pulmonary, peritoneal, ganglionnary or any others) in each treatment arm. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01333709/registered