Contact Radiotherapy for Rectal Cancer

NCT06501053 | Recruiting

• 1 other identifier: CORRECT
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).

Conditions

Rectal Cancer

Keywords

organ sparing; brachytherapy; radiotherapy; nonoperative

Outcome Measures

Primary Outcomes (1)

• Rectum preservation

  Proportion of patients with successful rectum preservation after standard vs experimental treatment. Organ preservation is considered to have failed if the rectum is removed OR if the patient develops non-salvageable locoregional failure

  At 24 months after start of treatment

Secondary Outcomes (15)

• Acute treatment-related toxicity

  From start of treatment until 90 days after ending treatment

• Late treatment related toxicity

  From 90 days after ending treatment until end of study

• Clinical complete response (cCR)

  At 14-16 and 24-26 weeks after start of treatment

• Postoperative complications

  Within the first 30 days after Total Mesorectal Excision (TME) surgery

• Stoma

  At 12 and 24 months after start of treatment

Study Arms (2)

CXB + CRT

ACTIVE COMPARATOR

Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and chemoradiotherapy (CRT) 45/50 Gy (1.8/2 Gy/fraction/5 weeks) with concurrent chemotherapy using capecitabine (900 mg/m2 bid, on radiation days).

Radiation: Radiotherapy; Radiation: Contact x-ray brachytherapy; Drug: Chemotherapy

CXB + SCRT

EXPERIMENTAL

Contact x-ray brachytherapy (CXB) (90Gy/3 fractions/4 weeks) and a short-course radiotherapy (SCRT) (25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days).

Radiation: Short-course radiotherapy; Radiation: Contact x-ray brachytherapy

Interventions

Radiotherapy RADIATION

45/50 Gy (1.8/2 Gy/fraction/5 weeks)

CXB + CRT

Short-course radiotherapy RADIATION

25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days

CXB + SCRT

Contact x-ray brachytherapy RADIATION

90Gy/3 fractions/4 weeks

CXB + CRT; CXB + SCRT

Chemotherapy DRUG

Capecitabine (900 mg/m2 bid, on radiation days)

CXB + CRT

Eligibility Criteria

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

You may qualify if:

• Adenocarcinoma of the rectum classified as:
• cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0
• Performance status (ECOG) 0-1
• Operable patient
• Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
• years or above
• No comorbidity preventing treatment
• Patient having read the information note and having signed the informed consent
• Follow-up possible

You may not qualify if:

• Inoperable patient
• T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
• Distance from the lower tumor border to the anal verge \>10 cm
• N2-status at diagnosis or N1 with any node\>= 8 mm diameter
• Patient presenting with metastasis at diagnosis (M1)
• Previous pelvic irradiation
• Tumor with extramural vascular invasion
• Poorly differentiated tumor
• Simultaneous progressive cancer
• Tumor invading external anal sphincter or growth within 1 mm of the levator
• Tumor within 1 mm from MRF (mesorectal fascia)
• Patient unable to receive CXB or CRT
• Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
• Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol
• Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment

Sponsors & Collaborators

• Alexander Valdman: lead
• Uppsala University Hospital: collaborator
• Karolinska Institutet: collaborator

Study Sites (2)

Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer

Stockholm, Solna, 171 76, Sweden

RECRUITING

Uppsala University Hospital, Colorectal Surgery

Uppsala, 751 85, Sweden

RECRUITING

Related Publications (2)

• Gerard JP, Barbet N, Schiappa R, Magne N, Martel I, Mineur L, Deberne M, Zilli T, Dhadda A, Myint AS; ICONE group. Neoadjuvant chemoradiotherapy with radiation dose escalation with contact x-ray brachytherapy boost or external beam radiotherapy boost for organ preservation in early cT2-cT3 rectal adenocarcinoma (OPERA): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):356-367. doi: 10.1016/S2468-1253(22)00392-2. Epub 2023 Feb 16.

  PMID: 36801007 BACKGROUND

• Nilsson PJ, Folkesson J, Marsk R, Radu C, Stratulat I, Blomqvist L, Martling A, Valdman A. Contact radiotherapy for rectal cancer (CORRECT): study protocol for a multicentre randomised phase II trial. BMJ Open. 2025 Apr 9;15(4):e100356. doi: 10.1136/bmjopen-2025-100356.

  PMID: 40204311 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy; Drug Therapy

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)

Therapeutics

Central Study Contacts

Alexander Valdman, MD, PhD

CONTACT

+46 70 002 13 17; alexander.valdman@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Principal Investigator

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 15, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): November 1, 2032
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee. A data-sharing agreement will also be required. Contact: alexander.valdman@ki.se

Locations

SE (2)