Clinical trial · Observational
"Watch and Wait" After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
"Watch and Wait" in Patients With Complete Clinical Response (cCR) After Neo-adjuvant Chemoradiotherapy for Primary Locally Advanced Rectal Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Suspicion of adverse events
Summary
Brief summary (as posted)
Among patients treated for locally advanced rectal cancer with neo-adjuvant radio-chemotherapy, about 15% will have complete clinical response in terms of no visible tumor or ulcerations on the site of the primary tumor, or whitening of the rectal wall or telangiectasia. In this Norwegian national multicenter observational study, patients with complete clinical response (cCR) after neo-adjuvant treatment for rectal cancer as defined by national guidelines, will be invited to a Watch\&Wait program with a specially designed follow-up in order to see if the tumor has disappeared permanently, or if there is regrowth of the tumor. Primary endpoint is the true regrowth rate in an unselected national cohort of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of regrowth
- timeFrame
- Baseline to 5 years
- description
- rate of regrowth of tumor after initial complete clinical response (cCR) in patients who undergo a specially designed Watch \& Wait program and without surgical removal of the rectum; to determine the positive predictive value of cCR.
Secondary outcomes (7)
- measure
- The rate of cCR after preoperative CRT
- timeFrame
- Baseline to 5 years
- description
- To calculate the rate of cCR in an national unselected cohort
- measure
- Metachronous distant metastases in patients following the W&W protocol
- timeFrame
- Baseline to 5 years
- description
- To calculate the rate of the occurrence of distant metastases in patients who undergo the watch \& Wait program
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified adenocarcinoma of the rectum within 15 cm from the anal verge measured by rigid proctoscopy * Patients who have completed neoadjuvant treatment according to national guidelines for rectal cancer, i.e., radiotherapy or chemo-radiotherapy (at least 40 Gy) or short-course radiotherapy combined with chemotherapy * Patients aged ≥18 years of age are eligible for inclusion. However, patients aged ≤40 years are recommended to undergo surgery on the theoretical base of a possibly more aggressive tumour disease in this age group, and will be asked to participate in the study by consenting to recording of data. Those patients who insist on W\&W approach after careful consideration and well-documented informed consent are eligible for entering the W\&W protocol. * Given informed consent * Stage I-III rectal cancer; however, patients with limited liver metastases who undergo primary liver surgery as part of a "liver first" treatment approach may be included Exclusion Criteria: * Patients without cCR * Patients unable to give informed consent * Patients with short course radiotherapy (5x5 Gy) without additional chemotherapy, or patients receiving less than 40 Gy in long course CRT * Patients with cCR but with increasing tumour growth on MRI after preoperative treatment * Patients with metastatic disease at the time of diagnosis with the exception of those who are eligible for "liver first" treatment approach as part of an intention to cure approach. * Patients previously diagnosed and treated for malignant disease in the pelvic region with radio- or chemoradiotherapy * Other circumstances that may interfere with successful participation in the W\&W protocol
References
Publications (0)
Data not yet available