NCT04443543Not yet recruitingPhase 2
An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer
Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Chemoradiotherapy: A Multi-centre, Adaptive-design, Phase II Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 30 Jun 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is designed to test the hypothesis that the clinical complete response (CCR) rate of patients with locally advanced rectal cancer (LARC) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, DFS and OS.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- First submitted
- 20 Jun 2020
- Start date
- 22 Jun 2020
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT04443543
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 222
- From 22 Jun 2020 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- serious medical illness
Lab values
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
Other
- pregnancy or breast-feeding women
- difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline CEA\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed.
- DPD deficiency
- UGT1A1\*28 7/7
Who the study is looking for
- pathological confirmed adenocarcinoma
- clinical stage T2-4 and/or N+, inappropriate for local excision
- the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons.
- Strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy.
- without distance metastases
- aged between 18 to 75 years old.
- performance status score: 0\~1
- UGT1A1\*28 6/6 or 6/7
- sign the inform consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Cencer Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.