Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:50 AM
Study NCT ID:
NCT07483060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-10', 'size': 1367428, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-03-04T03:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a non-randomized, patient preference-based parallel assignment study. Eligible patients with early rectal cancer are offered a choice between standard upfront total mesorectal excision (TME) surgery and organ preservation with mesorectal chemoradiotherapy. Participants remain in their selected treatment group and are followed prospectively according to the study protocol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained clinical complete response at 1 year', 'timeFrame': '1 year', 'description': 'Proportion of participants in the organ preservation arm who achieve a clinical complete response (cCR) and remain without surgical resection at 1 year after initiation of treatment. Clinical complete response is defined by absence of residual tumor on MRI, no visible tumor on endoscopy (scar/fibrosis permitted), and no palpable tumor on clinical examination.'}], 'secondaryOutcomes': [{'measure': 'Clinical Complete Response at 3 Years', 'timeFrame': '3 years', 'description': 'Proportion of participants achieving and maintaining clinical complete response without surgical resection at 3 years.'}, {'measure': 'Local Recurrence Rate', 'timeFrame': '3 years', 'description': 'Proportion of participants developing local recurrence after initial treatment.'}, {'measure': 'Distant metastases', 'timeFrame': '3 years', 'description': 'Proportion of participants developing distant metastatic disease.'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 5 years', 'description': 'Overall survival measured from study inclusion to death from any cause.'}, {'measure': 'Organ Preservation Rate', 'timeFrame': '3 years', 'description': 'Proportion of participants with preserved rectum without permanent stoma at 3 years.'}, {'measure': 'Surgical Morbidity', 'timeFrame': 'Within 90 days after surgery', 'description': 'Postoperative complications measured using the Comprehensive Complication Index (CCI) in participants undergoing surgery.'}, {'measure': 'Total Length of Hospital Stay', 'timeFrame': 'Within 1 year after diagnosis', 'description': 'Total number of days hospitalized, including readmissions, within the first year after diagnosis.'}, {'measure': 'Patient reported quality of life', 'timeFrame': 'up to 3 years', 'description': 'Quality of life will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30. Scores range from 0-100, with higher scores representing better functioning and global health status but worse symptoms on symptom scales.'}, {'measure': 'Patient reported quality of life', 'timeFrame': 'up to 3 years', 'description': 'Quality of life related to colorectal cancer will be assessed using the European Organisation for Research and Treatment of Cancer colorectal cancer module (EORTC QLQ-CR29). Scores are linearly transformed to a 0-100 scale; higher scores on functional scales indicate better functioning, whereas higher scores on symptom scales indicate greater symptom burden.'}, {'measure': 'Bowel function', 'timeFrame': 'Up to 3 years', 'description': 'Low Anterior Resection Syndrome will be assessed using the Low Anterior Resection Syndrome (LARS) Score, a validated patient-reported outcome measure evaluating bowel dysfunction after rectal cancer surgery. Scores range from 0 to 42, with higher scores indicating more severe bowel dysfunction (0-20 = no LARS, 21-29 = minor LARS, 30-42 = major LARS).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early rectal cancer', 'organ preservation', 'watch and wait', 'chemoradiotherapy', 'clinical complete response', 'quality of life', 'low anterior resection syndrom'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether mesorectal chemoradiotherapy with a limited radiation target volume can achieve a sustained clinical complete response in patients with early-stage rectal cancer, allowing surgery to be safely deferred. Patients may choose between standard total mesorectal excision (TME) surgery or organ preservation with chemoradiotherapy followed by structured surveillance. The study aims to assess oncologic safety, organ preservation rates, and quality of life.', 'detailedDescription': 'Background and Rationale\n\nStandard treatment for early-stage rectal cancer is total mesorectal excision (TME), which provides good oncologic control but may result in substantial functional morbidity. Even in early tumors, radical surgery can lead to bowel dysfunction (including low anterior resection syndrome), urinary and sexual dysfunction, and in some cases permanent stoma formation. While oncologic outcomes are generally favorable, the long-term impact on quality of life remains significant for many patients.\n\nNeoadjuvant chemoradiotherapy (CRT) has been shown to induce tumor regression in rectal cancer, and in a subset of patients a clinical complete response (cCR) may be achieved. In such cases, surgery may potentially be deferred under strict surveillance protocols, a strategy often referred to as organ preservation or "watch and wait." Previous prospective and international studies, including STAR-TREC, have demonstrated promising rates of clinical complete response in selected patients with early rectal tumors.\n\nStudy Objectives\n\nPrimary Objective To determine whether mesorectal chemoradiotherapy (50 Gy in 25 fractions combined with capecitabine 825 mg/m² twice daily on radiotherapy days) can achieve a sustained clinical complete response at one year in patients with early rectal cancer, allowing surgery to be safely deferred.\n\nSecondary Objectives\n\n* To evaluate local recurrence and local regrowth rates\n* To assess distant metastases and overall survival\n* To evaluate organ preservation rates at 3 years\n* To assess surgical morbidity (if surgery is performed)\n* To evaluate patient-reported outcomes including quality of life, bowel function, urinary function, and sexual function\n* To perform health economic evaluation\n\nStudy Design\n\nNG-ST is a national, multicenter, prospective, non-randomized phase IV cohort study conducted under EU Regulation 536/2014 (CTR). The study is classified as a low-intervention clinical trial, as capecitabine is an authorized medicinal product used within its marketing authorization, albeit at an earlier tumor stage than standard routine.\n\nEligible patients have biopsy-confirmed rectal adenocarcinoma ≤12 cm from the anal verge and MRI-staged T1-T3b, N0/NX, M0 disease. Both TME surgery and chemoradiotherapy must be considered feasible treatment options by the multidisciplinary team (MDT).\n\nPatients are offered a choice between standard upfront TME surgery and organ preservation with mesorectal chemoradiotherapy.\n\nInterventions\n\nOrgan Preservation Arm Radiotherapy: 50 Gy delivered in 25 fractions (2 Gy per fraction), 5 days per week over 5 weeks.\n\nCapecitabine: 825 mg/m² orally twice daily on radiotherapy days.\n\nStructured response assessment is performed 6-8 weeks after completion of CRT using MRI, endoscopy, and clinical examination. Patients achieving clinical complete response enter a structured surveillance program. Patients without complete response proceed to TME surgery.\n\nStandard Surgery Arm Patients undergo total mesorectal excision (TME) according to local standards. Surgical approach is at the discretion of the treating surgeon.\n\nDefinition of Clinical Complete Response\n\n* No residual tumor or suspicious lymph nodes on MRI\n* No visible tumor on endoscopy (scar or fibrosis permitted)\n* No palpable tumor on digital rectal examination\n\nFollow-Up\n\nPatients are followed prospectively with structured surveillance including MRI, endoscopy, clinical examination, and quality-of-life questionnaires. Follow-up continues for at least three years, with longer-term survival assessment up to five years.\n\nSafety Monitoring\n\nAdverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSAR) are recorded and reported according to EU CTR requirements. Annual Safety Reports are submitted via CTIS in accordance with Article 43 of Regulation (EU) 536/2014.\n\nSignificance\n\nThe NG-ST study aims to prospectively evaluate an organ-preserving strategy that may reduce the need for radical surgery and improve long-term functional outcomes without compromising oncologic safety in selected patients with early rectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Biopsy-proven rectal adenocarcinoma\n* Tumor located \\<12 cm from the anal verge\n* MRI-staged T1-T3b tumor\n* N0 or NX (no radiologic evidence of nodal metastases)\n* M0 or MX (no radiological evidence of distant metastases)\n* ECOG performance status 0-1\n* Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options\n\nExclusion Criteria:\n\n* MRI-defined N1 or higher nodal disease\n* Distant metastases (M1)\n* MRI extramural vascular invasion (mriEMVI)\n* Threatened mesorectal fascia (≤1 mm on MRI)\n* Maximum tumor diameter \\> 40 mm\n* MRI defined mucinous tumor\n* No residual luminal tumor following prior endoscopic resection\n* Recurrent rectal cancer\n* Prior pelvic radiotherapy\n* Uncontrolled significant cardiorespiratory comorbidity\n* Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency\n* Known Gilbert's syndrome\n* Pregnancy or breastfeeding\n* Concomitant medication contraindicated with capecitabine that cannot be safely discontinued\n* Age \\<18 years"}, 'identificationModule': {'nctId': 'NCT07483060', 'acronym': 'NG-ST', 'briefTitle': 'Next Generation STAR-TREC (NG-ST) - Organ Preservation in Early Rectal Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'Next Generation STAR-TREC: A Prospective Multicenter Study Evaluating Organ Preservation With Mesorectal Chemoradiotherapy in Early Rectal Cancer', 'orgStudyIdInfo': {'id': '2025-522955-25-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesorectal chemoradiotherapy', 'description': 'Participants receive mesorectal chemoradiotherapy consisting of radiotherapy (50 Gy in 25 fractions over 5 weeks) combined with capecitabine 825 mg/m² orally twice daily on radiotherapy days. Treatment response is assessed 6-8 weeks after completion using high-resolution MRI, endoscopy, and clinical examination. Participants achieving clinical complete response enter a structured "watch and wait" surveillance program with regular MRI, endoscopy, and clinical follow-up. If incomplete response or tumor regrowth is detected at any time during surveillance, total mesorectal excision (TME) surgery is recommended according to standard of care.', 'interventionNames': ['Combination Product: Capecitabine + Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Surgery (Total Mesorectal Excision)', 'description': 'Participants undergo upfront total mesorectal excision (TME) according to standard surgical practice and national guidelines for early rectal cancer. The surgical approach (open, laparoscopic, or robotic) is at the discretion of the treating surgeon. No neoadjuvant radiotherapy is administered. Postoperative care and oncologic follow-up are conducted according to national guidelines. Participants contribute clinical, oncologic, and patient-reported outcome data for comparison with the organ preservation arm.', 'interventionNames': ['Procedure: Total Mesorectal Excision (TME)']}], 'interventions': [{'name': 'Capecitabine + Radiotherapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Capecitabine is administered orally at a dose of 825 mg/m² twice daily on radiotherapy treatment days (5 days per week) during the 5-week course of mesorectal radiotherapy. External beam radiotherapy is delivered to the primary tumor and surrounding mesorectum at a total dose of 50 Gy in 25 fractions (2 Gy per fraction), administered once daily, 5 days per week, over approximately 5 weeks, according to protocol-defined target volumes.', 'armGroupLabels': ['Mesorectal chemoradiotherapy']}, {'name': 'Total Mesorectal Excision (TME)', 'type': 'PROCEDURE', 'description': 'Total mesorectal excision (TME) is performed according to standard surgical practice for rectal cancer. The surgical approach (open, laparoscopic, or robotic) is determined by the treating surgeon in accordance with local guidelines.', 'armGroupLabels': ['Standard Surgery (Total Mesorectal Excision)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eva Angenete, MD, PhD', 'role': 'CONTACT', 'email': 'eva.angenete@gu.se', 'phone': '+46-31-342-10-00'}, {'name': 'Jennifer Park, MD, PhD', 'role': 'CONTACT', 'email': 'jennifer.park@gu.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Stockholm South General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}