Trial · NCT01333709
Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma
NCT01333709, Phase 2, Completed, Institut du Cancer de Montpellier - Val d'Aurelle
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma. Trials, record NCT01333709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01333709
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Phase 2 Trial: a Tailored Strategy for Locally Advanced Rectal Carcinoma
- NCT number
- NCT01333709
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Conditions
- Locally Advanced Malignant Neoplasm, Rectal Carcinoma
- Interventions
- Induction trichemotherapy - FOLFIRINOX regimen, Early tumor response evaluation by MRI volumetry, Radiochemotherapy Cap 50, Radiochemotherapy Cap 60, Radical proctectomy with total mesorectal excision
- First posted
- 2011-04-12
- Last updated
- 2017-08-21
- Other registries' IDs
- eudract:2010-023546-73
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01333709
GET https://conductscience.org/api/trials/v1/NCT01333709/registered