Rectal Cancer Stage IPhase 3TAUTEM-T1NCT06450574
Preoperative Chemoradiotherapy and Transanal Endoscopic Microsurgery Versus Ttransanal Endoscopic Microsurgery in T1 N0, M0 Rectal Cancer (TAUTEM-T1 Study)
A Phase 3 study testing Capecitabine (Xeloda), 50.4 Gy and Transanal Endoscopic Microsurgery (TEM) in people with Rectal Cancer Stage I, run by Corporacion Parc Tauli.
Trial summary
Introduction: The standard treatment for rectal adenocarcinoma is total mesorectal excision (TME), a technique involving resection of the rectum, with or without a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Stage I
- What is being tested?
- Capecitabine (Xeloda), 50.4 Gy and Transanal Endoscopic Microsurgery (TEM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication by multidisciplinary committee of indication for local excision, according to ESMO and NCCN criteria.
- Rectal adenocarcinomas in the biopsy, located at a distance from the anal margin less than or equal to 10 cm measured by rigid rectoscopy at the time of ER.
- Preoperative staging by ER and pelvic MRI of T1,N0. In case of disparity, higher staging will be considered the definitive diagnosis. If it is greater than T1, it will be excluded.
- Tumors equal to or less than 4 cm in maximum diameter measured by MRI.
- ASA index equal to or less than III.
- Absence of distant metastases by abdominal CT and chest X-ray (if inconclusive, Thoracic CT)
Who cannot join
- Preoperative staging by EER or pelvic MRI higher than T1 or N0.
- Presence of distant metastases. Synchrony with other colorectal adenocarcinomas.
- Undifferentiated rectal adenocarcinomas or with the presence of poor prognostic factors in the preoperative biopsy (undifferentiated, venous, lymphatic or perineural infiltration, budding) .
- Patients with intolerance to preoperative chemotherapy or radiotherapy.
- Do not sign informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Controlled and Randomized Phase III Multicentric Study of the Treatment of T1,N0,M0 Rectal Cancer. Neoadjuvant Therapy and Transanal Endoscopic Surgery vs. Transanal Endoscopic Surgery (TAUTEM-T1 Study)
Introduction: The standard treatment for rectal adenocarcinoma is total mesorectal excision (TME), a technique involving resection of the rectum, with or without a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. On the other hand, transanal endoscopic surgery (TEM) allows access to tumors up to 20 cm from the anal margin, with much lower postoperative morbidity and without the need for ostomy. For T1, N0, M0 rectal adenocarcinomas without poor prognostic factors, TEM is the technique of choice. However, recent studies have described local recurrences of up to 20%. Our group, TAUTEM, has just completed a phase III clinical trial in T2-T3ab, N0, M0 rectal cancer, comparing preoperative chemoradiotherapy (CRT) and TEM versus TME, with very positive results in terms of postoperative morbidity, quality of life, and a local recurrence rate of 7.4%, not inferior to TME.
These results encourage our TAUTEM group to launch a similar project at the T1, N0, M0 stage, comparing standard TEM treatment versus QRT and TEM, aiming to improve rectal preservation outcomes and enhance results regarding local recurrence, distant recurrence, and oncologic survival.
Read more
Method: Prospective, controlled, randomized phase III multicenter clinical trial. Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size, staged as T1, N0, M0, will be included. These patients will be randomized into two groups: TEM after CRT and TEM alone. Postoperative morbidity and mortality, CRT side effects, and quality of life will be recorded. The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years. The sample size calculation for the study will be 106 patients.
Conclusions: The aim of the study is to improve oncological outcomes in stage T1, N0, M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery (TEM).
- Conditions
- Rectal Cancer Stage I
- Being tested
- Capecitabine (Xeloda), 50.4 Gy, Transanal Endoscopic Microsurgery (TEM), Transanal Endoscopic Microsurgery
- Keywords
- Preoperative chemoradiotherapy, Transanal endoscopic microsurgery, Rectal Cancer, T1-N0-M0 Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
50.4 GyRadiation
Radiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area
Transanal Endoscopic Microsurgery (TEM)Procedure or surgery
Also called Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)
10 weeks after Chemoradiotherapy
Transanal Endoscopic MicrosurgeryProcedure or surgery
Also called Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)
Standard surgical treatment of T1, N0, M0 rectal cancer. Early after diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy+TEM | Experimental | Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 10 weeks, transanal endoscopic microsurgery (TEM) is done Receives: Drug: Capecitabine (Xeloda); Radiation: 50.4 Gy; Procedure: Transanal Endoscopic Microsurgery (TEM) |
| ransanal endoscopic microsurgery (TEM) | Active comparator | Transanal endoscopic microsurgery (TEM) Receives: Procedure: Transanal Endoscopic Microsurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal preservation in T1,N0,M0 rectal cancer
Number of patients where local surgery has been maintained after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.
Measured: 2 years
Total mesorectal excision in T1,N0,M0 rectal cancer
Number of patients with Total mesorectal Excision (TME) after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.
Measured: 2 years
Secondary outcomes (6)
Analysis of tolerance and side effects of preoperative chemoradiotherapy (CRT).
NCI Common Terminology Criteria for Adverse Events v3.0 after chemoradiotherapy, is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
Measured: 30 days after preoperative CRT
Postoperative morbidity and mortality in both groups.
Postoperative (30 days post-surgery): nosocomial, surgical, and non-surgical postoperative complications; complications according to the Dindo-Clavien classification and the CCI (Comprehensive Complication Index); hospital stay.
Measured: 30 days after surgery
The clinical and pathological response of patients undergoing CRT.
The presence of a correct histological response after chemoradiotherapy is determined by the pathology study of the tumor excised after TEM, in order to establish TRG1 in Bouzourene's classification
Measured: 30 days after surgery
Quality of life one year after surgery.
Law anterior resection syndrom (LARS), Wexner incontinence scale, EORTC QLQ-C30, EORTC QLQ-CR29, and Karnofsky quality of life questionnaires. Before treatment and One year after surgery en both groups
Measured: One year after surgery
Local recurrence in both groups
Local recurrence defined as the presence of adenocarcinoma in the biopsy on the residual scar, anastomosis, or the defect area of the excised tumor.
Measured: At two years
3-year survival results in both groups,
3-year survival results in both groups, reflected in overall survival, disease-free survival (DFS), distant recurrence (DR), and rectal cancer survival.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rectal Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Serra-Aracil, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450574
- Sponsor's protocol ID
- TAUTEM-T1_2024-01
- Acronym
- TAUTEM-T1
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: SAP, Study Protocol, Informed Consent Form (ICF)
Publications
Serra-Aracil X, Pericay C, Badia-Closa J, Golda T, Biondo S, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Vallribera F, Caro A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo HG, Mora-Lopez L. Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study). Ann Oncol. 2023 Jan;34(1):78-90. doi: 10.1016/j.annonc.2022.09.160. Epub 2022 Oct 8.
PubMed 36220461Serra-Aracil X, Pericay C. Reply to the Letter to the Editor 'The role of chemoradiotherapy in organ preservation for rectal cancer' by L. Xie, Q. Chen, and J. Zhu. Ann Oncol. 2023 Apr;34(4):440-442. doi: 10.1016/j.annonc.2022.12.011. No abstract available.
PubMed 37061250Casalots A, Serra-Aracil X, Mora-Lopez L, Garcia-Nalda A, Pericay C, Ferreres JC, Navarro-Soto S. T1 Rectal Adenocarcinoma: a Different Way to Measure Tumoral Invasion Based on the Healthy Residual Submucosa with Its Prognosis and Therapeutic Implications. J Gastrointest Surg. 2021 Oct;25(10):2660-2667. doi: 10.1007/s11605-021-04948-9. Epub 2021 Feb 24.
PubMed 33629231Serra-Aracil X, Pericay C, Golda T, Mora L, Targarona E, Delgado S, Reina A, Vallribera F, Enriquez-Navascues JM, Serra-Pla S, Garcia-Pacheco JC; TAU-TEM study group. Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME). Int J Colorectal Dis. 2018 Feb;33(2):241-249. doi: 10.1007/s00384-017-2942-1. Epub 2017 Dec 12.
PubMed 29234923Naik DN, Kaneda T. Biosynthesis of branched long-chain fatty acids by species of Bacillus: relative activity of three alpha-keto acid substrates and factors affecting chain length. Can J Microbiol. 1974 Dec;20(12):1701-8. doi: 10.1139/m74-263. No abstract available.
PubMed 4155346Serra-Aracil X, Nonell A, Gener-Jorge C, Pericay C, Golda T, Kreisler E, Espin-Basany E, Pallisera A, Badia-Closa J, Espina B, Borda-Arrizabalaga N, Reina A, Guadalajara-Labajo H, Otero A, Delgado S, Kraft M, Querol R, Flor B, Pellino G, Biondo S, Caro-Tarrago A; TAUTEM-T1 collaborative group. Chemoradiotherapy and transanal endoscopic surgery versus transanal endoscopic surgery alone in T1N0M0 rectal cancer: a multicenter, randomized, controlled, phase III clinical trial (TAUTEM-T1 study). Int J Colorectal Dis. 2026 Apr 23;41(1):96. doi: 10.1007/s00384-026-05112-y.
PubMed 42026347
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled and Randomized Phase III Multicentric Study of the Treatment of T1,N0,M0 Rectal Cancer. Neoadjuvant Therapy and Transanal Endoscopic Surgery vs. Transanal Endoscopic Surgery (TAUTEM-T1 Study)
- ClinicalTrials.gov ID
- NCT06450574
- Acronym / sponsor ID
- TAUTEM-T1 / TAUTEM-T1_2024-01
- Conditions
- Rectal Cancer Stage I
- Keywords
- Preoperative chemoradiotherapy, Transanal endoscopic microsurgery, Rectal Cancer, T1-N0-M0 Rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: The standard treatment for rectal adenocarcinoma is total mesorectal excision (TME), a technique involving resection of the rectum, with or without a temporary or permanent stoma. TME is associated with high morbidity and genitourinary alterations. On the other hand, transanal endoscopic surgery (TEM) allows access to tumors up to 20 cm from the anal margin, with much lower postoperative morbidity and without the need for ostomy. For T1, N0, M0 rectal adenocarcinomas without poor prognostic factors, TEM is the technique of choice. However, recent studies have described local recurrences of up to 20%. Our group, TAUTEM, has just completed a phase III clinical trial in T2-T3ab, N0, M0 rectal cancer, comparing preoperative chemoradiotherapy (CRT) and TEM versus TME, with very positive results in terms of postoperative morbidity, quality of life, and a local recurrence rate of 7.4%, not inferior to TME.
These results encourage our TAUTEM group to launch a similar project at the T1, N0, M0 stage, comparing standard TEM treatment versus QRT and TEM, aiming to improve rectal preservation outcomes and enhance results regarding local recurrence, distant recurrence, and oncologic survival.
Method: Prospective, controlled, randomized phase III multicenter clinical trial. Patients with rectal adenocarcinoma within 10 cm of the anal margin and up to 4 cm in size, staged as T1, N0, M0, will be included. These patients will be randomized into two groups: TEM after CRT and TEM alone. Postoperative morbidity and mortality, CRT side effects, and quality of life will be recorded. The minimum follow-up will evaluate rectal preservation and local recurrence and survival at two and three years. The sample size calculation for the study will be 106 patients.
Conclusions: The aim of the study is to improve oncological outcomes in stage T1, N0, M0 rectal cancer through preoperative chemoradiotherapy associated with local surgery (TEM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy+TEM | Experimental | Drug: Capecitabine (Xeloda), Radiation: 50.4 Gy, Procedure: Transanal Endoscopic Microsurgery (TEM)Preoperative chemotherapy: capecitabine 825 mg/m2 every 12 hours orally, plus Radiotherapy (50.4 Gy). After 10 weeks, transanal endoscopic microsurgery (TEM) is done |
| ransanal endoscopic microsurgery (TEM) | Active comparator | Procedure: Transanal Endoscopic MicrosurgeryTransanal endoscopic microsurgery (TEM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Indication by multidisciplinary committee of indication for local excision, according to ESMO and NCCN criteria.
- Rectal adenocarcinomas in the biopsy, located at a distance from the anal margin less than or equal to 10 cm measured by rigid rectoscopy at the time of ER.
- Preoperative staging by ER and pelvic MRI of T1,N0. In case of disparity, higher staging will be considered the definitive diagnosis. If it is greater than T1, it will be excluded.
- Tumors equal to or less than 4 cm in maximum diameter measured by MRI.
- ASA index equal to or less than III.
Key exclusion criteria (5 listed)
- Preoperative staging by EER or pelvic MRI higher than T1 or N0.
- Presence of distant metastases. Synchrony with other colorectal adenocarcinomas.
- Undifferentiated rectal adenocarcinomas or with the presence of poor prognostic factors in the preoperative biopsy (undifferentiated, venous, lymphatic or perineural infiltration, budding) .
- Patients with intolerance to preoperative chemotherapy or radiotherapy.
- Do not sign informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine (Xeloda)Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy | Drug | Chemoradiotherapy+TEM |
| 50.4 GyRadiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area | Radiation | Chemoradiotherapy+TEM |
| Transanal Endoscopic Microsurgery (TEM)Also: Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)10 weeks after Chemoradiotherapy | Procedure or surgery | Chemoradiotherapy+TEM |
| Transanal Endoscopic MicrosurgeryAlso: Transanal Endoscopic Operation (TEO), Transanal Minimal Invasive Surgery (TAMIS)Standard surgical treatment of T1, N0, M0 rectal cancer. Early after diagnosis | Procedure or surgery | ransanal endoscopic microsurgery (TEM) |
Primary outcome
Rectal preservation in T1,N0,M0 rectal cancer
Time frame: 2 years
Number of patients where local surgery has been maintained after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.
Total mesorectal excision in T1,N0,M0 rectal cancer
Time frame: 2 years
Number of patients with Total mesorectal Excision (TME) after applying the protocol exit criteria.minimum follow-up of 2 years in both groups.
6 secondary outcomes
Analysis of tolerance and side effects of preoperative chemoradiotherapy (CRT).
Time frame: 30 days after preoperative CRT
Postoperative morbidity and mortality in both groups.
Time frame: 30 days after surgery
The clinical and pathological response of patients undergoing CRT.
Time frame: 30 days after surgery
Quality of life one year after surgery.
Time frame: One year after surgery
Local recurrence in both groups
Time frame: At two years
3-year survival results in both groups,
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Background: PubMed 36220461Serra-Aracil X, Pericay C, Badia-Closa J, Golda T, Biondo S, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Vallribera F, Caro A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo HG, Mora-Lopez L. Short-term outcomes of chemoradiotherapy and local excision versus total mesorectal excision in T2-T3ab,N0,M0 rectal cancer: a multicentre randomised, controlled, phase III trial (the TAU-TEM study). Ann Oncol. 2023 Jan;34(1):78-90. doi: 10.1016/j.annonc.2022.09.160. Epub 2022 Oct 8.
- Background: PubMed 37061250Serra-Aracil X, Pericay C. Reply to the Letter to the Editor 'The role of chemoradiotherapy in organ preservation for rectal cancer' by L. Xie, Q. Chen, and J. Zhu. Ann Oncol. 2023 Apr;34(4):440-442. doi: 10.1016/j.annonc.2022.12.011. No abstract available.
- Background: PubMed 33629231Casalots A, Serra-Aracil X, Mora-Lopez L, Garcia-Nalda A, Pericay C, Ferreres JC, Navarro-Soto S. T1 Rectal Adenocarcinoma: a Different Way to Measure Tumoral Invasion Based on the Healthy Residual Submucosa with Its Prognosis and Therapeutic Implications. J Gastrointest Surg. 2021 Oct;25(10):2660-2667. doi: 10.1007/s11605-021-04948-9. Epub 2021 Feb 24.
- Results publication: PubMed 29234923Serra-Aracil X, Pericay C, Golda T, Mora L, Targarona E, Delgado S, Reina A, Vallribera F, Enriquez-Navascues JM, Serra-Pla S, Garcia-Pacheco JC; TAU-TEM study group. Non-inferiority multicenter prospective randomized controlled study of rectal cancer T2-T3s (superficial) N0, M0 undergoing neoadjuvant treatment and local excision (TEM) vs total mesorectal excision (TME). Int J Colorectal Dis. 2018 Feb;33(2):241-249. doi: 10.1007/s00384-017-2942-1. Epub 2017 Dec 12.
- Results publication: PubMed 4155346Naik DN, Kaneda T. Biosynthesis of branched long-chain fatty acids by species of Bacillus: relative activity of three alpha-keto acid substrates and factors affecting chain length. Can J Microbiol. 1974 Dec;20(12):1701-8. doi: 10.1139/m74-263. No abstract available.
- Derived from this study: PubMed 42026347Serra-Aracil X, Nonell A, Gener-Jorge C, Pericay C, Golda T, Kreisler E, Espin-Basany E, Pallisera A, Badia-Closa J, Espina B, Borda-Arrizabalaga N, Reina A, Guadalajara-Labajo H, Otero A, Delgado S, Kraft M, Querol R, Flor B, Pellino G, Biondo S, Caro-Tarrago A; TAUTEM-T1 collaborative group. Chemoradiotherapy and transanal endoscopic surgery versus transanal endoscopic surgery alone in T1N0M0 rectal cancer: a multicenter, randomized, controlled, phase III clinical trial (TAUTEM-T1 study). Int J Colorectal Dis. 2026 Apr 23;41(1):96. doi: 10.1007/s00384-026-05112-y.
- Individual participant dataSharing planned: Undecided. SAP, Study Protocol, Informed Consent Form (ICF)
Related trials for Rectal Cancer Stage I
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine (Xeloda), 50.4 Gy and Transanal Endoscopic Microsurgery (TEM) in people with Rectal Cancer Stage I, run by Corporacion Parc Tauli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Serra-Aracil, MD (+34937231010, jserraa@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectal preservation in T1,N0,M0 rectal cancer (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450574, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.