Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers (TESAR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02371304 |
Recruitment Status :
Recruiting
First Posted : February 25, 2015
Last Update Posted : May 21, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectal Cancer | Radiation: Adjuvant chemoradiotherapy Procedure: Additional TME surgery Drug: capecitabine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 302 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Rectal Preserving Treatment for Early Rectal Cancer. A Multi-centred Randomised Trial of Radical Surgery Versus Adjuvant Chemoradiotherapy After Local Excision for Early Rectal Cancers |
Study Start Date : | October 2015 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Total Mesorectal Excision
After local excision patients will receive additional TME surgery
|
Procedure: Additional TME surgery |
Experimental: Adjuvant chemoradiotherapy
After local excision. Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum
|
Radiation: Adjuvant chemoradiotherapy
Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum Drug: capecitabine |
- Recurrence free at 3 year follow-up [ Time Frame: 3 year ]
- Treatment related morbidity [ Time Frame: 1,3 and 5 year follow-up ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Patient has had an endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer without carcinoma in the resection plane.
- Patients with carcinoma in the resection plane or in case of unreliable resection planes (EMR/ESD) no macroscopic residual tumour confirmed by endoscopy are eligible for randomisation.
- Only lesions for which TME surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded).
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3-5 cm of carcinoma or pT1, maximum size of carcinoma of 3 cm, with at least poor differentiation, Haggit 4 and/or sm3, lymphatic and/or venous invasion.
- Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size of carcinoma of 3 cm, well/moderate differentiated and without lymphatic or venous invasion.
- Complete colonoscopy, without synchronous colorectal cancer.
- cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging done within 6 weeks before randomisation.
- Adequate distant staging (X-thorax or CT-thorax and CT-abdomen) without signs of distant metastasis (cM0).
- Male or female, Age > 18 years.
- Life expectancy of at least 12 months.
- Medically fit (WHO 0-2) to undergo radical surgery and/or radiation.
-
No contraindications to chemotherapy, including adequate blood counts;
- white blood count >= 4.0 x 10 9/l
- platelet count >=100 x 109/l
- clinical acceptable haemoglobin levels
- bilirubin < 35 umol/l
- creatinine levels indicating renal clearance of >=50 ml/min
- The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
- Written (signed and dated) informed consent and be capable of co-operating with protocol.
Exclusion Criteria:
- Incomplete or inconclusive resection margin with macroscopic residual tumour.
- T1 tumour with carcinoma < 3 cm, moderate/well differentiated, without sm3, venous or lymphatic invasion.
- T1 tumour with carcinoma of >5 cm and T2 tumour with carcinoma of > 3 cm.
- Presence of metastatic disease or recurrent rectal tumour.
- Previous pelvic radiation.
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
- Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years.
- Pregnancy, breast-feeding or fertile women without active birth control.
- Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (<6 months prior to randomization), myocardial infarction (<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
- Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- History of severe and unexpected reactions to fluoropyrimidine therapy.
- Hypersensitivity to capecitabine.
- Patients with severe hepatic impairment.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Patients known with dihydropyrimidine dehydrogenase deficiency
- Any contra-indications to undergo MRI imaging.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371304
Contact: Lisanne Smits | l.j.smits@amsterdamumc.nl | ||
Contact: Jurriaan Tuynman | j.tuynman@amsterdamumc.nl |
Netherlands | |
VU University Medical Center | Recruiting |
Amsterdam, Netherlands | |
Contact: J.B. Tuynman, surgeon |
Responsible Party: | Jurriaan B. Tuynman, MD, PhD, VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT02371304 |
Other Study ID Numbers: |
NL50364.029 |
First Posted: | February 25, 2015 Key Record Dates |
Last Update Posted: | May 21, 2020 |
Last Verified: | May 2020 |
Local therapy Adjuvant chemoradiotherapy Rectal preserving |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |