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NCT03297710
TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery
Phase 1 trial testing Quality-of-Life Assessment in Rectal Adenocarcinoma in 7 participants. Completed in 30 April 2021.
16 March 2020
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 11 December 2017 |
| Primary completion | 16 March 2020 |
| Estimated completion | 30 April 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Quality-of-Life Assessment
- Radiation Therapy — full drug profile →
- Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102 — full drug profile →
Conditions studied
- Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →
- Recurrent Rectal Carcinoma — all drugs for Recurrent Rectal Carcinoma →
- Stage IV Rectal Cancer AJCC v7 — all drugs for Stage IV Rectal Cancer AJCC v7 →
- Stage IVA Rectal Cancer AJCC v7 — all drugs for Stage IVA Rectal Cancer AJCC v7 →
Sponsor
Mayo Clinic
Who can join
18 and older, any sex, with Rectal Adenocarcinoma or Recurrent Rectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03297710
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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 NCT03297710 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 5 January 2023
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/NCT03297710.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing