Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer

NCT07669298 | Recruiting DMC

• 2 other identifiers: KB/247/2026101156165
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are:

1. 1.Does active surveillance cause fewer serious adverse events than chemoradiotherapy within 3 years? Serious adverse events include a permanent or temporary ostomy (a surgical opening in the belly to pass stool), major bowel problems, or severe treatment-related complications.
2. 2.Is active surveillance as safe as chemoradiotherapy in preventing cancer from coming back or spreading within 3 years?
3. 3.Active surveillance group: Participants will have regular checkups, blood tests, flexible camera exams of the bowel (rectoscopy), scans of the pelvis and abdomen, and colonoscopy on a set schedule for 5 years. If cancer comes back, doctors will propose further treatment options.
4. 4.Chemoradiotherapy group: Participants will receive radiation to the pelvis along with a chemotherapy pill (capecitabine) or an intravenous (IV) chemotherapy drug (5-FU) for about 5 weeks. After treatment, they will have regular checkups and scans for 5 years.

Conditions

Rectal Cancer

Keywords

early rectal cancer; local excision; active surveillance; adjuvant chemoradiotherapy; organ preservation

Outcome Measures

Primary Outcomes (2)

• Disease-related treatment failure

  Time from randomisation to the first occurrence of: 1. Cancer specific death. 2. Non-salvageable locoregional recurrence. 3. Distant metastases.

  3 years from randomisation

• Composite severe treatment-related adverse event

  Occurrence of any of the following: 1. Stoma (permanent or temporary). 2. Major LARS (score ≥30). 3. CTCAE grade ≥3 toxicity. 4. Clavien-Dindo ≥3b complications.

  3 years from randomisation

Secondary Outcomes (14)

• Disease-free survival

  3 and 5 years after randomization

• Overall Survival

  3 and 5 years after randomization

• Stoma formation rate

  12 months, 3 years, and 5 years after randomization

• Incidence of Major Low Anterior Resection Syndrome (LARS)

  12 months, 3 years, and 5 years after treatment

• Grade 3 or Higher Treatment-Related Toxicity

  From treatment initiation through 12 months after completion of chemoradiotherapy.

Study Arms (2)

Active surveillance

EXPERIMENTAL

Other: Active surveillance

Adjuvant chemoradiotherapy

ACTIVE COMPARATOR

Radiation: Adjuvant chemoradiotherapy

Interventions

Active surveillance OTHER

Active surveillance includes physical examination, and carcinoembryonic antigen (CEA) testing every 3 months during years 1-2 and every 6 months during years 3-5. Rectoscopy is performed every 3 months during years 1-2 and every 6 months during years 3-5. Pelvic MRI is performed every 6 months for 5 years. Thoracic and abdominal CT scans are performed annually for 5 years. Colonoscopy is performed at 1 year after local excision and subsequently according to findings. Recurrences are managed according to multidisciplinary team recommendations.

Active surveillance

Adjuvant chemoradiotherapy RADIATION

Adjuvant long-course pelvic chemoradiotherapy will be initiated within 12 weeks after local excision. Radiotherapy consists of 45 Gy delivered in 25 fractions of 1.8 Gy once daily, 5 days per week, over approximately 5 weeks. Concurrent chemotherapy consists of either oral capecitabine 825 mg/m² twice daily on radiotherapy days or continuous intravenous 5-fluorouracil 225 mg/m²/day throughout radiotherapy. After treatment, follow-up includes history, physical examination, CEA testing, and flexible sigmoidoscopy every 6 months for 5 years; pelvic MRI every 6 months during the first 3 years; annual thoracic and abdominal CT for 5 years; pelvic CT after discontinuation of MRI surveillance; and colonoscopy at 1 year and thereafter according to findings.

Adjuvant chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed rectal cancer located extraperitoneally.
• Complete tumour resection (R0) by means of ESD or IMD (endoscopic or TAMIS).
• Pathological report indicative of:
• \- pT1 with at least 1 of the following features: poor histological differentiation (grade 3), vascular invasion, lymphatic invasion, high tumour budding (grade 2-3), sm2 or sm3 invasion.
• Endoscopic images or video of the tumour before local excision.
• Maximum cancer diameter ≤ 30 mm based on the pathological assessment.
• cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging must be performed within 6 weeks before randomisation.
• \- If enlarged lymph nodes are present on MRI performed after ESD/IMD (raising the possibility of reactive inflammatory change), fine needle aspiration (FNA) will be undertaken, and patients with negative FNA cytology will remain eligible.
• Adequate distant staging (thoracic and abdominal CT) without signs of distant metastasis (cM0).
• Have undergone a high-quality full colonoscopy:
• Boston Bowel Preparation Scale score equal or greater than 2 in all colonic segments.
• Documented caecal intubation.
• All polyps ≥20 mm in diameter other than the index lesion must be completely removed and assessed pathologically.
• Expected survival time of more than 12 months from randomisation.
• At least 18 years old at the time of informed consent.

You may not qualify if:

• Mesorectal tumour involvement on pelvic MRI.
• Synchronous colorectal cancer in screening colonoscopy.
• Known genetic cancer syndrome, including, but not limited to adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome.
• Known inflammatory bowel disease.
• Previously identified allergy or hypersensitivity to 5-FU or capecitabine.
• Known or suspected dihydropyridine dehydrogenase (DPD) deficiency.
• Prior receipt of pelvic radiation.
• Other contraindications to pelvic irradiation.
• Serious illness other than cancer that would preclude safe participation in the study
• Uncontrolled and significant condition, including, but not limited to, the following conditions:
• Heart failure NYHA II or above.
• Major cardiac arrhythmia.
• Myocardial infarction within 6 months before randomisation.
• Unstable angina pectoris.
• Stroke (including transient ischemic attack, TIA) within 6 months before randomisation.

Sponsors & Collaborators

• Medical University of Gdansk: lead
• University of Oslo: collaborator
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator
• Centre Hospitalier Universitaire Dupuytren de Limoges (CHUL): collaborator
• Vestre Viken Hospital Trust: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Karolinska Institutet: collaborator
• University Hospital, Akershus: collaborator
• University of Roma La Sapienza: collaborator
• Hospital Clinic of Barcelona: collaborator
• Leuven University Medical Center: collaborator
• University Hospital, Ghent: collaborator
• Sorlandet Hospital HF: collaborator
• Northern Norway Regional Health Trust: collaborator
• Helse Stavanger HF: collaborator
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator

Study Sites (3)

University Hospital, Limoges

Limoges, France

NOT YET RECRUITING

University Clinical Centre

Gdansk, 80210, Poland

RECRUITING

Institute of Oncology in Warsaw

Warsaw, Poland

RECRUITING

Related Publications (8)

• van Oostendorp SE, Smits LJH, Vroom Y, Detering R, Heymans MW, Moons LMG, Tanis PJ, de Graaf EJR, Cunningham C, Denost Q, Kusters M, Tuynman JB. Local recurrence after local excision of early rectal cancer: a meta-analysis of completion TME, adjuvant (chemo)radiation, or no additional treatment. Br J Surg. 2020 Dec;107(13):1719-1730. doi: 10.1002/bjs.12040. Epub 2020 Sep 16.

  PMID: 32936943 BACKGROUND

• Ouchi A, Komori K, Masahiro T, Toriyama K, Kajiwara Y, Oka S, Fukunaga Y, Hotta K, Ikematsu H, Tsukamoto S, Nagata S, Yamada K, Konno M, Ishihara S, Saitoh Y, Matsuda K, Togashi K, Ishiguro M, Kuwai T, Okuyama T, Ohuchi A, Ohnuma S, Sakamoto K, Sugai T, Katsumata K, Matsushita HO, Nakai K, Uraoka T, Akimoto N, Kobayashi H, Ajioka Y, Sugihara K, Ueno H; Study Group for the JSCCR-T study. How Does Omitting Additional Surgery After Local Excision Affect the Prognostic Outcome of Patients With High-risk T1 Colorectal Cancer? Ann Surg. 2024 Feb 1;279(2):290-296. doi: 10.1097/SLA.0000000000006092. Epub 2023 Sep 5.

  PMID: 37669045 BACKGROUND

• Corre F, Albouys J, Tran VT, Lepilliez V, Ratone JP, Coron E, Lambin T, Rahmi G, Karsenti D, Canard JM, Chabrun E, Camus M, Wallenhorst T, Chevaux JB, Schaefer M, Gerard R, Rouquette A, Terris B, Coriat R, Jacques J, Barret M, Pioche M, Chaussade S, Cappelle E. Impact of surgery after endoscopically resected high-risk T1 colorectal cancer: results of an emulated target trial. Gastrointest Endosc. 2024 Mar;99(3):408-416.e2. doi: 10.1016/j.gie.2023.09.027. Epub 2023 Oct 2.

  PMID: 37793506 BACKGROUND

• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

  PMID: 22504191 BACKGROUND

• Moolenaar LR, van Geffen EGM, Hazen SJA, Sluckin TC, Beets GL, Leijtens JWA, Talsma AK, de Wilt JHW, Tanis PJ, Kusters M, Hompes R, Tuynman JB; Dutch Snapshot Research Group; Collaborators Snapshot Registry. Salvageable locoregional recurrence and stoma rate after local excision of pT1-2 rectal cancer - A nationwide cross-sectional cohort study. Eur J Surg Oncol. 2025 Jun;51(6):109623. doi: 10.1016/j.ejso.2025.109623. Epub 2025 Jan 23.

  PMID: 40009914 BACKGROUND

• Serra-Aracil X, Pericay C, Cidoncha A, Badia-Closa J, Golda T, Kreisler E, Hernandez P, Targarona E, Borda-Arrizabalaga N, Reina A, Delgado S, Espin-Bassany E, Caro-Tarrago A, Gallego-Plazas J, Pascual M, Alvarez-Laso C, Guadalajara-Labajo H, Otero A, Biondo S; TAUTEM Collaborative Group. Chemoradiotherapy and Local Excision vs Total Mesorectal Excision in T2-T3ab, N0, M0 Rectal Cancer: The TAUTEM Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):783-793. doi: 10.1001/jamasurg.2025.1398.

  PMID: 40434784 BACKGROUND

• van der Schee L, Albers SC, Didden P, Lacle MM, Farina Sarasqueta A, Richir MC, Intven MPW, Tuynman JB, Hompes R, Dekker E, Vleggaar FP, Bastiaansen BAJ, Moons LMG. Results of endoscopic intermuscular dissection for deep submucosal invasive rectal cancer: a three-year follow-up study. Gut. 2025 Nov 10;74(12):1995-2003. doi: 10.1136/gutjnl-2024-334612.

  PMID: 40562523 BACKGROUND

• Moolenaar LR, Ali M, Aufenacker TJ, Beets GL, Bosker RJI, Buffart TE, Burger JW, Dekker E, Denost Q, Doornebosch PG, Duijvendijk PV, Fabry HFJ, Geijsen ED, Gerhards MF, van Grevenstein WMU, Grotenhuis BA, Hoff C, Leijtens JWA, Peeters KCMJ, Pronk A, van der Schelling GP, Sietses C, Smits AB, Toorenvliet BR, van de Ven AWH, Verdaasdonk EGG, Vuylsteke RJCLM, van Westreenen HL, de Wilt JHW, Zimmerman DDE, Lange MM, van Grieken NCT, Bastiaansen BAJ, Hompes R, Marijnen CA, Dijkgraaf MGW, Moons LMG, Tanis PJ, Cunningham C, Tuynman JB; TESAR Study Group. Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2026 May 27:S2468-1253(26)00109-3. doi: 10.1016/S2468-1253(26)00109-3. Online ahead of print.

  PMID: 42202843 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Watchful Waiting; Chemoradiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Chemoradiotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Michal Kaminski, Prof.

CONTACT

(22) 546 23 28; michal.kaminski@nio.gov.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: June 14, 2026
• Primary Completion (Estimated): June 1, 2037
• Study Completion (Estimated): June 1, 2037
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

FR (1); PL (2)