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NCT00939666
Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer
NA trial testing Wait&see or TEM with intensive follow-up in Locally Advanced Rectal Cancer in 28 participants. Completed in 1 September 2014.
1 September 2014
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 1 July 2009 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 September 2014 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- Wait&see or TEM with intensive follow-up
Conditions studied
- Locally Advanced Rectal Cancer — all drugs for Locally Advanced Rectal Cancer →
Sponsor
Maastricht University Medical Center
Who can join
18 and older, any sex, with Locally Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whether in patients with complete or good response the overall benefits of a 'wait-and-see policy' or transanal endoscopic microsurgery (TEM) combined with intensive follow-up may outweigh the benefits associated with conventional surgery (total mesorectal excision (TME)or abdominoperineal resection (APR)). On the one hand, less invasive strategies will expose subjects to more diagnostic procedures and possibly a slightly higher risk of local failure and the need for salvage surgery. On the other hand, mortality and morbidity associated with radical surgery (e.g. anastomotic leakage, relaparotomy, wound and pelvic infection, chronic wound healing disturbances, abscess, colostomy, faecal or urinary incontinence and sexual dysfunction) can be avoided. The investigators believe that wait-and-see policy for complete responders and TEM for good responders after chemoradiation is a feasible alternative to standard surgery, provided these patients are intensively followed.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of Local Excision for Suspected Regrowth in a Watch and Wait Strategy for Rectal Cancer.
Geubels BM, Meyer VM, van Westreenen HL, Beets GL, et al · · 2022 · cited 12× · PMID 35804843 · DOI 10.3390/cancers14133071 -
Selected stage IV rectal cancer patients managed by the watch-and-wait approach after pelvic radiotherapy: a good alternative to total mesorectal excision surgery?
Custers PA, Hupkens BJP, Grotenhuis BA, Kuhlmann KFD, et al · · 2022 · cited 11× · PMID 35060263 · DOI 10.1111/codi.16034 -
The use of deep learning on endoscopic images to assess the response of rectal cancer after chemoradiation.
Haak HE, Gao X, Maas M, Waktola S, et al · · 2022 · cited 8× · PMID 34642794 · DOI 10.1007/s00464-021-08685-7
Verify or expand the search:
- PubMed search for NCT00939666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06894797 — Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer. · NA · recruiting
Other Maastricht University Medical Center trials
Trials by the same sponsor.
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- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00939666 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 24 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00939666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing