Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
Recruiting
Phase 2
Phase 3
Interventional Study
Rectal Cancer
Total Neoadjuvant Treatment
Neoadjuvant Therapy
Radiotherapy
Chemotherapy
Organ Preservation
Radiotherapy Side Effect
Chemotherapy Side Effects
Chemoradiotherapy
Low Anterior Resection Syndrome
Quality of Life
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · Other
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About This Trial
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinic…
Trial Locations
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Eligibility Criteria
Part One
Inclusion Criteria:
* Over 18 years of age.
* Participants who agreed to participate in the study signed an informed consent form.
* The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.
* Pathologically confirmed rectal adenocarcinoma.
* Tumor up to 10 cm from the anus.…
Contacts