Total Neoadjuvant Therapy in Rectal Cancer
Recruiting
Phase 2
Interventional Study
Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- National Cheng-Kung University Hospital · Other
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About This Trial
In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary en…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed diagnosis of adenocarcinoma of the rectum;
* Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
* Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
* No prior chemotherapy, radiotherapy or surger…
Contacts